Clinical trial NCT05925634: Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
Official title: Improving Outcomes From Cardiac Rehabilitation Among Older Adults Through Exercise Testing and Individualized Exercise Intensity Prescriptions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myocardial Infarction
Coronary Artery Bypass
Percutaneous Coronary Intervention
Heart Failure
Cardiac Valve Surgery
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: Henry Ford Hospital
name: University of Pennsylvania
name: Rutgers, The State University of New Jersey
name: Springfield College
First posted: 2023-06-29
Enrollment: 320
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A practical two-arm, parallel-group, open-label, efficacy randomized trial.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study aims to conduct a practical two-arm, parallel-group, open-label, efficacy randomized trial comparing Graded Exercise Testing+ Target Heart Rate Range (GXT-THRR) vs. Usual Care (UC) on changes in fitness (as measured by 6MWT, exercise training METs, handgrip strength and Short Physical Performance Battery \[SPPB\]) and PA behavior among 320 patients enrolled in CR. The investigators will recruit older adults (age ≥ 60 years) attending outpatient CR from two complementary but different CR centers. The investigators will compare changes in fear and self-efficacy between these two groups and measure long-term clinical outcomes. The investigators have designed the study to be as generalizable as possible, so most CR programs can immediately apply the results in clinical practice.

Eligible patients who are willing to participate will complete written informed consent. Baseline demographics, comorbidities, and prescribed medications and doses (including beta-blockers) will be collected.

Patients will then undergo a baseline assessment. This will include a 6MWT and SPPB using standard guideline procedures. During this time period, patients will also be fitted with an accelerometer to wear for 7 days (Actigraph, CenterPoint, Pensacola, FL) to assess time spent in moderate to vigorous PA (MVPA). The investigators have significant experience assessing PA, 6MWT, and SPPB, and anticipate few issues in making these measurements. Patients will also complete the following psychological assessments:

* Multidimensional Self-Efficacy for Exercise Scale. Self- efficacy is a robust predictor of exercise and PA behavior and may be influenced by exercise prescription method (GXT-THRR or UC). This validated tool will assess three dimensions of self-efficacy: task efficacy (conﬁdence in performing the elemental aspects of exercise), coping efficacy (conﬁdence in exercising under challenging circumstances), and scheduling efficacy (conﬁdence in being able to schedule regular exercise into one's lifestyle).
* Exercise Sensitivity Questionnaire (ESQ). The ESQ is an 18-item self-report measure developed by Dr. Farris that conceptualizes exercise anxiety as worry and fear about the physical sensations of exercise. The ESQ has two dimensions: (1) anxiety about cardiopulmonary sensations during exercise (i.e., blurry vision, chest pain/tightness, difficulty breathing) and (2) anxiety about pain/weakness sensations during exercise (i.e., joint/back/body pain, aches, soreness).
* Exercise Perception Questionnaire. This survey uses relevant subscales of the Intrinsic Motivation Inventory and will assess patient interest/enjoyment, as well as perceived choice, competence, pressure/tension, and effort.
* Preference for and Tolerance of Exercise Intensity Questionnaire (PRETIE-Q). This validated tool reflects a patient's general attitude towards and tolerance for higher-intensity exercise. We have included this survey as an important baseline measure, which may predict exercise gains and PA patterns.
* 36 Item Short Form Survey (SF-36). This well-validated general QOL survey has been used extensively in CR and provides a useful measure of a patient's overall physical, emotional, and social QOL.
* Fried Frailty Phenotype. This assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity.
* International Physical Activity Questionnaire-Elderly. This well-validated survey will assess levels of physical activity (moderate, moderate-vigorous, vigorous) and sedentary activity.

During the time between informed consent and randomization, patients will continue to undergo CR using UC to guide intensity. This allows for exercise-related baseline measurements to be taken, including the exercise training METs on the 3rd session of CR, as suggested by AACVPR performance measures. It also allows measurement of baseline resting HR, exercise HR, and exercise RPE.

After completing all baseline assessments (including 3 sessions of CR), patients will be randomized (1:1) to either GXT-THRR or UC. Randomization will be stratified based on age, recent cardiac surgery, and site (Baystate vs. Henry Ford.) This will be done because age may have a differential impact on exercise gains; cardiac surgery can limit the available exercise training modalities (i.e., no upper body exercises); and CR site may influence the outcome in unanticipated ways. The investigators will randomize patients through use of the Research Electronic Database Capture (REDCap) software randomization module which allows secure, sequential, and concealed group allocation, as was done in the pilot. REDCap will also be used by both sites to allow uniform data collection, capture, and entry.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria: These include conditions that alter the physiology and monitoring of resting and exercise heart rate. These also include conditions that might limit an individual's ability to exercise.

* Permanent atrial fibrillation
* Heart transplant
* Left-ventricular assist devices
* Stable angina
* High-risk un-revascularized coronary artery disease
* Symptomatic peripheral artery disease
* Aortic and/or mitral stenosis
* Any condition where exercise testing or training might be unsafe or limited

Primary outcomes:
measure: Change in Functional Fitness
timeFrame: Baseline to final CR session
Secondary outcomes:
measure: Training exercise workload
timeFrame: 3rd CR session to final CR session
measure: Short Physical Performance Battery
timeFrame: Baseline to final CR session
measure: Change in functional fitness at 6 months
timeFrame: From end of final CR session to 6 months later.
measure: Change in physical performance at 6 months
timeFrame: From end of final CR session to 6 months later.
Other outcomes:
measure: Self-efficacy (task efficacy)
timeFrame: Pre-Post GXT
measure: Fear of Exercise
timeFrame: Pre-Post GXT
measure: Reassurance
timeFrame: Pre-Post GXT
measure: Exercise Anxiety
timeFrame: Baseline to final CR session
measure: Exercise Self-Efficacy
timeFrame: Baseline to final CR session
measure: Task Efficacy
timeFrame: Baseline to final CR session
measure: Change in Quality of Life
timeFrame: Baseline to final CR session
measure: Change in 7-day % time in Moderate to Vigorous Physical Activity
timeFrame: Baseline to final CR session
measure: Self-reported moderate to vigorous physical activity (MVPA) over the past 7 days
timeFrame: Baseline to CR end, and at 3 and 6 months post CR
measure: Major adverse cardiac event (death, myocardial infarction, stroke)
timeFrame: At end of CR up to 2 years follow-up
measure: Admission to the hospital (full admission or observation status) with apparent life-threatening illness
timeFrame: At end of CR up to 2 years follow-up
measure: Clinically indicated ischemic evaluation (exercise stress test, nuclear stress test, exercise echo, cardiac catheterization)
timeFrame: At end of CR up to 2 years follow-up
measure: Number of sessions of CR completed (maximum of 36) within 6 months of enrollment.
timeFrame: Start to end of CR
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Baystate Medical Center
name: Quinn R Pack, MD
role: PRINCIPAL_INVESTIGATOR
References: