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Behavioural Intervention
Targeted Exercise Prescription for Cardiac Rehabilitation (PACE SETTER Trial)
Phase 2
Recruiting
Led By Quinn R Pack, MD
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agrees to attend cardiac rehabilitation at least twice a week
Agrees to attend at least 18 sessions of cardiac rehabilitation after randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of cr up to 2 years follow-up
Awards & highlights
PACE SETTER Trial Summary
This trial will compare two exercise prescriptions for heart disease patients over 60 to determine which is more effective. Participants will wear monitors and attend 18 sessions of cardiac rehabilitation.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There may not be direct side effects from the interventions as they involve different methods of prescribing exercise. However, participants should be aware of their physical limits during rehabilitation exercises to avoid potential strain or injury.
PACE SETTER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to go to cardiac rehab at least twice a week.
Select...
I agree to attend 18 or more cardiac rehab sessions after being selected.
Select...
I am 60 years old or older.
PACE SETTER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at end of cr up to 2 years follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of cr up to 2 years follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Functional Fitness
Secondary outcome measures
Change in functional fitness at 6 months
Change in physical performance at 6 months
Short Physical Performance Battery
+1 moreOther outcome measures
Admission to the hospital (full admission or observation status) with apparent life-threatening illness
Change in 7-day % time in Moderate to Vigorous Physical Activity
Change in Quality of Life
+10 morePACE SETTER Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GXT+ THHR (intervention)Experimental Treatment1 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 Control1 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 Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyOTHER
429 Previous Clinical Trials
63,912 Total Patients Enrolled
Springfield CollegeOTHER
9 Previous Clinical Trials
2,617 Total Patients Enrolled
University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,881,967 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have a left-ventricular assist device.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.You have a health condition that could make it unsafe for you to do exercise testing or training.I have had a heart transplant.You live in or plan to move to the Springfield, MA, or greater Detroit, MI, area for the next year.You are not receiving care from a specific type of heart rehabilitation center at Baystate Medical Center or Henry Ford Health System.I have severe heart artery blockage that hasn't been treated with surgery.I am 60 years old or older.I have a narrowing in my heart's aortic or mitral valve.
Research Study Groups:
This trial has the following groups:- Group 1: RPE (usual care)
- Group 2: GXT+ THHR (intervention)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for this experiment inclusive of individuals over 40 years old?
"This research project is open to elderly persons aged 60 and up, with a maximum age of 101."
Answered by AI
Does the Food and Drug Administration sanction GXT+ THHR (intervention)?
"The safety of GXT+ THHR was estimated to be a 2 since there is preliminary data confirming its security but none verifying its efficacy."
Answered by AI
Are there any unused slots left in this medical trial?
"According to the information provided on clinicaltrials.gov, this study has already concluded its recruitment period and is not actively searching for participants any longer; however, there are 1104 other trials that are still recruiting patients as of today's date. The trial was originally posted in July 1st 2023 and edited most recently in June 22nd 2023."
Answered by AI
Could I potentially partake in this experiment?
"This medical study is seeking roughly 320 participants aged between 60 and 101 years old who have previously suffered a heart attack. To be considered, potential candidates must meet these criteria."
Answered by AI
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