Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
PACE SETTER
Improving Outcomes From Cardiac Rehabilitation Among Older Adults Through Exercise Testing and Individualized Exercise Intensity Prescriptions
1 other identifier
interventional
320
1 country
2
Brief 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:
- 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2023
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
August 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 9, 2025
August 1, 2024
3 years
June 22, 2023
July 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Functional Fitness
Change in functional fitness as measured by 6 minute walk from baseline to cardiac rehabilitation (CR) completion.
Baseline to final CR session
Secondary Outcomes (4)
Training exercise workload
3rd CR session to final CR session
Short Physical Performance Battery
Baseline to final CR session
Change in functional fitness at 6 months
From end of final CR session to 6 months later.
Change in physical performance at 6 months
From end of final CR session to 6 months later.
Other Outcomes (13)
Self-efficacy (task efficacy)
Pre-Post GXT
Fear of Exercise
Pre-Post GXT
Reassurance
Pre-Post GXT
- +10 more other outcomes
Study Arms (2)
RPE (usual care)
ACTIVE COMPARATORParticipants 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.
GXT+ THHR (intervention)
EXPERIMENTALPatients 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.
Interventions
Patients in the active comparator group will follow standard exercise prescription protocols in cardiac rehabilitation.
Patients in the personalized care group will perform a graded exercise test and the peak heart rate from the test will allow the researcher to calculate a target heart rate range (THRR). Then, the patients will receive psychoeducational feedback (PF) about their test results and exercise performance. After PF, their THRR will be reviewed and how it will be used to guide exercise intensity in CR will be discussed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baystate Medical Centerlead
- Henry Ford Hospitalcollaborator
- University of Pennsylvaniacollaborator
- Rutgers, The State University of New Jerseycollaborator
- Springfield Collegecollaborator
Study Sites (2)
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Quinn R Pack, MD
Baystate Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessment of the 6- minute walk test, handgrip strength, and Short Physical Performance Battery \[SPPB\]) will be performed by a blinded research team member. The blinding will occur at baseline, end of cardiac rehabilitation, and at 6 months after cardiac rehabilitation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
June 29, 2023
Study Start
August 10, 2023
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
July 9, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share