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Study of Exercise Training in Hypertrophic Cardiomyopathy

NCT01127061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2019-02-15

Study results available
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Summary

The investigators propose a pilot randomized controlled trial to determine the safety and potential benefits of moderate intensity exercise in patients with hypertrophic cardiomyopathy. The investigators hypotheses are that exercise parameters derived from a baseline cardiopulmonary exercise test will target an appropriately safe level of exercise intensity that will not cause significant arrhythmias or exacerbate symptoms and that exercise training for 4 months will result in significant improvements in peak oxygen consumption (peak VO2) and quality of life, with neutral effects on the clinical characteristics.

Conditions

  • Cardiomyopathy, Hypertrophic

Interventions

BEHAVIORAL

Exercise training

4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data. Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.

Sponsors & Collaborators

Principal Investigators

  • Sara Saberi, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-09-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127061 on ClinicalTrials.gov