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NCT05925634 · ClinicalTrials.gov registry record · Phase 2
Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
A Phase 2 study of Heart Failure and Myocardial Infarction, sponsored by Baystate Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 2
- Study locations
NCT05925634 is a Phase 2 study of Heart Failure and Myocardial Infarction that is actively recruiting participants, run by Baystate Medical Center. The registered enrollment target is 320 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05925634, a Phase 2 study of Heart Failure and Myocardial Infarction, is actively recruiting participants, sponsored by Baystate Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL RPE (usual care)
- BEHAVIORAL GXT+THHR (intervention)
Study Locations (2)
Massachusetts
- Baystate Medical Center - Springfield
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05925634
The ClinicalTrials.gov registry entry for NCT05925634 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (84% lower). The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which RPE (usual care) is the first listed.
NCT05925634 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT05925634 about?
NCT05925634 is a clinical study titled "Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial". 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 repeati...
What is the current status of trial NCT05925634?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2023-08-10. Estimated completion is 2027-06-30.
What conditions does trial NCT05925634 study?
This clinical trial studies the following conditions: Heart Failure, Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass, Cardiac Valve Surgery.
What interventions are being tested in trial NCT05925634?
The interventions under investigation include: RPE (usual care) (BEHAVIORAL), GXT+THHR (intervention) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05925634?
This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05925634 being conducted?
This trial has 2 study locations across Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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