High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy

NCT03335332 | Completed

• 1 other identifier: STU 072017-048
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy should not partake in high intensity exercise (HIE) or competitive sport due to safety concerns, there is no clear evidence to support this notion. In fact, two exercise training interventions in this population indicates that regular moderate to vigorous intensity exercise is efficacious for improving exercise capacity and cardiorespiratory fitness, and does not increase arrhythmia burden or adverse events. Moreover, moderate intensity exercise and HIE training significantly increases cardiorespiratory fitness in patients with cardiac disease. Such improvements are associated with substantial reductions in cardiovascular mortality and might outweigh the risk of adverse events in patients with hypertrophic cardiomyopathy (HCM). Having a genetic cardiomyopathy does not grant immunity against lifestyle related cardiometabolic diseases and inactivity is rife in HCM patients likely due to misinformation/education. It is therefore paramount to further explore the benefits of regular moderate intensity exercise and HIE in patients with HCM for proper therapeutic management of the condition.

Conditions

Hypertrophic Cardiomyopathy

Keywords

High intensity exercise; Cardiorespiratory fitness; Stroke volume reserve; Arrhythmia burden

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness

  Change in maximal oxygen uptake (V̇O2max)

  Five months

Secondary Outcomes (3)

• Functional diastolic reserve

  Five months

• Safety - Number of adverse events

  Ten months

• Safety - Number of arrhythmic events

  Ten months

Study Arms (2)

High intensity exercise

EXPERIMENTAL

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

Moderate intensity exercise

ACTIVE COMPARATOR

Behavioral: Moderate intensity exercise

Interventions

High intensity exercise BEHAVIORAL

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.

High intensity exercise

Moderate intensity exercise BEHAVIORAL

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.

Moderate intensity exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 - 80 years old
• Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between 13 and 15 mm along with at least one other piece of evidence of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.

You may not qualify if:

• A history of exercise-induced syncope or arrhythmias (ventricular tachycardia; sustained or non-sustained)
• Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
• Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
• Pregnancy
• Worsening clinical status or advanced heart failure (New York Heart Association class IV symptoms)
• A hypotensive responsive to exercise (an increase in exercise systolic BP throughout the exercise test of \< 20mmHg compared with resting values, or an initial increase in systolic BP \> 20mmHg with a subsequent fall by peak exercise of \> 20mmHg, or a continuous decrease in systolic BP throughout the test of \> 20mmHg, compared with baseline BP)
• Left ventricular systolic dysfunction (left ventricular ejection fraction \< 55 % by echocardiography)
• Coronary artery disease as evidenced by prior myocardial infarction or angina
• Cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
• A chronic orthopaedic injury which limits the ability to exercise
• Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Biotronik SE & Co. KG: collaborator
• American College of Sports Medicine: collaborator
• American Heart Association: collaborator

Study Sites (1)

The Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

Related Publications (1)

• MacNamara JP, Dias KA, Hearon CM Jr, Ivey E, Delgado VA, Saland S, Samels M, Hieda M, Turer AT, Link MS, Sarma S, Levine BD. Randomized Controlled Trial of Moderate- and High-Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy: Effects on Fitness and Cardiovascular Response to Exercise. J Am Heart Assoc. 2023 Oct 17;12(20):e031399. doi: 10.1161/JAHA.123.031399. Epub 2023 Oct 13.

  PMID: 37830338 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Benjamin D Levine, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: November 7, 2017
• Study Start: January 31, 2018
• Primary Completion: July 26, 2022
• Study Completion: December 20, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)