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HEART-PLAY Exercise Program for Cardiovascular Disease (HEART-PLAY Trial)
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, and 12 months
Awards & highlights
HEART-PLAY Trial Summary
This trial is testing whether a peer-led program can help people with cardiovascular disease stick to an exercise routine. The program includes 36 sessions of cardiovascular rehabilitation, as well as peer and staff leadership, self-monitoring tools and feedback, group education and materials, and motivational, goal-setting, and relapse prevention counseling sessions. The goal is to see if the program can help people stick to an exercise routine of 150 minutes per week.
Who is the study for?
This trial is for men and women over 18 with cardiovascular disease who've been referred to a specific cardiac rehab program. They must understand English, be able to consent, complete surveys, not have had serious falls recently, and can do light exercise. People with severe lung issues, recent strokes or major depression, unmanaged angina or those post certain heart procedures aren't eligible.Check my eligibility
What is being tested?
The HEART-PLAY study tests if a peer-led exercise program improves long-term workout habits in people with heart conditions compared to standard cardiac rehab alone. Participants will attend 36 sessions over about three months and get extra support like self-monitoring tools and motivational counseling in the HEART-PLAY group.See study design
What are the potential side effects?
Since this trial focuses on exercise adherence rather than medication or invasive treatments, side effects are minimal but may include typical exercise-related risks such as muscle soreness or strain.
HEART-PLAY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Minutes of Moderate Physical Activity (PA)
Secondary outcome measures
Change in BNP levels
Change in Galectin-3 levels
Change in Health-related quality of life (QoL)
+1 moreHEART-PLAY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HEART-PLAYExperimental Treatment1 Intervention
Participants in the HEART-PLAY will receive standard CR and additionally receive pedometers, resistance bands, and the National Institute of Aging (NIA) exercise guide. They will further receive counseling from peer health coaches, social support from group education sessions, and supplemental educational materials. After the 12 weeks of prescribed, supervised exercise sessions, HEART-PLAY group participants will continue to receive support from peers and clinic staff with check-in calls, feedback on pedometer goals, and twice weekly group events including walks and/or resistance band group exercise classes.
Group II: Standard Cardiac RehabilitationActive Control1 Intervention
Participants in the STANDARD condition will receive the standard of care cardiac rehabilitation, consisting of 36 sessions across 12 weeks of prescribed, supervised exercise sessions.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,112 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have recently had a stroke or other serious brain-related issue that would prevent you from participating in the study.You have chest pain (angina) that doesn't get better with nitrate medication.You are able to do some physical activity that is not too strenuous.
Research Study Groups:
This trial has the following groups:- Group 1: HEART-PLAY
- Group 2: Standard Cardiac Rehabilitation
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.
Is there still capacity for individuals to partake in this research?
"Per information provided on the clinicaltrials.gov platform, this medical trial is not currently enrolling patients. It debuted August 22nd 2018 and was last updated April 8th 2021; yet, there are 415 other studies actively seeking participants at present."
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