search
Back to results

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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Classes
Yoga classes
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, yoga, quality of life

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Osher Center and UCSF Cardiology Faculty Practice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Yoga group

Arm Description

Patients with heart failure

Outcomes

Primary Outcome Measures

Improvement in heart rate variability

Secondary Outcome Measures

Health-related quality of life
muscle strength

Full Information

First Posted
November 11, 2008
Last Updated
July 31, 2013
Sponsor
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT00794027
Brief Title
The Effects of a Yoga Program in Heart Failure Patients
Acronym
YOGA
Official Title
The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, yoga, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Other
Arm Description
Patients with heart failure
Intervention Type
Behavioral
Intervention Name(s)
Yoga Classes
Other Intervention Name(s)
breathing
Intervention Description
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
Intervention Name(s)
Yoga classes
Other Intervention Name(s)
pranyama
Intervention Description
Heart failure patients will undergo 8 weeks of yoga training 2 times per week and perform yoga breathing at home 3 times per week
Primary Outcome Measure Information:
Title
Improvement in heart rate variability
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life
Time Frame
8 weeks
Title
muscle strength
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Howie-Esquivel, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Osher Center and UCSF Cardiology Faculty Practice
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of a Yoga Program in Heart Failure Patients

We'll reach out to this number within 24 hrs