Pulmonary Disease, Chronic ObstructivePhase 1/2NCT00051792
Yoga for Treating Shortness of Breath in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1/2 study testing yoga in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema
- What is being tested?
- yoga
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jul 2004
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to commit to a 12-week yoga class in San Francisco, California
- Moderate to severe COPD, clinically stable for at least 1 month prior to study entry
- Forced Expiratory Volume at one minute (FEV1) < 49% predicted after inhaled bronchodilator
- Activities of daily living limited by shortness of breath
- Ability to speak English and sign consent
- Patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at > 85% on < 6 L/min of nasal oxygen
Who cannot join
- Symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness)
- Formal pulmonary rehabilitation training within 1 year prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Yoga for Self-Management of Dyspnea in COPD
The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath.
Read the detailed description
Management of dyspnea (shortness of breath) is a major concern for patients with COPD. The efficacy of complementary exercises to manage dyspnea is unknown. Complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. Yoga practice is a complementary therapy that people use to manage their dyspnea. The aims of this study are to: 1) develop a safe and feasible yoga program for patients with COPD; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice.
Patients in this study will be randomized to receive yoga training or usual care for 12 weeks. Patients will be evaluated at study entry, after each session, and immediately after the training program.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Chronic Bronchitis
- Being tested
- yoga
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2003 (estimated)
- Study startJan 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Virginia Carrieri-Kohlman, RN, DNSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051792
- Sponsor's protocol ID
- R21AT001168-01
- Status last verified
- Aug 2006
- First submitted
- 16 Jan 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Yoga for Self-Management of Dyspnea in COPD
- ClinicalTrials.gov ID
- NCT00051792
- Acronym / sponsor ID
- R21AT001168-01
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Chronic Bronchitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jan 2003
- Study completion
- Jul 2004
- First posted
- 17 Jan 2003 (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 purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath.
Detailed description
Management of dyspnea (shortness of breath) is a major concern for patients with COPD. The efficacy of complementary exercises to manage dyspnea is unknown. Complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. Yoga practice is a complementary therapy that people use to manage their dyspnea. The aims of this study are to: 1) develop a safe and feasible yoga program for patients with COPD; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice.
Patients in this study will be randomized to receive yoga training or usual care for 12 weeks. Patients will be evaluated at study entry, after each session, and immediately after the training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to commit to a 12-week yoga class in San Francisco, California
- Moderate to severe COPD, clinically stable for at least 1 month prior to study entry
- Forced Expiratory Volume at one minute (FEV1) < 49% predicted after inhaled bronchodilator
- Activities of daily living limited by shortness of breath
- Ability to speak English and sign consent
Key exclusion criteria (2 listed)
- Symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness)
- Formal pulmonary rehabilitation training within 1 year prior to study entry
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 | Behavioural | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Virginia Carrieri-Kohlman, RN, DNSc 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 Phase 1/2 study testing yoga in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by National Center for Complementary and Integrative Health (NCCIH) 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 6 inclusion and 2 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 18 Aug 2006. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 18 Aug 2006.