Targeted Exercise Prescription for Cardiac Rehabilitation

(PACE SETTER Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Quinn Pack, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Baystate Medical Center

Disqualifiers: Atrial fibrillation, Heart transplant, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is comparing two exercise plans for older adults with heart disease. One plan has a set goal, while the other lets participants decide their effort level. The goal is to see which plan improves fitness and health outcomes better.

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 data supports the effectiveness of the treatment GXT+THHR, Graded Exercise Test + Target Heart Rate Range Prescription, in 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 exercise capacity compared to not using GXT. Patients who followed this method had a significant increase in their ability to exercise, as measured by metabolic equivalents of task (METs). ^{1 2 3 4 5}

Is targeted exercise prescription for cardiac rehabilitation safe for humans?

The research does not provide specific safety data for targeted exercise prescription in cardiac rehabilitation, but it does not report any safety concerns, suggesting it is generally safe for humans. ^{1 4 6 7 8}

How does the GXT+THHR treatment differ from other treatments for cardiac rehabilitation?

The GXT+THHR treatment is unique because it uses a graded exercise test to determine a personalized target heart rate for exercise, which has been shown to significantly improve exercise tolerance in cardiac rehabilitation compared to not using this method. This approach tailors the exercise intensity to each individual's capabilities, potentially leading to better outcomes. ^{1 3 9 10 11}

Research Team

Quinn Pack, MD

Principal Investigator

Baystate Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• GXT+THHR (Behavioural Intervention)
• RPE (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Henry Ford Health System Detroit, MI

Baystate Medical Center Springfield, MA

Who Is Running the Clinical Trial?

Baystate Medical Center

Lead Sponsor

Trials

67

Patients Recruited

44,500+

Rutgers, The State University of New Jersey

Collaborator

Trials

471

Patients Recruited

81,700+

Springfield College

Collaborator

Trials

10

Patients Recruited

2,900+

University of Pennsylvania

Collaborator

Trials

2118

Patients Recruited

45,270,000+

Henry Ford Hospital

Collaborator

Trials

27

Patients Recruited

7,400+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Relation of a Maximal Exercise Test to Change in Exercise Tolerance During Cardiac Rehabilitation. [2023]

2. United States 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. [2020]

3. England 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. [2023]

4. United States 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. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Pretest variables that improve the predictive value of exercise testing in women. [2017]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Correlates of heart rate recovery over 20 years in a healthy population sample. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of autonomic function underlying slow postexercise heart rate recovery. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Target dyspnea ratings predict expected oxygen consumption as well as target heart rate values. [2006]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise testing in cardiac rehabilitation. Role in prescribing exercise. [2007]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Individual assessment of intensity-level for exercise training in patients with coronary artery disease is necessary. [2019]