Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-20 @ 10:32 PM
Study NCT ID:
NCT03925493
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2019-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Prescription in Cardiac Rehabilitation
Sponsor:
Baystate Medical Center
Organization:
Study Overview
Official Title:
Exercise Prescription in Cardiac Rehabilitation: A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-01
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:
None
Brief Summary:
Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease. There are two common methods of exercise prescription, an effort based exercise prescription and target heart rate based exercise prescription. The purpose of this research study is to identify the best way to exercise in cardiac rehabilitation. There are three main goals of this study. First, the investigators want to know if an exercise test should be done near the beginning of cardiac rehabilitation. Second, the investigators want to understand what type of exercises should be recommend to patients. Third, the investigators want to understand if a personal heart rate monitor will improve adherence to a target heart rate for exercise. As part of this study, some patients will undergo an exercise stress test on a treadmill to determine a target heart rate. These patients will be given a heart rate goal to use when they exercise. Some patients will be given a personal heart rate monitor to improve adherence.
Detailed Description:
Cardiac Rehabilitation (CR) is an effective exercise-based lifestyle therapy for patients with cardiac disease that reduces cardiovascular morbidity and mortality, increases quality of life, and is cost-effective. Recent retrospective studies show that higher exercise gains during CR are associated with reduced long-term morbidity and mortality among patients with both coronary artery disease and systolic heart failure. However, it is unclear which methods maximize exercise gains in CR. Recent retrospective studies have suggested that performing stress testing early in CR may allow for better tailoring of an exercise prescription and thus increase exercise gains. In this study, the investigators propose to do a randomized controlled trial of 60 patients at Baystate Medical Center CR, in which two thirds of the patients will undergo exercise testing prior to starting CR. The exercise test will determine the initial target heart rate range (THRR) and will also influence subsequent exercise progression. Additionally, half of the patients undergoing a stress test will receive a personal heart rate monitor to help improve adherence to the exercise prescription and THRR. The primary outcome is to determine feasibility, protocol fidelity, and effect sizes in preparation for a fully powered subsequent trial that will measure the impact of stress testing and a target heart rage range exercise prescription on exercise gain during CR.
Study Oversight
Has Oversight DMC:
True
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?: