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Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial

Study acronym: PACE SETTER
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 30, 2026 → Oct 24, 2026
See other at-risk trials from Baystate Medical Center

Record History

  1. Phase changed: Phase 2 → not applicable
    • Enrollment closed, study ongoing
    • Primary completion pushed from Jul 30, 2026 to Oct 24, 2026
    • Site details revised at 2 of 2 sites
    v7
  2. Primary completion date: Jun 30, 2026 to Jul 30, 2026v6
  3. Primary completion date: Feb 28, 2026 to Jun 30, 2026v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Jul 3, 2023 to Aug 10, 2023
    • Primary completion date: Feb 2026 to Feb 28, 2026
    • Study completion date: Jun 2027 to Jun 30, 2027
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2023 to Jul 3, 2023
    • Site details revised at 2 of 2 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05925634
Lead Sponsor Baystate Medical Center
Collaborators: Henry Ford Hospital, University of Pennsylvania, Rutgers, The State University of New Jersey, Springfield College
Conditions
(from sponsor)		 Myocardial Infarction, Coronary Artery Bypass, Percutaneous Coronary Intervention, Heart Failure, Cardiac Valve Surgery
Related terms Heart Failure, Myocardial Infarction
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov