What side effects are associated with this type of intervention?

Common treatments for heart attack include medications, lifestyle changes, and cardiac rehabilitation programs. Cardiac rehabilitation often involves exercise prescriptions like Graded Exercise Test + Target Heart Rate Range (GXT-THRR) and Rating of Perceived Exertion (RPE). The known side effects of these exercise-based treatments can include muscle soreness, fatigue, and in rare cases, adverse cardiovascular events such as arrhythmias or heart strain, especially if the exercise intensity is not properly managed. It is crucial for patients to be monitored by healthcare professionals to minimize these risks.

What other types of research exist?

Promising novel alternatives for heart attack patients include High-Intensity Interval Training (HIT), which has shown greater improvements in exercise capacity compared to moderate-intensity continuous training. Additionally, remote monitoring and behavioral economics strategies have been effective in managing heart failure and could be adapted for post-heart attack rehabilitation. These methods offer personalized, efficient, and potentially more engaging approaches to cardiac rehabilitation.

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Behavioural Intervention

Targeted Exercise Prescription for Cardiac Rehabilitation (PACE SETTER Trial)

Q: What prior FDA approvals exist?

FDA-approved treatments for heart attacks primarily include medications such as thrombolytics, antiplatelet agents, beta-blockers, ACE inhibitors, and statins. These treatments aim to restore blood flow, reduce heart workload, and prevent further clot formation. While the Graded Exercise Test + Target Heart Rate Range (GXT-THRR) and Rating of Perceived Exertion (RPE) methods focus on personalized exercise prescriptions for cardiac rehabilitation, they are not directly related to FDA-approved drug treatments but are complementary strategies to improve cardiovascular health post-heart attack.

Phase 2

Recruiting

Led By Quinn R Pack, MD

Research Sponsored by Baystate Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agrees to attend cardiac rehabilitation at least twice a week

Agrees to attend at least 18 sessions of cardiac rehabilitation after randomization

Must not have

Permanent atrial fibrillation

Stable angina

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at end of cr up to 2 years follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two exercise plans for older adults with heart disease. One plan has a set goal, while the other lets participants decide their effort level. The goal is to see which plan improves fitness and health outcomes better.

Who is the study for?

This trial is for older adults (60+) who've had a recent heart event like a heart attack, bypass surgery, or valve replacement and are eligible for cardiac rehab. They must live near Springfield, MA or Detroit, MI and commit to at least 18 rehab sessions.

What is being tested?

The study compares two exercise prescriptions in cardiac rehab: one based on graded exercise tests with target heart rate ranges (GXT-THRR), the other on perceived exertion levels (RPE). It also examines psychological feedback's impact on fitness.

What are the potential side effects?

There may not be direct side effects from the interventions as they involve different methods of prescribing exercise. However, participants should be aware of their physical limits during rehabilitation exercises to avoid potential strain or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to go to cardiac rehab at least twice a week.

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I agree to attend 18 or more cardiac rehab sessions after being selected.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a constant irregular heartbeat.

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My chest pain is consistent and manageable.

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I have pain in my legs due to poor blood flow.

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I have had a heart transplant.

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I have severe heart artery blockage that hasn't been treated with surgery.

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I have a narrowing in my heart's aortic or mitral valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of cr up to 2 years follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of cr up to 2 years follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of cr up to 2 years follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Functional Fitness

Secondary study objectives

Change in functional fitness at 6 months

Change in physical performance at 6 months

Short Physical Performance Battery

+1 more

Other study objectives

Admission to the hospital (full admission or observation status) with apparent life-threatening illness

Change in 7-day % time in Moderate to Vigorous Physical Activity

Change in Quality of Life

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GXT+ THHR (intervention)Experimental Treatment1 Intervention

Patients assigned to the intervention group will complete a GXT approximately one week later and ideally prior to the 4th cardiac rehabilitation session. Resting and peak heart rate from the GXT will be recorded and used to calculate a target heart rate range (THRR) using the Karvonen formula (60-85% Heart rate reserve). After the test, they will receive psychoeducational feedback (PF) about their test results and exercise performance. After the PF, we will discuss the THRR and how it will be used to guide exercise intensity in CR. Patients in the intervention group will use their THHR to adjust their exercise intensity. For the first 6 cardiac rehabilitation sessions, patients will receive feedback about heart rate from the PolarHR monitor, research staff and CR staff when available. The goal is for patients to exercise in THRR for the majority of each exercise session.

Group II: RPE (usual care)Active Control1 Intervention

Participants randomized to usual care (RPE) will not complete a GXT. They will instead be scheduled for an approximately 5-minute educational session (i.e., time/attention-matched control condition) where they will receive information about heart-healthy nutrition. This is standard care at both sites. Patients in the control group will follow standard exercise prescription protocols in CR. This will include a baseline exercise assessment on exercise equipment in the gym (e.g., treadmill, elliptical, rower, NuStep, and/or stationary bicycle) as appropriate. Based on exercise levels achieved on the first day, patients will be given exercise recommendations for their 2nd session of CR and so forth. Participants will be asked to exercise at a moderate intensity RPE level at both sites. As the patients progress in CR, patients will increase their time, intensity, and mode of exercise guided by RPE and clinical assessment.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exercise-based treatments for heart attack patients, such as the Graded Exercise Test + Target Heart Rate Range (GXT-THRR) and Rating of Perceived Exertion (RPE), work by improving cardiovascular fitness, enhancing heart function, and promoting overall physical health. GXT-THRR involves a personalized exercise plan based on a graded exercise test, which helps to determine the optimal heart rate range for safe and effective workouts. This method ensures that patients exercise at an intensity that maximizes cardiovascular benefits while minimizing risks. RPE, on the other hand, allows patients to self-assess their exertion levels and adjust their exercise intensity accordingly. This approach empowers patients to listen to their bodies and avoid overexertion. Both methods are crucial for heart attack patients as they help to strengthen the heart, improve blood flow, and reduce the likelihood of future cardiac events, ultimately enhancing recovery and long-term health outcomes.