Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-99
SponsorBaystate Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Permanent atrial fibrillation

Heart transplant

Left-ventricular assist devices

Stable angina

Trial design

Design model

Parallel

Treatments tested in this trial

  • RPE (usual care)

    Behavioral

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

  • GXT+THHR (intervention)

    Behavioral

    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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: RPE (usual care)Active comparator 1 intervention
Group B: GXT+ THHR (intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Functional Fitness

Change in functional fitness as measured by 6 minute walk from baseline to cardiac rehabilitation (CR) completion.

Time frame
Baseline to final CR session

Secondary outcomes

1

Training exercise workload

Change in metabolic equivalents of task (METs)-an objective measure of a training exercise workload as changes in scores over time and between groups.

Time frame
3rd CR session to final CR session
2

Short Physical Performance Battery

Change in Short Physical Performance Battery from baseline to final CR session

Time frame
Baseline to final CR session
3

Change in functional fitness at 6 months

Change in functional fitness as measured by 6-minute walk from end of CR to 6 months later.

Time frame
From end of final CR session to 6 months later.
4

Change in physical performance at 6 months

Short Physical Performance Battery from end of CR to 6 months later.

Time frame
From end of final CR session to 6 months later.

Other outcomes

1

Self-efficacy (task efficacy)

Acute change in self-efficacy (task efficacy) measured before and after the intervention (graded exercise test (GXT) vs. time matched control) will be assessed via the Multidimensional Self-Efficacy for Exercise Scale as changes in scores over time and between groups.

Time frame
Pre-Post GXT
2

Fear of Exercise

Acute effects of GXT vs. time matched control on fear will be measured via the Exercise Sensitivity Questionnaire as changes in scores over time and between groups.

Time frame
Pre-Post GXT
3

Reassurance

Acute effects of GXT on reassurance will be measured via the Reassurance Scale as change scores over time and between groups.

Time frame
Pre-Post GXT
4

Exercise Anxiety

Change in exercise anxiety from baseline to final CR session over time and between groups will be measured via the Exercise Sensitivity Questionnaire.

Time frame
Baseline to final CR session

Sponsors and contacts

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Baystate Medical Center

Lead sponsor

Henry Ford Hospital

Collaborator

University of Pennsylvania

Collaborator

Rutgers, The State University of New Jersey

Collaborator

Springfield College

Collaborator