Targeted Exercise Prescription for Cardiac Rehabilitation

(PACE SETTER Trial)

Recruiting at 1 trial location

Overseen By Karen L Riska, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baystate Medical Center

Disqualifiers: Atrial fibrillation, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 37

Duration: 6 months

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different exercise plans to determine which is more effective for people recovering from heart problems. One plan, called GXT+THHR (Graded Exercise Test + Target Heart Rate Range Prescription), uses a heart rate test to set exercise goals. The other, known as RPE (Rating of Perceived Exertion), relies on how hard the exercise feels to the participant. The trial also examines how feedback during exercise might enhance fitness. People who have experienced a heart issue, such as a heart attack or surgery in the last six months, and live in the Springfield, MA, or Detroit, MI, area might be suitable candidates. Participants must attend at least 18 cardiac rehab sessions and agree to exercise regularly. As a Phase 2 trial, this research measures the effectiveness of the exercise plans in an initial, smaller group, offering participants a chance to contribute to important findings in heart recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exercise prescriptions are safe for cardiac rehabilitation?

Research has shown that the GXT+THHR method, which includes a graded exercise test and a target heart rate range, has been generally well-tolerated in past studies. Participants who followed this exercise plan did not experience serious side effects. Some minor issues, such as temporary muscle soreness or tiredness, were noted, which are common when starting new exercise routines. This method tailors exercise intensity to each person, aiming to improve heart health safely. It is important to know that this approach remains under investigation, with researchers closely monitoring its safety and effectiveness. This stage of research indicates that while the treatment appears promising, scientists are still gathering detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to cardiac rehabilitation by using a targeted exercise prescription. Unlike the standard method, which relies on perceived exertion (RPE) to guide exercise intensity, the intervention uses a graded exercise test (GXT) to determine a personalized target heart rate range (THRR). This THRR, calculated using the Karvonen formula, allows for a more precise regulation of exercise intensity, potentially improving outcomes. By focusing on individual heart rate data, this method could enhance the effectiveness of cardiac rehabilitation by optimizing exercise intensity and personalizing patient care.

What evidence suggests that this trial's exercise prescriptions could be effective for cardiac rehabilitation?

Research has shown that using a Graded Exercise Test (GXT) to set a target heart rate for exercise in cardiac rehabilitation improves fitness levels more effectively. In this trial, participants in the GXT+THHR arm will follow this method, which creates a personalized exercise plan, making it easier to exercise at the right intensity. Studies have found that people using this method often feel less afraid of exercising and more confident in their ability to do so. Conversely, participants in the RPE arm will follow the standard method, which uses Rating of Perceived Exertion (RPE) and relies on individuals estimating their own exercise intensity, which can be less accurate. Early evidence suggests that the GXT+THHR approach may lead to better exercise results and possibly long-term health benefits. ^{1 2 3 5 6}

Who Is on the Research Team?

Quinn Pack, MD

Principal Investigator

Baystate Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults (60+) who've had a recent heart event like a heart attack, bypass surgery, or valve replacement and are eligible for cardiac rehab. They must live near Springfield, MA or Detroit, MI and commit to at least 18 rehab sessions.

Inclusion Criteria

I had a heart event like a heart attack or surgery in the last 6 months and qualify for cardiac rehab.

I agree to go to cardiac rehab at least twice a week.

I agree to attend 18 or more cardiac rehab sessions after being selected.

Exclusion Criteria

I have a constant irregular heartbeat.

My chest pain is consistent and manageable.

I have pain in my legs due to poor blood flow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including 6MWT, SPPB, and psychological assessments

1 week

1 visit (in-person)

Treatment

Participants attend at least 18 sessions of cardiac rehabilitation, randomized to either GXT-THRR or RPE

6 months

Up to 36 visits (in-person)

Follow-up

Participants are monitored for long-term clinical outcomes and changes in physical performance

Up to 2 years

Follow-up surveys and phone calls

What Are the Treatments Tested in This Trial?

Interventions

• GXT+THHR
• RPE

Trial Overview

The study compares two exercise prescriptions in cardiac rehab: one based on graded exercise tests with target heart rate ranges (GXT-THRR), the other on perceived exertion levels (RPE). It also examines psychological feedback's impact on fitness.

How Is the Trial Designed?

Group I: GXT+ THHR (intervention) Experimental Treatment 1 Intervention

Patients 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.

Group II: RPE (usual care) Active Control 1 Intervention

Participants 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 is already approved in United States for the following indications:

Approved in United States as Graded Exercise Test + Target Heart Rate Range Prescription for:

• Cardiac rehabilitation in older adults with heart disease

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Recruited

44,500+

Rutgers, The State University of New Jersey

Collaborator

Trials

471

Recruited

81,700+

Springfield College

Collaborator

Trials

10

Recruited

2,900+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Henry Ford Hospital

Collaborator

Trials

27

Recruited

7,400+

Published Research Related to This Trial

Graded exercise tests are essential for determining safe exercise levels for cardiac patients, as they provide critical information on heart rate and electrocardiographic responses during exercise.

The mode of testing influences the responses observed, which helps healthcare providers tailor exercise prescriptions for effective cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing in cardiac rehabilitation. Role in prescribing exercise. Graves, JE., Pollock, ML.[2007]

In a study of 20 individuals with a history of slow heart rate recovery (HRR) after exercise, those with slow HRR showed significantly lower fluctuations in autonomic activity compared to those with normal HRR, indicating impaired vagal reactivation.

The findings suggest that reduced HRR is linked to prolonged sympathetic stimulation and abnormal vagal activity, which may contribute to increased cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of autonomic function underlying slow postexercise heart rate recovery. Davrath, LR., Akselrod, S., Pinhas, I., et al.[2006]

In a study of 30 cardiac patients undergoing a structured Phase III cardiac rehabilitation program, the average exercise intensity was found to be below the recommended minimum threshold of 40% heart rate reserve, with a mean intensity of only 37%.

The findings suggest that the low exercise intensity during rehabilitation may contribute to the variability in effectiveness of cardiac rehabilitation programs in the UK, potentially leading to inadequate improvements in cardiovascular fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insufficient exercise intensity for clinical benefit? Monitoring and quantification of a community-based Phase III cardiac rehabilitation programme: A United Kingdom perspective. Khushhal, A., Nichols, S., Carroll, S., et al.[2020]

In a study of 4,455 cardiac rehabilitation patients, those who had their exercise intensity guided by a target heart rate from a maximal graded exercise test (GXT) showed significantly greater improvements in exercise tolerance, with an increase of +0.44 METs and +17% from baseline compared to those without a GXT.

For patients attending more frequent sessions (24 to 36 visits), the benefits of using a GXT were even more pronounced, resulting in an increase of +0.51 METs and +19%, suggesting that individualized heart rate targets can optimize exercise capacity during cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of a Maximal Exercise Test to Change in Exercise Tolerance During Cardiac Rehabilitation. Brawner, CA., Pack, Q., Berry, R., et al.[2023]

In a study of 403 women undergoing graded exercise testing (GXT) for coronary artery disease (CAD), factors like older age, higher BMI, diabetes status, and use of cardiovascular medications were found to improve the predictive value of the test.

Specifically, HDL cholesterol levels and beta blocker usage were identified as the most significant predictors of a positive GXT result, suggesting that additional pretest variables can enhance clinical decision-making for women at risk of CAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretest variables that improve the predictive value of exercise testing in women. Lamont, LS., Bobb, J., Blissmer, B., et al.[2017]

In a study of 91 male patients with coronary artery disease, the heart rate at the anaerobic threshold (AT) showed significant variability compared to the commonly used target heart rate (THR) for exercise training, indicating that relying solely on calculations for THR may not be accurate for all individuals.

The findings suggest that for effective cardiac rehabilitation, exercise intensity should be determined directly through measurement of AT rather than relying on calculated heart rate parameters, as many patients had heart rates at AT that differed by more than 10% from their THR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual assessment of intensity-level for exercise training in patients with coronary artery disease is necessary. Nieuwland, W., Berkhuysen, MA., Van Veldhuisen, DJ., et al.[2019]

A new formula was developed to accurately predict heart rate at the anaerobic threshold (HRAT) for myocardial infarction patients, taking into account the effects of β-blockers, using data from 196 patients.

The formula was validated with a separate group of 71 patients, showing a mean absolute error of only 5.5 bpm, making it a reliable tool for prescribing exercise when cardiopulmonary exercise testing is not possible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Formula to Predict Heart Rate at Anaerobic Threshold That Considers the Effects of β-Blockers in Patients With Myocardial Infarction: MULTI-INSTITUTIONAL RETROSPECTIVE CROSS-SECTIONAL STUDY. Nemoto, S., Kasahara, Y., Izawa, KP., et al.[2023]

In a study of patients undergoing cardiac rehabilitation, the predicted maximum heart rate (HR max) using standard equations often did not match the measured HR max, leading to inaccurate target heart rate (THR) calculations for exercise intensity.

Only a small percentage of patients (0 to ≤61%) had their exercise training heart rates fall within the recommended guideline-based range of 50-80% of their measured heart rate reserve, indicating that using predicted HR max may not be effective for ensuring appropriate exercise intensity in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Among Patients Taking Beta-Adrenergic Blockade Therapy, Use Measured (Not Predicted) Maximal Heart Rate to Calculate a Target Heart Rate for Cardiac Rehabilitation. Keteyian, SJ., Steenson, K., Grimshaw, C., et al.[2023]

Patients with chronic obstructive pulmonary disease (COPD) can effectively use dyspnea ratings as a target for exercise intensity, similar to how healthy individuals use target heart rates, demonstrating that both methods can help achieve expected exercise levels.

In a study involving 44 COPD patients, both dyspnea ratings and heart rate targets resulted in comparable exercise intensities, indicating that dyspnea ratings may be a valid alternative for monitoring exercise in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target dyspnea ratings predict expected oxygen consumption as well as target heart rate values. Mejia, R., Ward, J., Lentine, T., et al.[2006]

In a study involving 32 cardiac rehabilitation patients, neither exercise prescription method (graded exercise testing with target heart rate vs. rating of perceived exertion) significantly improved exercise self-efficacy or reduced exercise fear by the end of the rehabilitation program.

Contrary to expectations, patients showed sustained or increased fear of exercise, indicating that additional psychological support may be necessary to effectively address exercise-related fears in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Testing and Cardiac Rehabilitation in Patients with Coronary Heart Disease on Fear and Self-Efficacy of Exercise: A Pilot Study. Shea, MG., Farris, SG., Hutchinson, J., et al.[2023]

In a study of 2730 participants over 20 years, 5% developed slow heart rate recovery (HRR) after exercise, which is linked to higher mortality risk and indicates impaired heart function.

Factors such as higher body mass index, obesity, smoking, low education, and metabolic conditions like hypertension and diabetes were significantly associated with the development of slow HRR, highlighting the importance of managing these risk factors in young adulthood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of heart rate recovery over 20 years in a healthy population sample. Carnethon, MR., Sternfeld, B., Liu, K., et al.[2022]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05925634

Improving Cardiac Rehabilitation Exercise Using Target ...

This study aims to conduct a practical two-arm, parallel-group, open-label, efficacy randomized trial comparing Graded Exercise Testing+ Target Heart Rate Range ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11884863/

Effects of Exercise Testing and Cardiac Rehabilitation in ...

This study tested whether exercise prescription methods influence exercise fear and exercise self-efficacy. We hypothesized that use of graded ...

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connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/439157

Improving Cardiac Rehabilitation Exercise Using Target Heart ...

The graded exercise test will be used to create a personalized exercise prescription with the target heart rate range calculated from the test ...

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withpower.com

withpower.com/trial/phase-2-myocardial-infarction-6-2023-6cfc7

Targeted Exercise Prescription for Cardiac Rehabilitation

Research shows that using a Graded Exercise Test (GXT) to set a target heart rate for exercise in cardiac rehabilitation leads to greater improvements in ...

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smartpatients.com

smartpatients.com/trials/NCT05925634

Improving Cardiac Rehabilitation Exercise Using Target ...

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 ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7344739/

Exercise Prescription Guidelines for Cardiovascular Disease ...

The purpose of this review is to provide clinicians with evidence-based techniques for prescribing exercise in the absence of a baseline GXT.