Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. This research will be the first to examine the independent and combined effects of a lifestyle physical activity intervention and cognitive training on memory performance and memory-related serum biomarkers in this vulnerable population. The investigators will incorporate a practical lifestyle approach that can be delivered in the home and community settings to prevent or delay memory loss in older women with CVD.
Name: Mind
Name: Move
Description: The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance.
Measure: Change in East Boston Memory Test scores from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance.
Measure: Change in Category Fluency Test scores from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance.
Measure: Change in Digit Span Forwards and Backwards Test scores from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. Possible minimum score is "discontinued" due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance.
Measure: Change in Oral Trails A/B tests scores from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance.
Measure: Change in Digit Ordering Tests scores from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: We will obtain blood samples for BDNF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Measure: Change in brain-derived neurotrophic factor (BDNF) levels from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: We will obtain blood samples for VEGF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Measure: Change in vascular endothelial growth factor A (VEGF) levels from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: We will obtain blood samples for IGF-1. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Measure: Change in insulin-like growth factor 1 (IGF-1) from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as "counts." Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (< 3 METS [metabolic equivalent of task]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). We will report findings in mean daily minutes of each intensity of physical activity.
Measure: Change in GT3XE-Plus Triaxial Accelerometer activity minutes (light and moderate vigorous physical activity) from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: This is a test of aerobic fitness that can be performed in a small space using minimal equipment. Participants step in place to a predesignated height for two minutes. This test is correlated with treadmill tests of aerobic fitness.
Measure: Change in the two-minute step test of aerobic fitness score from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: The Community Health Activities Model Program for Seniors (CHAMPS) is a 30-item self-report questionnaire that assesses the leisure time, household, and transportation physical activity in past two weeks. Participants are asked how long they participate in 30 different activities and at what frequency. Each activity is assigned intensity. Scores include mean minutes per week of light and moderate-vigorous physical activity for both leisure time and household scales (minimum score of 0 minutes and maximum score of 24 hours, with higher scores indicating more time spent in physical activity).
Measure: Change in self-reported physical activity as assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) survey from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: Self-report cognitive activity is a self-report questionnaire of participation in seven activities that involve information processing with minimal physical or social demands. Participants rate on a five-point scale. The score is an average of nine items (minimum score of 9, maximum score of 54 with higher scores indicating higher self-reported levels of cognitive activity).
Measure: Change in self-reported cognitive activity from baseline to 24 weeks, 48 weeks, and 72 weeks Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: Depressive symptoms will be evaluated as a potential moderator. The Center for Epidemiologic Studies-Depression Scale (20 items scored 0-3) assesses symptoms of depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Participants who score ≥ 16 will be referred to their primary/ psychiatric provider for further evaluation and treatment. Scores range from 0-60, with higher score indicating more depressive symptoms.
Measure: Level and change in Center for Epidemiologic Studies-Depression Scale score from baseline to 24 weeks, 48 weeks, and 72 weeks. Time: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDescription: Potential moderator. Candidate gene analysis with DNA extraction from whole blood samples using an Autogen DNA isolation kit (Qiagen, Venlo, Netherlands). Participants will be characterized by APOE genotype and subdivided into two groups of patients in whom the APOE ε4 allele was absent or present.
Measure: Apolipoprotein [APOE]- ε4 allele Time: BaselineDescription: Potential moderator. Val66Met polymorphism in the BDNF gene assessed using candidate genotyping. The BDNF gene locus is located on Chromosome 11. BDNF Met positive genotypes are heterozygous Val/Met or homozygous Met/Met.
Measure: Brain-derived neurotrophic factor (BDNF) Val66Met polymorphism Time: BaselineAllocation: Randomized
Factorial Assignment
There is one SNP
Participants will be characterized by APOE genotype and subdivided into two groups of patients in whom the APOE ε4 allele was absent or present.. Brain-derived neurotrophic factor (BDNF) Val66Met polymorphism. --- Val66Met ---
Val66Met polymorphism in the BDNF gene assessed using candidate genotyping. --- Val66Met ---