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Clinical Trials/NCT01165749
NCT01165749
Unknown
Not Applicable

A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy

Stanford University1 site in 1 country120 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy, Hypertrophic
Sponsor
Stanford University
Enrollment
120
Locations
1
Primary Endpoint
Improvement in ability to perform activities and tasks.
Last Updated
15 years ago

Overview

Brief Summary

The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
April 2012
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Ages 18 - 80 years old.
  • Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) \> 13 mm in any wall segment.
  • Exercise £ 30 minutes, 1 day per week for the previous 3 months.
  • Agreement to be a participant in the study protocol and willing/able to return for follow-up.

Exclusion Criteria

  • History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
  • Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
  • Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
  • Hypotensive response to exercise (\> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
  • ICD placement in last 3 months or scheduled.
  • Life expectancy less than 12 months.
  • Inability to exercise due to orthopedic or other non-cardiovascular limitations.

Outcomes

Primary Outcomes

Improvement in ability to perform activities and tasks.

Time Frame: 4 months

Secondary Outcomes

  • Improvement in heart size and function and quality of life (QOL).(4 months)

Study Sites (1)

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