Recruiting

Exercise

Sponsor:

Stanford University

Code:

NCT01165749

Conditions

Cardiomyopathy, Hypertrophic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

stop exercising

Study Details

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.

Conditions

Cardiomyopathy, Hypertrophic

Study ID

NCT01165749

Start date

May, 2010

Status verified date

Jul, 2010

Completion date

Apr, 2012

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

stop exercising

Primary outcome measure

  • Improvement in ability to perform activities and tasks. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Lisa Garrett

(650) 736-7878lisamariegarrett@gmail.com

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Lisa Garrett

650-736-7878lisamariegarrett@gmail.com

Terra Coakley

(650) 725-6186tcoakley@stanford.edu

Principal Investigator:

Dr. Euan Ashley MRCP, DPhil

More Information

Sponsor

Stanford University

Last update posted

Jul 20, 2010

Last verified

Jul, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2010-07-20.