NCT02078739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

February 24, 2014

Last Update Submit

January 26, 2015

Conditions

YogaCOPDCongestive Heart Failure

Keywords

YogaCOPDCongestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Physical Function

    8 weeks

Study Arms (2)

Yoga Program

EXPERIMENTAL

Yoga Program twice per week for 8 weeks

Behavioral: Yoga Program at home using internet technology

Education

ACTIVE COMPARATOR

Education once per week for 8 weeks

Behavioral: Yoga Program at home using internet technology

Interventions

Yoga Program at home using internet technologyBEHAVIORAL
EducationYoga Program

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

    PMID: 25887324DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Jill N Howie-Esquivel, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 5, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

US(1)