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Aerobic Exercise for Cardiovascular Health (eBACH Trial)
N/A
Waitlist Available
Led By Peter Gianaros, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age - individuals aged 26-58 years old
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-month (if applicable) & 12 month
Awards & highlights
eBACH Trial Summary
This trial will study the effects of aerobic exercise on brain structure and function, as well as how these changes relate to cardiovascular function.
Who is the study for?
The eBACH study is for adults aged 26-58 who are relatively inactive, exercising less than 100 minutes per week, with a VO2max below the 75th percentile. Participants must be able to walk unaided and live in Pittsburgh for at least one year post-randomization. They should be willing to be randomly assigned to an intervention group and have reliable transportation.Check my eligibility
What is being tested?
This trial tests how aerobic exercise affects brain structure/function and its relationship with cardiovascular health. Participants will either join a Physical Activity & Health Information Group or an Aerobic Exercise Group, determined by random assignment.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include typical exercise-related issues such as muscle soreness, fatigue, joint pain or injury risk. The intensity of these side effects can vary from person to person.
eBACH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 26 and 58 years old.
Select...
I can walk without pain or help from devices.
eBACH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6-month (if applicable) & 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-month (if applicable) & 12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Heart Rate Variability (HRV)
Change in Hippocampal Volume
Change in systolic blood pressure responses to behavioral tasks
Secondary outcome measures
Change in Cortical thickness.
Change in Cortical volume.
Change in Resting state connectivity
+7 moreOther outcome measures
Change in Blood pressure
Change in Cardiorespiratory fitness
Change in Heart Rate
+7 moreeBACH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic Exercise GroupExperimental Treatment1 Intervention
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.
Group II: Physical Activity & Health Information GroupActive Control1 Intervention
This is the control group. Participants will engage in daily life monitoring every 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise Group
2010
N/A
~220
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,458 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,366 Total Patients Enrolled
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,211 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am open to being assigned to any treatment group in the study.I use medication at least 3 times a week for my lung condition, but rescue inhalers are fine.I have type 2 diabetes and am on insulin or two or more diabetes medications.I haven't had cancer treatment in the last year, except for non-melanoma skin cancer.I am of any gender or ethnicity.My blood pressure is not higher than 160/100.I am between 26 and 58 years old.I have never had a heart attack, stroke, or any major heart-related surgeries.I do not take prescribed blood pressure medication regularly.I live in Pittsburgh and plan to stay for the next year. I have reliable transportation.I have Type 1 diabetes or I am on insulin treatment.I do not regularly use psychotropic medications, except for SSRIs.I do not have chronic kidney failure, have not had dialysis or a kidney transplant.I am not pregnant and do not plan to become pregnant in the next year.I can walk without pain or help from devices.I have never had hepatitis B or C, liver failure, or cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: Aerobic Exercise Group
- Group 2: Physical Activity & Health Information Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people over the age of 30 being accepted into this clinical trial?
"In order to be included in this study, applicants must be between 26-58 years old. Out of the 385 clinical trials conducted, only 28 included patients that were under 18."
Answered by AI
Are we still enrolling test subjects for this experiment?
"Yes, the information on clinicaltrials.gov says that this clinical trial is presently looking for candidates. The clinical trial was initially posted on 5/15/2019 and was most recently updated on 10/28/2021. The trial is recruiting for 150 participants at 1 locations."
Answered by AI
What are researchers hoping to discover by conducting this clinical trial?
"This clinical trial will aim to observe changes in systolic blood pressure responses to behavioural tasks over a period of 12 months. Additionally, researchers will also look for changes in brain activity (using MRI to measure task-invoked activation patterns), baroreflex sensitivity (BRS;recorded via EKG and blood pressure cuff), and vasodilation (reactive hyperemia; recorded via EKG and blood pressure cuff)."
Answered by AI
Who would be the best candidate to take part in this research?
"This study is looking for 150 participants who have cardiovascular diseases and are aged between 26 and 58. Additional requirements include that they exercise for less than 100 minutes per week, have a VO2max percentile level below 75, and be willing to be randomized to either of the intervention arms. Furthermore, participants must be able to walk without pain, live in the Pittsburgh area, and have reliable transportation."
Answered by AI
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