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NCT05925634: PACE SETTER
Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
Phase 2 trial testing RPE (usual care) in Myocardial Infarction in 320 participants. Currently enrolling.
30 July 2026
Quick facts
| Lead sponsor | Baystate Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 320 |
| Start date | 10 August 2023 |
| Primary completion | 30 July 2026 |
| Estimated completion | 30 June 2027 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- RPE (usual care)
- GXT+THHR (intervention)
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Coronary Artery Bypass — all drugs for Coronary Artery Bypass →
- Percutaneous Coronary Intervention — all drugs for Percutaneous Coronary Intervention →
- Heart Failure — all drugs for Heart Failure →
Sponsor
Baystate Medical Center
Who can join
Adults 60 to 99, any sex, with Myocardial Infarction or Coronary Artery Bypass. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05925634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myocardial Infarction
Currently open trials in the same condition.
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- NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients · recruiting
- NCT07138911 — Effect of Home-based Exercise Plan Mediated by Use of Digital Health App on Kinesiophobia and Functional Capacity · NA · recruiting
Other Baystate Medical Center trials
Trials by the same sponsor.
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- NCT07123480 — The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance · NA · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05925634 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baystate Medical Center
- Last refreshed: 9 July 2025
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