Exercise, Brain, and Cardiovascular Health (eBACH)

  • STATUS
    Recruiting
  • End date
    Jun 5, 2023
  • participants needed
    150
  • sponsor
    University of Pittsburgh
Updated on 12 February 2022
Accepts healthy volunteers

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.

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.

Details
Condition Cardiovascular Diseases
Treatment Aerobic Exercise Group, Physical Activity & Health Information Group
Clinical Study IdentifierNCT03841669
SponsorUniversity of Pittsburgh
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age - individuals aged 26-58 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 100 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 (SSRIs are permitted)
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 (if applicable) 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 160/100)
>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
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)
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