High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03335332|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy||Behavioral: High intensity exercise Behavioral: Moderate intensity exercise||Not Applicable|
Regular exercise reduces the risk of all-cause and cardiovascular mortality in the general population. Specifically, higher cardiorespiratory fitness is associated with a 10 - 20 % reduction in mortality risk for every 1 MET (metabolic equivalent tasks) improvement in fitness. A high degree of fitness is also protective against the development of heart failure and exercise training has become the standard of care for most patients with cardiovascular disease to improve functional capacity, and reduce morbidity and mortality. However, hypertrophic cardiomyopathy, the most common inherited cardiovascular disease, may be an exception. For more than 30 years, hypertrophic cardiomyopathy (HCM) has been identified as the most common cause of death in young athletes, and patients with HCM are excluded from participation in competitive sports. The fear of provocation of sudden cardiac death has often been extended to non-competitive athletic activities in such patients, though there is a distinct lack of evidence about the safety of exercise in this population. A recent multicenter clinical trial provided evidence that moderate intensity exercise (MIE) may be safe in this population, though the increase in fitness with this training paradigm was modest. Alternatively, an extensive series of reviews published over the last five years advocate for high intensity interval training (HIIT) as an efficacious stimulus for increasing cardiorespiratory fitness in clinical adult populations, including those with heart failure. While a pilot investigation and preliminary findings suggest that moderate to vigorous intensity exercise may be safe and efficacious in patients with HCM, and even protective in animal models, there is no Level A or B evidence comparing the efficacy or safety of MIE and high intensity exercise (HIE) training in this patient population to guide exercise prescription. Therefore, the primary purpose of this exercise trial is to compare the efficacy and safety of supervised MIE and HIE training in adults with HCM. Specific aims and hypotheses of the project are as follows:
Aim 1: Compare the efficacy of a high intensity and moderate intensity exercise intervention to improve cardiorespiratory fitness and functional diastolic reserve in patients with HCM.
- Primary hypothesis: HIE will result in greater increases in maximal oxygen uptake (V̇O2max) than MIE in patients with HCM.
- Secondary hypothesis: HIE will improve stroke volume reserve to a greater degree than MIE in patients with HCM.
Aim 2: To evaluate the safety of HIE training in patients with HCM.
- Hypothesis: Regular exercise training of a high or moderate intensity will be safe (no serious adverse events) in this patient population. Specifically, it is hypothesised that HIE will not increase arrhythmia burden in patients with HCM.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of High Intensity Exercise (HIE) for Increasing Cardiorespiratory Fitness in Patients With Hypertrophic Cardiomyopathy (HCM)|
|Actual Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: High intensity exercise
A training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions will supervised at our hospital based fitness centre until the subject is confident to complete the training independently. All HIIT sessions will be supervised over the intervention.
Behavioral: High intensity exercise
The exercise groups will receive identical exercise prescription for the first two months of the intervention, after which the HIE group will incorporate HIIT in their exercise regimen. The reason for this approach is to include a period of general conditioning and progressively increase intensity prior to submitting volunteers to HIE. This approach considers participant safety as arrhythmias may be uncovered during the first two months of MIE training. It will also improve participant compliance by increasing exercise self-efficacy and confidence prior to commencing HIIT.
|Active Comparator: Moderate intensity exercise||
Behavioral: Moderate intensity exercise
A training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions in both exercise groups (MIE and HIE) will supervised at our hospital based fitness centre until the subject is confident to complete the training independently.
- Cardiorespiratory fitness [ Time Frame: Five months ]Change in maximal oxygen uptake (V̇O2max)
- Functional diastolic reserve [ Time Frame: Five months ]Change in stroke volume reserve
- Safety - Number of adverse events [ Time Frame: Ten months ]Adverse events during the study will be recorded
- Safety - Number of arrhythmic events [ Time Frame: Ten months ]Number of arrhythmic events will be assessed by an implantable loop recorder
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335332
|Contact: Katrin A Dias, PhD||214-345-6504||KatrinDias@texashealth.org|
|United States, Texas|
|The Institute for Exercise and Environmental Medicine||Recruiting|
|Dallas, Texas, United States, 75231|
|Contact: Mary B Childers 214-345-6459 MaryBChilders@texashealth.org|
|Principal Investigator: Benjamin D Levine, M.D.|
|Principal Investigator:||Benjamin D Levine, MD||University of Texas Southwestern Medical Center|