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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


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
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