YogaTele-yogaNCT02078739
Tele-yoga Program in COPD and Heart Failure
A study testing Yoga Program at home using internet technology in people with Yoga and COPD, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Yoga, COPD, Congestive Heart Failure
- What is being tested?
- Yoga Program at home using internet technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Tele-Yoga for Chronic Obstructive Pulmonary Disease and Heart Failure Patients: A Pilot Study
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.
- Conditions
- Yoga, COPD, Congestive Heart Failure
- Being tested
- Yoga Program at home using internet technology
- Keywords
- Yoga, COPD, Congestive Heart Failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Program at home using internet technologyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Yoga Program | Experimental | Yoga Program twice per week for 8 weeks Receives: Behavioral: Yoga Program at home using internet technology |
| Education | Active comparator | Education once per week for 8 weeks Receives: Behavioral: Yoga Program at home using internet technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill N Howie-Esquivel, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078739
- Sponsor's protocol ID
- 12-08383
- Other IDs
- Tele-Yoga
- Acronym
- Tele-yoga
- Status last verified
- Jan 2015
- First submitted
- 24 Feb 2014
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25887324
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Yoga for Chronic Obstructive Pulmonary Disease and Heart Failure Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT02078739
- Acronym / sponsor ID
- Tele-yoga / 12-08383
- Conditions
- Yoga, COPD, Congestive Heart Failure
- Keywords
- Yoga, COPD, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Program | Experimental | Behavioral: Yoga Program at home using internet technologyYoga Program twice per week for 8 weeks |
| Education | Active comparator | Behavioral: Yoga Program at home using internet technologyEducation once per week for 8 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Program at home using internet technology | Behavioural | Education, Yoga Program |
Primary outcome
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.
1 secondary outcome
Physical Function
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Derived from this study: PubMed 25887324Selman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill N Howie-Esquivel, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Program at home using internet technology in people with Yoga and COPD, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of home yoga program as measured by the participants' perception of the quality of the broadband connection. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.