The Effects of a Yoga Program in Heart Failure Patients

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Yoga Classes
* Behavioral: Yoga classes


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Yoga group<br>Patients with heart failure | Behavioral: Yoga Classes<br>* 8 weeks of yoga training that occurs 2 times per week. The patients will also perform yoga breathing at home 3 times per week.<br>* Other names: breathing;Behavioral: Yoga classes<br>* Heart failure patients will undergo 8 weeks of yoga training 2 times per week and perform yoga breathing at home 3 times per week<br>* Other names: pranyama;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in heart rate variability |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | 8 weeks | 
| muscle strength |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, yoga, quality of life