Tele-yoga Program in COPD and Heart Failure

COPD Clinical Trial

— Tele-yoga  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078739
• Other study ID #: 12-08383
• Secondary ID: Tele-Yoga
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: January 26, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congestive Heart Failure
• COPD
• Heart Failure
• Yoga

Intervention

Behavioral:
• Yoga Program at home using internet technology

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	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	8 weeks	No