The Effects of a Yoga Program in Heart Failure Patients (YOGA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00794027
First received: November 11, 2008
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Yoga Classes
Behavioral: Yoga classes

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Improvement in heart rate variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • muscle strength [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Yoga group
Patients with heart failure
Behavioral: 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.
Other Name: breathing
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
Other Name: pranyama

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794027

Locations
United States, California
UCSF Osher Center and UCSF Cardiology Faculty Practice
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jill Howie-Esquivel, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00794027     History of Changes
Other Study ID Numbers: H40997-33062-01
Study First Received: November 11, 2008
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
heart failure
yoga
quality of life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014