Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial

NCT05925634 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-07-09

No results posted yet for this 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

Interventions

BEHAVIORAL

RPE (usual care)

Patients in the active comparator group will follow standard exercise prescription protocols in cardiac rehabilitation.

BEHAVIORAL

GXT+THHR (intervention)

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.

Sponsors & Collaborators

  • Henry Ford Hospital

    collaborator OTHER
  • University of Pennsylvania

    collaborator OTHER
  • Rutgers, The State University of New Jersey

    collaborator OTHER
  • Springfield College

    collaborator OTHER
  • Baystate Medical Center

    lead OTHER

Principal Investigators

  • Quinn R Pack, MD · Baystate Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2026-07-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05925634 on ClinicalTrials.gov