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

November 11, 2008
July 31, 2013
November 2008
May 2009   (final data collection date for primary outcome measure)
Improvement in heart rate variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794027 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effects of a Yoga Program in Heart Failure Patients
The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Yoga group
Patients with heart failure
Interventions:
  • Behavioral: Yoga Classes
  • Behavioral: Yoga classes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00794027
H40997-33062-01
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Jill Howie-Esquivel, PhD University of California, San Francisco
University of California, San Francisco
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP