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The Effects of a Yoga Program in Heart Failure Patients

NCT ID: NCT00794027

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Keywords

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heart failure yoga quality of life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yoga group

Patients with heart failure

Group Type OTHER

Yoga Classes

Intervention Type BEHAVIORAL

8 weeks of yoga training that occurs 2 times per week. The patients will also perform yoga breathing at home 3 times per week.

Yoga classes

Intervention Type BEHAVIORAL

Heart failure patients will undergo 8 weeks of yoga training 2 times per week and perform yoga breathing at home 3 times per week

Interventions

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Yoga Classes

8 weeks of yoga training that occurs 2 times per week. The patients will also perform yoga breathing at home 3 times per week.

Intervention Type BEHAVIORAL

Yoga classes

Heart failure patients will undergo 8 weeks of yoga training 2 times per week and perform yoga breathing at home 3 times per week

Intervention Type BEHAVIORAL

Other Intervention Names

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breathing pranyama

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill Howie-Esquivel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Osher Center and UCSF Cardiology Faculty Practice

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H40997-33062-01

Identifier Type: -

Identifier Source: org_study_id