Improving Outcomes From Cardiac Rehabilitation Among Older Adults Through Exercise Testing and Individualized Exercise Intensity Prescriptions

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

• Agrees to attend at least 18 sessions of cardiac rehabilitation after randomization

• Agrees to attend cardiac rehabilitation at least twice a week

Locations
United States
Massachusetts
Baystate Medical Center
RECRUITING
Springfield
Michigan
Henry Ford Health System
RECRUITING
Detroit
Contact Information
Primary
Quinn R Pack, MD
quinn.pack@baystatehealth.org
413-794-5856
Backup
Karen L Riska, PhD
karen.riska@baystatehealth.org
413-794-0303
Time Frame
Start Date: 2023-08-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 320
Treatments
Active_comparator: RPE (usual care)
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.
Experimental: GXT+ THHR (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.
Sponsors
Collaborators: Rutgers, The State University of New Jersey, Springfield College, Henry Ford Hospital, University of Pennsylvania
Leads: Baystate Medical Center

This content was sourced from clinicaltrials.gov