Exercise, Brain, and Cardiovascular Health (eBACH)
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|ClinicalTrials.gov Identifier: NCT03841669|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Aerobic Exercise Group Behavioral: Physical Activity & Health Information Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||150 individuals between the ages of 28 and 56 will be randomly assigned to one of two groups; Aerobic Exercise group or Physical Activity and Health Information group. The aerobic group will meet 2 times a week for 60 minutes over a 12-month period. Both groups will be asked to wear activity monitors every 6 weeks. Both groups will have fitness testing and cardiovascular assessments completed at baseline, 6 months and following the completion of the 12-month intervention.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Neither the investigator, nor outcomes assessors will know participants' group assignment. Participants will be instructed to refrain from speaking about their group's activities when visiting the lab for 6 month and follow-up assessments.In addition, special care was taken to ensure that non-blinded laboratory staff (i.e. staff member notifying participants of their group assignments, staff monitoring the intervention) are not located in the same proximity in the laboratory, further preventing accidental unblinding.|
|Primary Purpose:||Basic Science|
|Official Title:||Behavioral Studies of Cardiovascular Disease|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Aerobic Exercise Group
This is the experimental group. Supervised exercise will be held 2 times a week for 60 minutes and 1 time a week for 30 minutes at home.
Behavioral: Aerobic Exercise Group
Guidelines for exercise programming (ACSM, 2018) will be followed including a warm up and cool down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity related injury. The exercise group will receive moderate to vigorous intensity aerobic exercise for 60 minutes per day, twice a week, for 12 months. They will also exercise on their own for 30 minutes, 1 time a week, for 12 months. This gives a total of 3 exercise sessions a week. The prescribed intensity will be based on their maximal fitness testing heart rate and then calculated per a research grade method. They will maintain a minimum heart rate from their specific calculation that will be monitored by Polar Heart Rate straps.
Active Comparator: Physical Activity & Health Information Group
This is the control group. Participants will engage in daily life monitoring every 6 weeks.
Behavioral: Physical Activity & Health Information Group
This group will not partake in the aerobic fitness sessions but will be asked to wear a daily monitoring device every 6 weeks. They will also complete all baseline, 6-month, and 12-month visits.
- Change in Hippocampal Volume [ Time Frame: Baseline & 12 months ]Magnetic Resonance Imaging (MRI) will be used to measure the structure of the brain. Segmentation algorithms applied to structural MRI images will be used to compute the volume of the hippocampus in particular, which will be evaluated for change over the course of the trial.
- Change in systolic blood pressure responses to behavioral tasks [ Time Frame: Baseline & 12 months ]Average systolic blood pressure will be computed during a resting baseline period and during the performance of two behavioral tasks, (1) a Stroop color-word interference task and (2) a multi-source interference task. Mean baseline levels of systolic blood pressure will be subtracted from mean levels averaged across the two tasks to compute response scores, and changes in task-response scores will be evaluated over the course of the trial.
- Change in Heart Rate Variability (HRV) [ Time Frame: Baseline & 12 months ]Heart rate variability will be computed from inter-beat intervals derived from electrocardiographic recordings while participants rest in the seated position. Average heart rate variability values from the recording period will be assessed for their change over the trial.
- Change in daily life Ecological Monitoring Assessment (EMA) [ Time Frame: Baseline & 12 months ]Participants will complete several questions on a smart phone at various times throughout the day based on a prompt to learn more about positive and negative affect. An average positive and negative affect score will be computed.
- Change in Blood pressure [ Time Frame: Baseline, 6-month, & 12 months ]An average systolic blood pressure (SBP) and heart rate will be calculated for an average over all baseline, 6-month and 12-month visits.
- Change in daily life SBP reactivity [ Time Frame: Baseline & 12 months ]Participants will have their blood pressure taken while answering questions about daily stressors and an average SBP score will be computed over the course of the wear period.
- Change in negative and positive affect [ Time Frame: Baseline & 12 months ]This will be calculated via scores from the Positive and Negative Affect Scale. Scores can range from 1 to 100, with 1 meaning less positive affect and 100 meaning more positive affect.
- Change in baroreflex sensitivity (BRS) [ Time Frame: Baseline & 12 months ]Participants will have electrodes placed on their skin to record an EKG as well as a blood pressure cuff on their arm. BRS will be derived in part from the EKG signal.
- Change in pulse wave velocity (PWV) [ Time Frame: Baseline & 12 months ]Participants will have electrodes placed on their skin to record an EKG as well as a blood pressure cuff on their arm. PWV will be derived in part from the EKG signal.
- Change in vasodilation (reactive hyperemia) [ Time Frame: Baseline & 12 months ]Participants will have electrodes placed on their skin to record an EKG as well as a blood pressure cuff on their arm. Vasodilation (reactive hyperemia) will be derived in part from the EKG signal.
- Change in Cardiorespiratory fitness [ Time Frame: Baseline, 6-month, & 12-month ]Fitness is assessed by maximal graded exercise testing. Oxygen uptake (VO2) will be measured from expired air samples taken at 15s intervals until a peak VO2, the highest VO2, is attained at the point of test termination due to symptom limitation and/or volitional exhaustion.
- Change in brain activity [ Time Frame: Baseline & 12 months ]MRI will be used to measure changes in brain activity including task invoked activation patterns.
- Change in Resting state connectivity [ Time Frame: Baseline & 12 months ]MRI will be used to measure changes in functional connectivity during rest.
- Change in Cortical thickness. [ Time Frame: Baseline & 12 months ]MRI will be used to measure cortical thickness. Measured in mm3.
- Change in Cortical volume. [ Time Frame: Baseline & 12 months ]MRI will be used to measure cortical volume. Measured in mm3.
- Change in Insulin resistance. [ Time Frame: Baseline, 6-month & 12 month ]Blood will be drawn at 3 time points throughout the intervention starting at baseline to measure changes in insulin resistance.
- Change in fasting glucose. [ Time Frame: Baseline, 6-month & 12 month ]Blood will be drawn at 3 time points throughout the intervention starting at baseline to measure changes in fasting glucose.
- Mediation [ Time Frame: Baseline, 6 month, and 12 month. ]The outcome will be measured by whether the statistical mediation model that contains brain and peripheral physiological mediators is significant. By definition such a model must contain multiple outcome variables, but the outcome here isn't a measurable outcome but rather whether the statistical model with these variables reaches statistical significance.
- Change in fMRI [ Time Frame: Baseline & 12 months ]Changes in task invoked activity will be measured during an emotion regulation task.
- Change in white matter measures [ Time Frame: Baseline & 12 months ]MRI will be used to measure brain morphology including white matter structure and lesions.
- Change in reappraisal and suppression scores [ Time Frame: Baseline, 6-month & 12 months ]Participants will complete the Emotion Regulation Questionnaire (ERQ). They rate how strongly they agree with 10 statements and emotion regulation abilities are calculated by their responses. A minimum score would be 10 and a maximum score would be 70, with 70 indicating superior emotion regulation abilities.
- Change in Perceived Stress Scale (PSS) [ Time Frame: Baseline, 6-month & 12 months ]This will be calculated via the PSS 4-item scale. Scores are calculated by averaging responses from 10 questions with a minimum score of 0 and a maximum score of 40. 40 indicates more stress.
- Change in Self-esteem [ Time Frame: Baseline, 6-month & 12 months ]Participants will complete a questionnaire related to self-esteem via the Rosenberg Self Esteem Scale. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. Sum scores for all 10 items are calculated with items 2, 5, 6, 8, 9 being reverse scored. Higher scores indicate higher self-esteem.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841669
|Contact: Mary E Crisafio, MSfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Mary Crisafio, MS 412-624-4556 email@example.com|
|Sub-Investigator: Chaeryon Kang, PhD|
|Sub-Investigator: Matthew F Muldoon, MD|
|Principal Investigator:||Kirk I Erickson, PhD||University of Pittsburgh|
|Principal Investigator:||Peter Gianaros, PhD||University of Pittsburgh|