Clinical trial NCT00794027: The Effects of a Yoga Program in Heart Failure Patients
Official title: The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
yoga
quality of life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed research will investigate the clinical outcomes associated with a modified yoga training program in patients with heart failure (HF). HF patients (15-20) will participate in a modified yoga program during an 8 week period, two times per week with instruction for home practice. Baseline measures and follow-up will be taken after 8 weeks. The underlying hypothesis to be tested is that yoga-induced improvements in nervous system and skeletal muscle function will yield positive effects on clinical outcomes, functional ability, and health-related quality of life in patients with HF.

The effect of combined yoga and breathing training on the natural history of HF and its potential to decrease negative clinical outcomes and improve symptoms is unknown. The relevance of this research is related to the important information it will provide to clinicians caring for patients with HF and will be the basis for pilot data for future NIH funding applications.

Detailed description: The proposed research project is a pilot study designed to delineate the clinical outcomes associated with a modified yoga program in a population of adults with ventricular dysfunction and clinical heart failure (HF). The researchers hypothesize that patients in a modified yoga training program will have a significant improvement in clinical outcomes, functional ability, and health-related quality of life (HRQOL). The researchers propose to evaluate 15-20 subjects with chronic HF and New York Heart Association Functional Class (NYHA) II-III and obtain baseline physiological, functional, and HRQOL measurements. After obtaining baseline measurements, patients will participate in a modified yoga program with instruction for home practice for 8 weeks. Baseline measurements include: Vital signs, oxygen saturation, heart rate variability, exercise distance, muscular strength and flexibility determination, and various indices of HRQOL. At the conclusion of 8 weeks of yoga training the same measurements will be obtained.

In a group of chronic HF patients, the specific aims are the following:

1. To develop a safe and feasible yoga program;
2. To determine whether clinical outcomes (vital signs, oxygen saturation, heart rate variability), functional ability (exercise distance, muscular strength and flexibility determination), and HRQOL are positively affected by a modified yoga program.

Eligibility criteria: Inclusion Criteria:

* NYHA class I-III
* normal sinus rhythm
* able to walk
* ability to read or understand English
* age 30-75

Exclusion Criteria:

* cognitive impairment
* inability to consent
* 100% paced with pacemaker
* hospitalization within 3 months
* MI or recurrent angina within 6 months
* severe stenotic valve disease
* history of sudden cardiac death
* history of uncontrolled ventricular tachyarrhythmias
* pulmonary hypertension
* FEV1 less than 1 liter by spirometry
* orthopedic impediments to yoga
* medication noncompliance

Primary outcomes:
measure: Improvement in heart rate variability
timeFrame: 8 weeks
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 8 weeks
measure: muscle strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Osher Center and UCSF Cardiology Faculty Practice
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jill Howie-Esquivel, PhD
role: PRINCIPAL_INVESTIGATOR
References: