Exercise, Brain, and Cardiovascular Health

NCT03841669 | Completed Results DMC

• 2 other identifiers: STUDY19020218P01HL040962
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Brain; Cardiovascular Disease; Exercise; Brain Health

Outcome Measures

Primary Outcomes (1)

• Change in Hippocampal Volume

  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.

  Baseline & 12 months

Secondary Outcomes (2)

• Change in Systolic Blood Pressure Responses to Behavioral Tasks

  Baseline & 12 months

• Change in Heart Rate Variability (HRV)

  Baseline & 12 months

Other Outcomes (20)

• Change in fMRI

  Baseline & 12 months

• Change in Reappraisal and Suppression Scores

  Baseline, 6-month (if applicable) & 12 months

• Change in Perceived Stress Scale (PSS)

  Baseline, 6-month (if applicable) & 12 months

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

This is the experimental group. Exercise is prescribed for 150 min/week. Due to COVID-19 restrictions the exercise supervision was allowed to be either remotely or in the context of a laboratory setting.

Behavioral: Aerobic Exercise Group

Physical Activity & Health Information Group

ACTIVE COMPARATOR

This is the control group. Participants will engage in daily life monitoring every 6 weeks.

Behavioral: Physical Activity & Health Information Group

Interventions

Aerobic Exercise Group BEHAVIORAL

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 targeting 150 minutes per week for 12 months. The group will target dividing these minutes into 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.

Aerobic Exercise Group

Physical Activity & Health Information Group BEHAVIORAL

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 (optional), and 12-month visits.

Physical Activity & Health Information Group

Eligibility Criteria

• Age: 26 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (9th and 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Molina Hidalgo C, Collins AM, Crisafio ME, Grove G, Kamarck TW, Kang C, Leckie RL, MacDonald M, Manuck SB, Marsland AL, Muldoon MF, Rasero J, Scudder MR, Velazquez-Diaz D, Verstynen T, Wan L, Gianaros PJ, Erickson KI. Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial. BMJ Open. 2023 Nov 15;13(11):e077905. doi: 10.1136/bmjopen-2023-077905.

  PMID: 37968003 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Kirk I. Erickson
• Organization: AdventHealth Research Institute

Kirk.Erickson@adventhealth.com

4125763724

Study Officials

• Kirk I Erickson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Peter Gianaros, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 (if applicable) 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 130 individuals between the ages of 26 and 58 will be randomly assigned to one of two groups; Aerobic Exercise group or Physical Activity and Health Information group. The exercise group will receive moderate to vigorous intensity aerobic exercise targeting 150 minutes per week for 12 months. The group will target dividing these minutes into 3 exercise sessions a week 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 (optional) and following the completion of the 12-month intervention.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 15, 2019
• Study Start: May 15, 2019
• Primary Completion: February 3, 2024
• Study Completion: February 15, 2024
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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.

Locations

US (1)