Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 8:01 PM
Study NCT ID:
NCT00794027
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2008-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Yoga Program in Heart Failure Patients
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
The Clinical Outcomes Associated With a Modified Yoga Program in Heart Failure
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YOGA
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.
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: