NCT00794027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

November 11, 2008

Last Update Submit

July 31, 2013

Conditions

Keywords

heart failureyogaquality of life

Outcome Measures

Primary Outcomes (1)

  • Improvement in heart rate variability

    8 weeks

Secondary Outcomes (2)

  • Health-related quality of life

    8 weeks

  • muscle strength

    8 weeks

Study Arms (1)

Yoga group

OTHER

Patients with heart failure

Behavioral: Yoga Classes

Interventions

Yoga classesBEHAVIORAL

8 weeks of yoga training that occurs 2 times per week. The patients will also perform yoga breathing at home 3 times per week.

Also known as: breathing
Yoga group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA class I-III
  • normal sinus rhythm
  • able to walk
  • ability to read or understand English
  • age 30-75

You may not qualify if:

  • cognitive impairment
  • inability to consent
  • % 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Osher Center and UCSF Cardiology Faculty Practice

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Respiration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Jill Howie-Esquivel, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

December 1, 2009

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations