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

• ClinicalTrials.gov Identifier: NCT02078739
• Recruitment Status: Completed
• First Posted: March 5, 2014
• Last Update Posted: January 27, 2015
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

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.

Condition or disease	Intervention/treatment	Phase
Yoga; COPD; Congestive Heart Failure	Behavioral: Yoga Program at home using internet technology	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Tele-Yoga for Chronic Obstructive Pulmonary Disease and Heart Failure Patients: A Pilot Study
• Study Start Date: June 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02078739
• Other Study ID Numbers: 12-08383; Tele-Yoga ( Other Grant/Funding Number: UCSF School of Nursing )
• First Posted: March 5, 2014
• Last Update Posted: January 27, 2015
• Last Verified: January 2015

Keywords provided by University of California, San Francisco:

Yoga; COPD; Congestive Heart Failure

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases