Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
United States320 participantsStarted 2023-08-10
Plain-language summary
The goal of this clinical trial is to compare two types of exercise prescriptions in cardiac rehabilitation eligible older adults (60 years or older) with heart disease. The investigators found in a single site pilot trial (insert NCTxxx) that one exercise prescription was better and are now repeating this study in a larger population at two sites (Baystate Medical Center, Springfield MA and Henry Ford Health System, Detroit MI). The main questions the investigators aim to answer are:
1. Compare two different exercise prescriptions in cardiac rehabilitation on exercise outcomes
1. Graded exercise test +Target heart rate range prescription \[GXT-THRR\]
2. Rating of perceived exertion (RPE)
2. What is the role of psychological feedback on fitness outcomes during cardiac rehabilitation and physical activity outside of cardiac rehabilitation.
3. What are the long-term clinical outcomes between the two exercise prescriptions
Participants will be asked to:
* Complete surveys about physical activity, exercise anxiety, exercise efficacy, and fears about exercising
* Perform fitness measures (6-minute walk test, balance tests, stand to sit tests, a 400 meter walk, and handgrip strength)
* Attend at least 18 sessions of cardiac rehabilitation after they are randomized to their exercise prescription group
* Wear a heart rate monitor and a physical activity monitor per study protocol
Participants will be randomized (flip of a coin) to either receive a graded exercise test and psychoeducational feedback or lifestyle education (nutrition for cardiac). The graded exercise test will be used to create a personalized exercise prescription with the target heart rate range calculated from the test and the lifestyle education group will use their ratings of perceived exertion for their exercise prescription.
Who can participate
Age range
60 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are eligible for cardiac rehabilitation by having had a cardiac event such as a myocardial infarction (heart attack), heart failure, percutaneous coronary intervention or angioplasty with stent, coronary artery bypass graft, or heart valve surgery in the past 6 months.
* Lives in, or plans to reside in, the Springfield, MA, or greater Detroit, MI, area for the next year.
* Recruited from a Phase 2 Cardiac Rehabilitation Center at either Baystate Medical Center or Henry Ford Health System.
* Age ≥ 60 years
* Agrees to attend at least 18 sessions of cardiac rehabilitation after randomization
* Agrees to attend cardiac rehabilitation at least twice a week
Exclusion Criteria: These include conditions that alter the physiology and monitoring of resting and exercise heart rate. These also include conditions that might limit an individual's ability to exercise.
* Permanent atrial fibrillation
* Heart transplant
* Left-ventricular assist devices
* Stable angina
* High-risk un-revascularized coronary artery disease
* Symptomatic peripheral artery disease
* Aortic and/or mitral stenosis
* Any condition where exercise testing or training might be unsafe or limited
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.