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Report for Clinical Trial NCT04204551

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Effect of High Intensity Interval Training on Mechanisms of Neuroplasticity and Psychomotor Behaviours in Parkinson's Disease Patients: a Randomized Study With 1-year Follow up

There are experimental evidences of the important role of high intensity physical exercise in Parkinson's disease (PD) treatment, that induces similar effects to pharmacotherapy. So far, the mechanisms of the impact of these changes on the brain subcortical and cortical regions functioning, motor activities and cognitive functions are still not clear. The aim of this longitudinal (prospective) human experiment is to examine the effects of two cycles of 12-weeks high-intensity interval training (HIIT) on: (i) the level of dopamine (DA) in putamen in striatum, (ii) neurophysiological function of subcortical and cortical motor structures and skeletal muscle activity, (iii) psychomotor behaviors critically associated with dopamine dependent neural structures functioning and (iv) neurotrophic factors' secretion level in blood. The investigators will recruit 40 PD individuals, who will be divided into two groups: one of them will perform two 12-weeks cycles of HIIT (PD-TR), and the other will not be trained (PD-NTR) with HIIT. The investigators will also recruit 20 age-matched healthy controls (H-CO) as additional control group who will not perform the HIIT. The PD-TR group will perform the two 12-weeks cycles of the HIIT, that induces beneficial, neuroplastic changes and alleviates the PD symptoms, what was found in earlier studies. All PD subjects (PD-TR and PD-NTR) will be examined during their medication "OFF-phase" (it means after dopaminergic drugs withdrawal) before (Pre) and after (Post) training cycles (first training cycle - HIIT 1; second training cycle - HIIT 2), and namely: Pre HIIT 1, 1 week-, 1.5 month- and 3 months-Post HIIT 1; and then similarly 1 week-, 1.5 month- and 3 months-Post HIIT 2. The subject from H-CO will be tested only once. To examine the assumed HIIT-induced changes in brain functioning the investigators will apply: (i) the positron emission tomography (PET), (ii) the functional magnetic resonance imaging (fMRI), (iii) electroencephalography (EEG) and (iv) an analysis of neurotrophic factors secretion level in blood. The investigators will also assess motor and non-motor symptoms of PD and psychomotor behaviors based on neuropsychological tests of cognitive functions and manual dexterity. The results of this project will help to answer the fundamental questions about HIIT induced mechanisms of neuroplasticity in PD patients, what is important from scientific and treatment-strategy point of view.

NCT04204551 Parkinson's Disease Physical Activity Neurorehabilitation Neuroplasticity
MeSH:Parkinson Disease

2 Interventions

Name: high-intensity interval training (HIIT)

Description: Two 12-week HIIT cycles will be divided with 3 months of break. Each HIIT cycle will consist of three 1-hour training sessions weekly. Each 1-hour training session will consist of 10-minutes warm-up (at slow voluntary speed), 40-minutes of interval exercise and 10-minutes cool-down phase. The interval exercise part will consist of 10 sets of 4 minutes interval including 2-minutes cycling at ≥ 60 [rpm], but preferably at 80-90 [rpm] (fast phase of interval) and 2-minutes cycling at ≤ 60 [rpm] (slow phase of interval). The training will be performed on a stationary cycle ergometer (MONARK, Ergomedic 874E, Sweden). The heart rate (HR, [bpm]) will be measured by Polar system (Polar, Finland). The patients will pedal on the cycloergometer at 60%-80% of their individualized HRmax.
Type: Behavioral
Group Labels: 1

PD-TR

Name: conventional physical therapy

Description: Conventional physical therapy as prescribed and provided by the National Health Fund of Poland, which includes activities for improving motor control, but without any kind of moderate or high intensity aerobic interval or continuous physical training (example: cycle ergometer, treadmill, or Nordic walking training)
Type: Behavioral
Group Labels: 2

PD-NTR PD-TR


Primary Outcomes

Description: To examine presynaptic striatal DA availability (in dorsal putamen) using PET imaging method with the 18F-dopa - [18F]fluorodopa uptake. The recordings will be expressed in Ki ref values [Ki ref] and Standard Uptake Values [SUV].

Measure: Positron Emission Tomography (PET) with 18F-dopa - PET imaging with [18F]fluorodopa uptake.

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: To examine presynaptic striatal DA availability (in dorsal putamen) using PET imaging method with the 18F-dopa - [18F]fluorodopa uptake. The recordings will be expressed in Ki ref values [Ki ref] and Standard Uptake Values [SUV].

Measure: Positron Emission Tomography (PET) with 18F-dopa - PET imaging with [18F]fluorodopa uptake.

Time: 1-week Post-HIIT 1

Description: To examine presynaptic striatal DA availability (in dorsal putamen) using PET imaging method with the 18F-dopa - [18F]fluorodopa uptake. The recordings will be expressed in Ki ref values [Ki ref] and Standard Uptake Values [SUV].

Measure: Positron Emission Tomography (PET) with 18F-dopa - PET imaging with [18F]fluorodopa uptake.

Time: 3-months Post-HIIT 2

Description: To evaluate neurophysiological functions of brain subcortical and cortical structures using MRI scanner. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The image recordings will express metabolic brain activity as expressed in fMRI response [% BOLD signal].

Measure: functional Magnetic Resonance Imaging (fMRI) - metabolic activity of brain recorded with MRI scanner.

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: To evaluate neurophysiological functions of brain subcortical and cortical structures using MRI scanner. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The image recordings will express metabolic brain activity as expressed in fMRI response [% BOLD signal].

Measure: functional Magnetic Resonance Imaging (fMRI) - metabolic activity of brain recorded with MRI scanner.

Time: 1-week Post-HIIT 1

Description: To evaluate neurophysiological functions of brain subcortical and cortical structures using MRI scanner. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The image recordings will express metabolic brain activity as expressed in fMRI response [% BOLD signal].

Measure: functional Magnetic Resonance Imaging (fMRI) - metabolic activity of brain recorded with MRI scanner.

Time: 3-months Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1-week Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1.5-month Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 3-months Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1-week Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1.5-month Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as an amplitude of event related potentials and expressed in microvolts [µV].

Measure: Electroencephalography (EEG) - amplitude of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 3-months Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1-week Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1.5-month Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 3-months Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1-week Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 1.5-month Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as a latency of event related potentials and expressed in milliseconds [ms].

Measure: Electroencephalography (EEG) - latency of EEG event related potentials of brain cortex recorded from scalp using surface electrodes.

Time: 3-months Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: 1-week Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: 1.5-month Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: 3-months Post-HIIT 1

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: 1-week Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: 1.5-month Post-HIIT 2

Description: To evaluate neurophysiological functions of brain cortical structures, electroencephalography (EEG - electrical activity of brain cortex) will be recorded from scalp using 128-chanel system. The recordings will be conducted at rest and during self initiated index finger motor task and during mental imagery of this motor task. The recordings will be analyzed as the EEG power in the beta-band (≈13-35 Hz) and expressed in decibels [dB].

Measure: Electroencephalography (EEG) - EEG power in the beta-band recorded from scalp using surface electrodes.

Time: 3-months Post-HIIT 2

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: 1-week Post-HIIT 1

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: 1.5-month Post-HIIT 1

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: 3-months Post-HIIT 1

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: 1-week Post-HIIT 2

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: 1.5-month Post-HIIT 2

Description: To evaluate neurophysiological functions of muscles engaged in an activity (hand muscles), electromyography (EMG - recordings of electrical activity of skeletal muscles) will be collected using surface electrodes, during index finger motor tasks and at rest. The recordings will be expressed in millivolts [mV].

Measure: Electromyography (EMG) - recordings of electrical activity of skeletal muscles using surface electrodes.

Time: 3-months Post-HIIT 2

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: 1-week Post-HIIT 1

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: 1.5-month Post-HIIT 1

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: 3-months Post-HIIT 1

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: 1-week Post-HIIT 2

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: 1.5-month Post-HIIT 2

Description: To evaluate executive function and bimanual dexterity. The Purdue Pegboard consists of a test board, score sheets and elements to work with: pins, collars, washers. Subjects are instructed to insert pins to holes in the board or build the sets with the elements in a fixed time. The final score is the number of pins inserted or built sets [number of pins or sets].

Measure: Purdue Pegboard Test (PPT) - neuropsychological test

Time: 3-months Post-HIIT 2

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: 1-week Post-HIIT 1

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: 1.5-month Post-HIIT 1

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: 3-months Post-HIIT 1

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: 1-week Post-HIIT 2

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: 1.5-month Post-HIIT 2

Description: TMT-A is a psychological measure of cognitive processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-A - trail making test, part A

Time: 3-months Post-HIIT 2

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT1 starts

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: 1-week Post-HIIT 1

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: 1.5-month Post-HIIT 1

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: 3-months Post-HIIT 1

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: 1-week Post-HIIT 2

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: 1.5-month Post-HIIT 2

Description: TMT-B is a psychological measure of executive function, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: TMT-B - trail making test, part B

Time: 3-months Post-HIIT 2

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: 1-week Post-HIIT 1

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: 1.5-month Post-HIIT 1

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: 3-months Post-HIIT 1

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: 1-week Post-HIIT 2

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: 1.5-month Post-HIIT 2

Description: ST-I is used as a psychological measure of processing speed, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-I - Stroop Test, part I

Time: 3-months Post-HIIT 2

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: 1-week Post-HIIT 1

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: 1.5-month Post-HIIT 1

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: 3-months Post-HIIT 1

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: 1-week Post-HIIT 2

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: 1.5-month Post-HIIT 2

Description: ST-II is used as a psychological measure of selective attention and inhibition, measured as performance time (the shorter the time the better performance), expressed in [s].

Measure: ST-II - Stroop Test, part II

Time: 3-months Post-HIIT 2

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: 1-week Post-HIIT 1

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: 1.5-month Post-HIIT 1

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: 3-months Post-HIIT 1

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: 1-week Post-HIIT 2

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: 1.5-month Post-HIIT 2

Description: Motor and non-motor Parkinson's disease signs/symptoms will be evaluated using UPDRS (sections I - III, that include the items 1 -31). Each item is expressed in [points] from 0 to 4 points, with an interpretation that the higher value means the severe accentuation of sign/symptom. The total score will be reported, as the sum of the points of the sections I-III (the score in the range 0 - 176 points) and each section's score will be reported as well, i.e.: the sum of the points of the section I (sum of points for items 1-4 in the range 0 - 16 points), the sum of the points of the section II (sum of points for items 5-17 in the range 0 - 52 points), the sum of the points of the section III (sum of points for items 18-31 in the range 0 - 108 points).

Measure: UPDRS - unified Parkinson's disease rating scale

Time: 3-months Post-HIIT 2

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: 1-week Post-HIIT 1

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: 1.5-month Post-HIIT 1

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: 3-months Post-HIIT 1

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: 1-week Post-HIIT 2

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: 1.5-month Post-HIIT 2

Description: BDNF secretion level in blood expressed in [pg/mL]

Measure: BDNF - brain derived neurotrophic factor

Time: 3-months Post-HIIT 2

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: 1-week Post-HIIT 1

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: 1.5-month Post-HIIT 1

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: 3-months Post-HIIT 1

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: 1-week Post-HIIT 2

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: 1.5-month Post-HIIT 2

Description: NGF secretion level in blood expressed in [pg/mL]

Measure: NGF - nerve growth factor

Time: 3-months Post-HIIT 2

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: 1-week Post-HIIT 1

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: 1.5-month Post-HIIT 1

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: 3-months Post-HIIT 1

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: 1-week Post-HIIT 2

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: 1.5-month Post-HIIT 2

Description: IGF 1 secretion level in blood expressed in [pg/mL]

Measure: IGF 1 - insulin-like growth factor 1

Time: 3-months Post-HIIT 2

Description: The single nucleotide polymorphism (SNP) BDNF Val66Met variant (rs 6265) will be genotyped by using the TaqMan SNP genotyping assay. Thermal cycling and end-point PCR (polymerase chain reaction) analysis will be performed on the Rotor-Gene Q 5plex real-time PCR Cycler and will be analyzed by Q-Rex-software. Genotype of BDNF polymorphism will be expressed in percentge values [% of genotype].

Measure: Val66Met polymorphism of BDNF - genotyping of BDNF polymorphism

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Secondary Outcomes

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: 1-week Post-HIIT 1

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: 1.5-month Post-HIIT 1

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: 3-months Post-HIIT 1

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: 1-week Post-HIIT 2

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: 1.5-month Post-HIIT 2

Description: Parkinson's disease stage evaluation using H&Y scale, expressed in [points] from 1 to 5 points. The modified version of the H&Y scale will be used, in which: the score 1 means - unilateral involvement only; the score 1.5 means - unilateral and axial involvement; the score 2 means - bilateral involvement without impairment of balance; the score 2.5 means - mild bilateral disease with recovery on pull test; the score 3 means - mild to moderate bilateral disease, some postural instability, physically independent; the score 4 means - severe disability, still able to walk or stand unassisted; the score 5 means - wheelchair bound or bedridden unless aided.

Measure: H&Y scale - Hoehn and Yahr scale

Time: 3-months Post-HIIT 2

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: 1-week Post-HIIT 1

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: 1.5-month Post-HIIT 1

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: 3-months Post-HIIT 1

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: 1-week Post-HIIT 2

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: 1.5-month Post-HIIT 2

Description: S&E DLA scale measure of daily function of Parkinson's disease patients, expressed in [%] from 100 to 0 % (with the higher % value as the better score). The 100% score means that the person is completely independent; able to do all chores without slowness, difficulty or impairment; essentially normal; unaware of any difficulty. The 0% score describes the person bedridden with the only vegetative functions such as swallowing; bladder and bowel functions are not functioning.

Measure: S&E DLA scale - Schwab and England Daily Living Activity Scale

Time: 3-months Post-HIIT 2

Description: MMSE will be used to to exclude the Parkinson's disease patients with cognitive impairment, expressed in [points]in the range from 0 to 30 points. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. A score of 23 or lower is indicative of cognitive impairment.

Measure: MMSE - Mini Mental State Examination

Time: Pre-HIIT 1 - it means up to 1-week before the HIIT 1 starts

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

Val66Met polymorphism of BDNF - genotyping of BDNF polymorphism. --- Val66Met ---

The single nucleotide polymorphism (SNP) BDNF Val66Met variant (rs 6265) will be genotyped by using the TaqMan SNP genotyping assay. --- Val66Met ---

The PD patients neuroplastic responsiveness to HIIT will be influenced by the BDNF polymorphism type, with potentially worse responsiveness for the Val66Met polymorphism of BDNF (this polymorphism causes a valine to methionine change at position 66 of the proBDNF protein). --- Val66Met ---

The investigators hypothesize that, the HIIT related increase of presynaptic DA availability will be significantly positively correlated with: (i) an improvement of NPFs and PMBs, and with an increased level of BDNF secretion in blood, and (ii) negatively with the BDNF Val66Met polymorphism type in PD-TR group. --- Val66Met ---



HPO Nodes