An interventional study of Graded Exercise Stress test (GXT) with Target Heart Rate Range and Heart rate monitors in Percutaneous Coronary Intervention, Myocardial Infarction and Coronary Artery Bypass Graft, sponsored by Baystate Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Baystate Medical Center · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 48 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
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Patients in the control group will follow standard exercise prescription protocols in CR. Exercise intensity will be guided by the patient's reported rating of perceived exertion (RPE). The modified Borg scale will be used by the patients to determine their RPE. Therefore, a scale of 1-10 will be used. The general goal will be to exercise between intensity level 3 or 4 (i.e. moderate intensity), per current program standards. Based on exercise levels achieved on the first day, patients will be given exercise recommendations for their 2nd session of CR and so forth. As the patients progress in CR, patients will increase their time, intensity, and mode of exercise as appropriate. Exercise progression will be guided by RPE and clinical assessment.
Patients randomly assigned to this group will complete a graded exercise test (GXT) per standard protocols. The researchers will obtain the patients peak heart rate from this stress test. Obtaining an accurate peak heart rate will allow for the calculation of a target heart rate range (THRR) using the Karvonen formula. Based upon the Karvonen formula, the THRR will be between 60-80% of the patient's heart rate reserve. The Karvonen formula can be calculated as follows ((peak heart rate - resting heart rate) X % intensity (0.6 or 0.8) + resting heart rate)). An example would be: (155 -75) X (.6) + 75) = 123; ((155 - 75) X (.8) + 75 = 139) THRR: 123 - 139. Patients will then adjust their exercise intensity to match this target heart rate range for the duration of their time in cardiac rehabilitation. Cardiac rehabilitation staff will provide feedback about heart rate when they are able.
Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range
Patients randomly assigned to this group will also undergo a stress test (GXT) and exercise within a target heart rate range (THRR) during cardiac rehabilitation comparable to second arm of the trial. Additionally, they will receive a personal heart rate monitor (HRM). This monitor will consist of a polar heart rate chest strap and polar watch. Patients will be asked to wear this during cardiac rehabilitation and adjust their own exercise intensity. This will provide continuous feedback to the patient about their heart rate. Cardiac rehabilitation staff will also provide feedback when available. The investigators are using the heart rate monitors because cardiac rehab staff are not always able to adjust exercise intensity for all patients, and telemetry is not always used.
Behavioral: Graded Exercise Stress test (GXT) with Target Heart Rate Range · Behavioral: Heart rate monitors
Patients assigned to one of two intervention groups will complete a GXT prior to the 4th CR session. The GXT will be completed in Baystate Medical Center's stress lab using standard protocols. This test will be used to set the target heart rate range, which will guide exercise intensity for the remainder of exercise training in cardiac rehabilitation.
Heart rate monitors (HRM) will be given to half of the patients randomly assigned to exercise stress testing group. Patients will receive a polar heart rate chest strap and polar watch. Patients will be asked to wear both, the chest strap and the watch during cardiac rehabilitation. Ultimately, we hope that the use of HRM is not necessary, but it may be needed to assure that patients in the THHR are able to consistently know their HR and adjust their exercise prescription. This will also increase the likelihood that there is a difference in heart rates between the THRR group from the RPE group.
Recruit 60 patients
The number of patients that signed informed consent to participate in the study
Time frame: One year
Retain patients for at least 12 exercise sessions of cardiac rehab
The percentage of patients that exercised for at least 12 sessions of cardiac rehab
Time frame: within 3 months of recruitment
Peak exercise capacity at the completion of cardiac rehabilitation
Peak VO2 as measured on a maximal cardiopulmonary stress test
Time frame: Within 6 months of study enrollment
Change in functional exercise capacity from baseline to end of cardiac rehab
The change in functional exercise capacity as measured in METS as calculated using the online formula, http://www.fedel.com/mets/, obtained from calibrated treadmill speed and incline during usual exercise training workloads.
Time frame: Within 6 months of study enrollment
Adherence to Cardiac Rehabilitation (CR)
Total number of CR sessions completed
Time frame: Within 6 months of enrollment
Change in Patient Exercise Confidence
Patients confidence, fear, and anxiety will be measured using surveys at baseline, after 6 sessions of cardiac rehab, and at the end of cardiac rehab. The confidence ruler is a 0 to 10 scale. A higher score on the confidence survey, indicates a greater level of confidence. A minimum score of 0 and a max score of 10 will be used per question, therefore, patients can receive a minimum score of 0 (low confidence) and a maximum score of 100 (high confidence). Fear and Anxiety will be measured using an anxiety questionnaire. Each question has a scale from 1 to 5 indicting very little fear to very fearful. A lower score on the anxiety scale indicates less anxiety or fear. Patients can receive a score from 6 (very little fear) to 30 (very fearful).
Time frame: Within 6 months of enrollment
The number of patients with at least one or more adverse events in CR
The percentage of patients that have an adverse clinical event that precludes or stops exercise during cardiac rehabilitation. The adverse event is determined by the opinion of the treating clinician, the patient was unable to start or continue exercising based on one or more of the following subcategories; high or low blood pressure, dyspnea, tachycardia, or chest pain as defined by the treating clinician who stopped or precluded exercise.
Time frame: Within 6 months of enrollment
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Sap, Icf, Csr
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