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

Primary Purpose

Yoga, COPD, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Program at home using internet technology
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Yoga focused on measuring Yoga, COPD, Congestive Heart Failure

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga Program

Education

Arm Description

Yoga Program twice per week for 8 weeks

Education once per week for 8 weeks

Outcomes

Primary Outcome Measures

Feasibility of home yoga program as measured by the participants' perception of the quality of the broadband connection.
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.

Secondary Outcome Measures

Physical Function
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

Full Information

First Posted
February 24, 2014
Last Updated
January 26, 2015
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02078739
Brief Title
Tele-yoga Program in COPD and Heart Failure
Acronym
Tele-yoga
Official Title
Tele-Yoga for Chronic Obstructive Pulmonary Disease and Heart Failure Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yoga, COPD, Congestive Heart Failure
Keywords
Yoga, COPD, Congestive Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Program
Arm Type
Experimental
Arm Description
Yoga Program twice per week for 8 weeks
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Education once per week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Yoga Program at home using internet technology
Primary Outcome Measure Information:
Title
Feasibility of home yoga program as measured by the participants' perception of the quality of the broadband connection.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Physical Function
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill N Howie-Esquivel, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25887324
Citation
Selman L, McDermott K, Donesky D, Citron T, Howie-Esquivel J. Appropriateness and acceptability of a Tele-Yoga intervention for people with heart failure and chronic obstructive pulmonary disease: qualitative findings from a controlled pilot study. BMC Complement Altern Med. 2015 Feb 7;15:21. doi: 10.1186/s12906-015-0540-8.
Results Reference
derived

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Tele-yoga Program in COPD and Heart Failure

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