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Completed

NCT Number: NCT00794027

The Effects of a Yoga Program in Heart Failure Patients

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Osher Center and UCSF Cardiology Faculty Practice

San Francisco, California, 94143, United States

About this study

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:

  • To develop a safe and feasible yoga program;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga classes

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.

Other names: breathing

Primary outcomes

  1. Improvement in heart rate variability

    Time frame: 8 weeks

Secondary outcomes

  1. Health-related quality of life

    Time frame: 8 weeks

  2. muscle strength

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure

Acronym: YOGA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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