Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925634
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-06-22
Brief Title:
Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial
Sponsor:
Baystate Medical Center
Organization:
Baystate Medical Center
Study Overview
Official Title:
Improving Outcomes From Cardiac Rehabilitation Among Older Adults Through Exercise Testing and Individualized Exercise Intensity Prescriptions
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE SETTER
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
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 ones 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 ie blurry vision chest paintightness difficulty breathing and 2 anxiety about painweakness sensations during exercise ie jointbackbody pain aches soreness
Exercise Perception Questionnaire This survey uses relevant subscales of the Intrinsic Motivation Inventory and will assess patient interestenjoyment as well as perceived choice competence pressuretension and effort
Preference for and Tolerance of Exercise Intensity Questionnaire PRETIE-Q This validated tool reflects a patients 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 patients 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 11 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 ie 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
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 ones 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 ie blurry vision chest paintightness difficulty breathing and 2 anxiety about painweakness sensations during exercise ie jointbackbody pain aches soreness
Exercise Perception Questionnaire This survey uses relevant subscales of the Intrinsic Motivation Inventory and will assess patient interestenjoyment as well as perceived choice competence pressuretension and effort
Preference for and Tolerance of Exercise Intensity Questionnaire PRETIE-Q This validated tool reflects a patients 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 patients 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 11 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None