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Report for Clinical Trial NCT02230267

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease

Several animal and human epidemiologic studies have provided evidence that exercise may be neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the case of those who have already been diagnosed with PD, it may slow the observed neurodegeneration. Unfortunately, because this line of research is in early stages, there is little evidence to indicate what biological mechanisms underlie the neuroprotection that is conferred with exercise. Toward this end, it is possible that an interaction between endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be associated with exercise improvements in PD. One of the most common reasons for premature death in PD is falls. Several meta-analyses have concluded that exercise training programs focused on balance and/or strength training are effective at improving aspects of balance. Taken together, the current body of evidence suggests that exercise may be neuroprotective and balance/strength training may decrease the likelihood of a fall. The combination of these efficacious treatment modalities (exercise and balance/strength training) in a comprehensive treatment approach to improve PD symptoms and balance has been previously reported at relatively mild or moderate exercise intensities. Because recent research has suggested that patients with PD may benefit more from more physically intense programs, we are proposing a more aggressive approach with regard to exercise intensity and frequency in the present trial. The primary purpose of this study is to determine the feasibility and safety of a high intensity exercise approach to PD. A secondary purpose is to determine the trajectory of change in outcomes over the duration of the trial from a high intensity fall prevention program. It is hoped that a signal of efficacy will allow this trial to progress to a comparative effectiveness trial. An important innovative design element is collecting biological assays to better understand the mechanism underlying the anticipated clinical improvements. Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers for Disease Control exercise standards (150 min/wk moderate level aerobic exercise; strengthening at least two times per week) for the duration of the trial. Aim 2 is to determine if participation in an 8-week HIBC under the direction of a physical therapist is safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week HIBC will produce a signal of efficacy for several physical outcomes: falls per physical activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health, cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an 8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of BDNF val66val, val66met, met66met polymorphisms to determine if there is a differential response to exercise. This trial is innovative because it utilizes a high intensity comprehensive exercise treatment approach (aerobic exercise, strengthening, and balance training). To our knowledge, there have been no trials of individuals with PD who have participated in a trial of this intensity in a group "boot camp" setting. Another innovative design element is the use of three novel assessments: biological assays of pro- and anti-inflammatory cytokines, endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity ratio). Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual care control group (standard, low intensity group therapy class) under the direction of physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be required to attend 3 out of the 5 days. The protocol of the HIBC will include the following exercise components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15 minutes of strengthening the major muscle groups; C. 15 minutes of balance training; and, D. 15 minutes of interspersed rest and stretching. Participants will rotate through these four exercise components. Participants will have one baseline test and assessments at the 2-week, 4 week, 8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be frequency counts of participation, adverse events, and compliance with exercise. The outcomes for the secondary aims will include measures of balance and falls, physical capacity, fatigue, exercise/physical activity behavior, and biological assays.

NCT02230267 Parkinson's Disease
MeSH: Parkinson Disease

2 Interventions

Name: High intensity exercise and balance training

Type: Other

High intensity boot camp

Name: Usual care arm exercise

Type: Other

Usual care arm


Primary Outcomes

Description: The number of participants that attend and participate in the treatment at least 3 times per week for 8 weeks.

Measure: Frequency feasibility

Time: After completion of the 8 week trial

Description: The number of participants that complete at least 150 minutes per week of moderate intensity exercise (70%+ of their estimated HR maximum). This will be ascertained using heart rate monitors.

Measure: Aerobic feasibility

Time: At the end of the 8 week trial

Description: The number of participants that participate in strengthening exercises that incorporates all the major muscle groups at least two days per week.

Measure: Strength feasibility

Time: At the end of the 8 week trial

Description: Drop-out rate and reason for drop-out will be tracked.

Measure: Compliance

Time: At the end of the 8 week trial

Description: Exercise-related adverse events (e.g., strains/sprains, cardiovascular events).

Measure: Safety

Time: Ongoing throughout the 8 week trial

Description: The Intrinsic Motivation Inventory (IMI) will be used to gather information about motivation.

Measure: Motivation

Time: At 8 weeks

Description: Falls and fall injuries in and out of boot camp will be collected.

Measure: Falls

Time: At the end of the 8 week trial

Secondary Outcomes

Description: Falls will be tracked for 6 months after the boot camp using a falls diary. A member of the research team will call each month to interview participants about their falls. We will assess falls/fall injuries per physical activity ratio during the 6 month period following the trial and time to a fall/fall injury after the trial.

Measure: Falls

Time: up to 6 months

Description: Physical activity will be assessed using the Physical Activity Monitoring System (PAMsys).

Measure: Motor activity

Time: up to 6 months

Description: Fatigue will be assessed using the Parkinson Fatigue Scale (PFS).

Measure: Fatigue

Time: up to 6 months

Description: This will be assessed functionally using the 30 second Sit-To-Stand Test (30STS) for muscle strength.

Measure: Strength

Time: up to 6 months

Description: Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).

Measure: Cognition

Time: up to 6 months

Description: This will be assessed by using a measure of disease-specific quality of life (Parkinson's Disease Questionnaire-39 (PDQ39)).

Measure: Quality of life

Time: up to 6 months

Description: All participants will track their participation in exercise and physical activity using an exercise diary for 6 months following the boot camp. Participants will be called monthly to reinforce completion of the exercise diary.

Measure: Long term behavioral change

Time: up to 6 months

Description: Performance-based balance tasks.

Measure: mini-Balance Evaluation Systems Test (mini-BESTest)

Time: up to 6 months

Description: Activities Specific Balance Confidence Scale (ABC)

Measure: Falls self-efficacy

Time: up to 6 months

Description: Self-report measurement tool: Falls Efficacy Scale (FES)

Measure: Fall Efficacy

Time: Up to 6 months

Description: Self-report of fall catastrophization: Catastrophization about Falls Questionnaire (CAFS)

Measure: Fall catastrophization

Time: Up to 6 months

Description: Self-report measure physical activity: International Physical Activity Questionnaire (IPAQ)

Measure: Physical activity

Time: Up to 6 months

Description: Unified Parkinson's Disease Rating Scale motor subscale (UDPRS III)

Measure: Motor symptoms

Time: Up to 6 months

Description: Self-report scale of avoidance behavior due to a fear of falling: Fear of Falls Avoidance Behavior Questionnaire (FFABQ)

Measure: Fear of falling

Time: Up to 6 months

Description: Endurance will be assessed using the 6 Minute Walk Test (6MWT).

Measure: Endurance

Time: Up to 6 months

Description: Bone health will be measured using bone mineral densiometry (BMD).

Measure: bone health

Time: up to 6 months

Description: Mood will be measured using the Beck Depression Inventory.

Measure: Mood

Time: up to 6 months

Description: Catalase concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.

Measure: Catalase

Time: Up to 6 months

Description: Cytokine (TNF╬▒, IL-6, IL-10) concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.

Measure: Cytokines

Time: Up to 6 months

Other Outcomes

Description: Circulating BDNF concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.

Measure: BDNF

Time: up to 6 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

An additional exploratory aim will be an analysis of BDNF val66val, val66met, met66met polymorphisms to determine if there is a differential response to exercise. --- val66met ---



HPO Nodes