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Exercise Study Including Patients With Hypertrophic Cardiomyopathy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01165749
Enrollment
120
Registered
2010-07-20
Start date
2010-05-31
Completion date
2012-04-30
Last updated
2010-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Hypertrophic

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.

Interventions

BEHAVIORALstop exercising

Sponsors

University of Michigan
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Ages 18 - 80 years old. 2. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) \> 13 mm in any wall segment. 3. Exercise £ 30 minutes, 1 day per week for the previous 3 months. 4. Agreement to be a participant in the study protocol and willing/able to return for follow-up.

Exclusion criteria

1. History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia). 2. Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy. 3. Less than 3 months post septal reduction therapy (surgery or catheter based intervention). 4. Hypotensive response to exercise (\> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure). 5. Pregnancy. 6. ICD placement in last 3 months or scheduled. 7. Life expectancy less than 12 months. 8. Inability to exercise due to orthopedic or other non-cardiovascular limitations.

Design outcomes

Primary

MeasureTime frame
Improvement in ability to perform activities and tasks.4 months

Secondary

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

Countries

United States

Contacts

Primary ContactLisa Garrett
lisamariegarrett@gmail.com(650) 736-7878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026