Tele-yoga Program in COPD and Heart Failure (Tele-yoga)

January 26, 2015 updated by: University of California, San Francisco

Tele-Yoga for Chronic Obstructive Pulmonary Disease and Heart Failure Patients: A Pilot Study

The combined diagnosis of chronic obstructive pulmonary disease (COPD) and heart failure (HF) is common but often missed because of similarities in clinical presentation, risk factors, and patient characteristics. The concurrent presence of both diseases worsens the limitations in exercise capacity and quality of life that patients experience with either disease alone. This pilot study will test the feasibility of a yoga program conducted in patients' homes using multi-point interactive videoconferencing ("Tele- Yoga") for patients with combined COPD/HF diagnoses. The investigators hypothesize that patients who receive a yoga program at home, compared to an educational control group, will experience fewer physical symptoms and better quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with heart failure (HF) who also have COPD according to University of California San Francisco medical record documentation and would like to participate in a home yoga intervention and hospitalization within the past 24 months.
  • Patients must: receive permission from their provider to participate in the study
  • English-speaking
  • Score of 3 on the Mini-Cog test
  • Be between the ages of 40 and 85 years
  • New York Heart Association Class I-III left ventricular systolic or diastolic HF
  • Have moderate-severe COPD defined as post bronchodilator Forced Expiratory Volume (FEV1) in 1 sec < 80% predicted, FEV1/Forced Vital Capacity ratio < 70% and history of smoking
  • TV, broadband internet connection, enough space to practice yoga in front of the TV, and willing to have research assistant install videoconferencing equipment.

Exclusion Criteria:

  • Patients with a history of medication non-compliance as described by their provider
  • Hospitalization within the last 3 months
  • Myocardial infarction or recurrent angina within the last 6 months
  • Severe stenotic valvular disease
  • History of sudden cardiac death without subsequent automatic internal defibrillator placement
  • Cognitive impairment
  • Neuromuscular, orthopedic, or psychiatric illness that would interfere with yoga training
  • Oxygen saturation <85% on 6 liters of nasal oxygen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga Program
Yoga Program twice per week for 8 weeks
Behavioral: Yoga Program at home using internet technology
Active Comparator: Education
Education once per week for 8 weeks
Behavioral: Yoga Program at home using internet technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of home yoga program as measured by the participants' perception of the quality of the broadband connection.
Time Frame: 8 weeks
To evaluate the feasibility, acceptability, adherence rate of an 8-week, 1-hr biweekly Tele-Yoga intervention. Feasibility will be determined by the quality of the broadband connection, acceptability measured by participant satisfaction with the Yoga program and adherence measured by the number of times a participant participates in the yoga program.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function
Time Frame: 8 weeks
Estimate the effect of home-based Tele-Yoga on physical function (endurance, balance, strength, and activity) and symptoms (dyspnea, sleep, and fatigue) compared to attention control
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Jill N Howie-Esquivel, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-08383
  • Tele-Yoga (Other Grant/Funding Number: UCSF School of Nursing)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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