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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
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kirk Erickson, PhD, University of Pittsburgh

Brief Summary:
eBACH is a randomized intervention to determine the effects of aerobic exercise on brain structure and function, as well as to determine how exercise-induced training effects relate to cardiovascular function via related brain changes.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Aerobic Exercise Group Behavioral: Physical Activity & Health Information Group Not Applicable

Detailed Description:
Aim 1: To determine the neurobiology of exercise and cardiovascular factors: (1A) Body- to -Brain hypothesis: Exercise -induced changes in peripheral markers of cardiovascular health (e.g., cardiorespiratory fitness, peripheral vascular function) will precede and partly explain (statistically mediate) some of the exercise -induced changes in functional and structural features of areas defining visceral control circuits. (1B) Brain- to -Body hypothesis: Exercise -induced changes in functional and structural features of areas defining visceral control circuits precede and partly explain (statistically mediate) consequent changes in autonomic and neuroendocrine mediators of cardiovascular function that are under neural regulation, including baro-reflex sensitivity and heart rate variability. Aim 2: To determine the neurobiology of exercise self--reported correlates of cardiovascular function: (2A) Exercise will induce changes in visceral control areas engaged by functional magnetic resonance imaging (fMRI) tasks, and these changes will partly explain exercise- induced reductions in cardiovascular responsivity to challenges in daily life. (2B) Exercise will induce changes in visceral control areas engaged by an functional magnetic resonance imaging (fMRI) emotion processing and regulation paradigm, and these changes will partly explain exercise- induced improvements in affect measured in daily life by EMA and by conventional self- report instruments. The public health significance of this research is that it is designed to more precisely define and refine neurobiological targets to improve cardiovascular function and health.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Change in brain activity [ Time Frame: Baseline & 12 months ]
    MRI will be used to measure changes in brain activity including task invoked activation patterns.

  10. Change in Resting state connectivity [ Time Frame: Baseline & 12 months ]
    MRI will be used to measure changes in functional connectivity during rest.

  11. Change in Cortical thickness. [ Time Frame: Baseline & 12 months ]
    MRI will be used to measure cortical thickness. Measured in mm3.

  12. Change in Cortical volume. [ Time Frame: Baseline & 12 months ]
    MRI will be used to measure cortical volume. Measured in mm3.

  13. 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.

  14. 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.

  15. 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.


Other Outcome Measures:
  1. Change in fMRI [ Time Frame: Baseline & 12 months ]
    Changes in task invoked activity will be measured during an emotion regulation task.

  2. Change in white matter measures [ Time Frame: Baseline & 12 months ]
    MRI will be used to measure brain morphology including white matter structure and lesions.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   28 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age - individuals aged 28-56 years old
  • Gender & Ethnicity - men and women are both eligible to participate. The eBACH study expects the study population to be approximately 50% women. All ethnic groups are eligible for the study. The eBACH study expects the study population to be approximately 30% minorities.
  • Ambulation - study participants must be able to walk without pain or use of an assisted walking device. This will be determined during the initial phone screen. Ambulation will also be assessed in person as the potential subject must be able to complete the VO2 Max test on a treadmill.
  • Physical Activity Level - all participants must exercise less than 75 minutes per week and have a VO2max percentile level less than 75 based on the ACSM Guidelines for Exercise Testing (10th edition).
  • Residency - Since the intervention is 12 months in duration, all potential participants must reside in the Pittsburgh area and plan on residing in the area for at least one year after randomization. It is recommended that the study coordinator during the second screen assess potential participants' distance from the exercising sites since the study requires 2 visits per week. The further a participant is from an intervention site, the higher the probability they will be unable to adhere to the protocol. In addition, participants must have reliable transportation to complete the outcome measures and the intervention requirements. Questions related to these considerations are asked during the phone screen and should also be assessed during the baseline visits.
  • Willingness to be randomized - To be eligible, all potential study participants must be willing to be randomized to either of the intervention arms. Individuals that insist on participating only if they can choose which arm they belong to should not be enrolled.

Exclusion Criteria:

  • Current use of prescribed blood pressure medication - participants who regularly use blood pressure medication will be excluded from the study.
  • Self-reported chronic psychotic illness (schizophrenia, bipolar disorder) or neurological disorder (Parkinson's disease, dementia, MCI) - the eBACH study will exclude anyone who self-reports that they experience schizophrenia, bipolar disorder or parkinson's, dementia, or mild cognitive impairment.

    • Regular use of psychotropic medications - participants who regularly use psychotropic medications is defined as taking more than 7 times in a two week period will be excluded from the study.
  • Current pregnancy or plans to become pregnant over the next year - any woman who is pregnant via the pregnancy test at the baseline visit will be excluded from the study. A pregnancy test will also be given at the MRI visit and this will be repeated at 6-months and 12-months.
  • Self-reported prior heart attack, stroke, bypass surgery, angioplasty, congestive heart failure, arrhythmia (cardiac rhythm problems) - any person that reports that they have any of the health conditions listed above will be excluded from the study.
  • Severe hypertension (sbp/dbp greater than/or equal to 160/110)

    • >140/90 IS ALLOWED, but feedback card and information about elevated levels will be provided to the participant.
  • Cancer - potential participants who have received treatment in the last 12 months for cancer, including radiation or chemotherapy will be excluded from the study. Although, if a potential participant who had non-melanoma skin cancer will be allowed to enroll in eBACH.
  • Liver disease - any person who has had hepatitis B or C, liver failure or Cirrhosis will be excluded from the study.
  • Kidney disease - potential participants who indicated they have chronic kidney failure, have undergone dialysis, or have had a kidney transplant will not be eligible to participant in the eBACH study.
  • Type 1 diabetes and/or insulin treatment

    • Type 2 diabetics if they are taking insulin or 2 or more diabetes medications. Single injections that contain 2+ drugs count as 2 medications.
  • Lung disease requiring drug treatment (any medication usage 3x/week in the last 2 weeks for chronic obstructive pulmonary disease (COPD), emphysema, asthma)

    • Rescue inhalers are okay.
  • Non fluency in english - speaking/reading English everyday for <10 years
  • Nightshift work - the eBACH study for the purposes of the EMA monitoring will exclude any participants who work more than 12 night shifts in the last year, or participants who work more than one night shift per month on average. This is defined as a period of work in which half or more of the hours worked are between midnight and 8:00 in the morning.
  • Mri incompatable

    • Claustrophobia - fear of enclosed or confined spaces
    • Certain medical devices, implants or other metal objects in or on the body that cannot be removed and are mr incompatible
    • Inability to fit into the mri scanner
    • Colorblindness
    • History of injury with metal object, metal in eye, welding or working in close proximity to welding without xray to prove lack of metal in body.
  • Suspected alcohol use disorder - for the eBACH study alcohol use disorder is defined as having five or more drinks at one time three times or more per week.
  • Those who are otherwise unable to meet the requirements of the study (persons whose employment or personal situation will not permit momentary interruptions required for electronic diary and ambulatory data)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841669


Contacts
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Contact: Mary E Crisafio, MS 412-624-4556 mcrisafio@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Mary Crisafio, MS    412-624-4556    mcrisafio@pitt.edu   
Sub-Investigator: Chaeryon Kang, PhD         
Sub-Investigator: Matthew F Muldoon, MD         
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Kirk I Erickson, PhD University of Pittsburgh
Principal Investigator: Peter Gianaros, PhD University of Pittsburgh

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Responsible Party: Kirk Erickson, PhD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03841669     History of Changes
Other Study ID Numbers: P01HL040962 ( U.S. NIH Grant/Contract )
P01HL040962 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data from this study will be made available to outside investigators under a data-sharing agreement. The data will be available to outside investigators after publication of the primary aims and at completion of quality control assessments and data organization. The investigators expect that the data from this study will result in interest from internal and external investigators for secondary analysis and ancillary projects.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Will be made available after study investigators have published summary data and primary aims results. Will be available for unlimited amount of time.
Access Criteria: Data requests will be approved by the PI and Co-PI. Requests can be made by contacting the study coordinator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kirk Erickson, PhD, University of Pittsburgh:
Brain
Cardiovascular Disease
Exercise
Brain Health

Additional relevant MeSH terms:
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Cardiovascular Diseases