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 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:
🦠 Myocardial Infarction 🦠 Coronary Artery Bypass 🦠 Percutaneous Coronary Intervention 🦠 Heart Failure 🦠 Cardiac Valve Surgery
🗓️ Study Start (Actual) 10 August 2023
🗓️ Primary Completion (Estimated) 28 February 2026
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 320
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Springfield, Massachusetts, United States
📍 Detroit, Michigan, United States

📋 Eligibility Criteria

Description

    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:

    • * 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
Ages Eligible for Study: 60 Years to 101 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 June 2023
  • First Submitted that Met QC Criteria 22 June 2023
  • First Posted 29 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024