Chronic Obstructive Pulmonary Disease (COPD)LEAPNCT01998724
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
A study testing Tai Chi and Group Walking in people with Chronic Obstructive Pulmonary Disease (COPD), run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tai Chi and Group Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) <0.70 or chest CT evidence of emphysema
- Age > 40 years
- Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
- Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry* *Defined as attending 65% of the program's sessions with a minimum of 10 sessions
Who cannot join
- COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
- Hypoxemia on walk test (O2 sat < 85% on oxygen)
- Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
- Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
- Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
- Non-English speaking
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- Current regular practice of tai chi
- Current diagnosis of lung cancer or treated for lung cancer within the past 5 years
- Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Healthcare System
Boston, Massachusetts, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.
- Being tested
- Tai Chi, Group Walking
- Keywords
- Chronic bronchitis, Emphysema, Pulmonary, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
24 week tai chi intervention designed for individuals with COPD
Group WalkingBehavioural
24 week group walking intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | No intervention |
| Tai Chi Exercise | Experimental | 24 week Tai Chi intervention designed for individuals with COPD Receives: Behavioral: Tai Chi |
| Group Walking Exercise | Experimental | 24 week group walking intervention Receives: Behavioral: Group Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of tai chi intervention
Willingness to participate, adherence, and safety
Measured: 24 weeks
Secondary outcomes (6)
Change from baseline - Disease specific quality of life
Chronic Respiratory Questionnaire
Measured: Baseline, 12 weeks, 24 weeks, 1 year
Change from baseline - Exercise capacity
Six minute walk distance
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline - Dyspnea
University of California, San Diego Shortness of Breath Questionnaire
Measured: Baseline, 12 weeks, 24 weeks, 1 year
Change from baseline - Psychosocial well-being
Center for Epidemiologic Studies Depression Scale, Perceived Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Perceived Social Support
Measured: Baseline, 12 weeks, 24 weeks, 1 year
Changes from baseline - Pulmonary function
Spirometry
Measured: Baseline, 12 weeks, 24 weeks
Change from baseline - Exercise Efficacy
Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionJan 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
- Investigators
- Gloria Yeh, MD, MPH, Principal investigator, BIDMC, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998724
- Sponsor's protocol ID
- 2012P000220
- Other IDs
- R01AT006358
- Acronym
- LEAP
- Status last verified
- Oct 2018
- First submitted
- 25 Nov 2013
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gilliam EA, Kilgore KL, Liu Y, Bernier L, Criscitiello S, Litrownik D, Wayne PM, Moy ML, Yeh GY. Managing the experience of breathlessness with Tai Chi: A qualitative analysis from a randomized controlled trial in COPD. Respir Med. 2021 Aug;184:106463. doi: 10.1016/j.rmed.2021.106463. Epub 2021 May 15.
PubMed 34023739Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 8.
PubMed 26362690
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01998724
- Acronym / sponsor ID
- LEAP / 2012P000220
- Keywords
- Chronic bronchitis, Emphysema, Pulmonary, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Dec 2013 (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 main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –No intervention |
| Tai Chi Exercise | Experimental | Behavioral: Tai Chi24 week Tai Chi intervention designed for individuals with COPD |
| Group Walking Exercise | Experimental | Behavioral: Group Walking24 week group walking intervention |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) <0.70 or chest CT evidence of emphysema
- Age > 40 years
- Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
- Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry* *Defined as attending 65% of the program's sessions with a minimum of 10 sessions
Key exclusion criteria (9 listed)
- COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
- Hypoxemia on walk test (O2 sat < 85% on oxygen)
- Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
- Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
- Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
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 |
|---|---|---|
| Tai Chi24 week tai chi intervention designed for individuals with COPD | Behavioural | Tai Chi Exercise |
| Group Walking24 week group walking intervention | Behavioural | Group Walking Exercise |
Primary outcome
Feasibility of tai chi intervention
Time frame: 24 weeks
Willingness to participate, adherence, and safety
6 secondary outcomes
Change from baseline - Disease specific quality of life
Time frame: Baseline, 12 weeks, 24 weeks, 1 year
Change from baseline - Exercise capacity
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline - Dyspnea
Time frame: Baseline, 12 weeks, 24 weeks, 1 year
Change from baseline - Psychosocial well-being
Time frame: Baseline, 12 weeks, 24 weeks, 1 year
Changes from baseline - Pulmonary function
Time frame: Baseline, 12 weeks, 24 weeks
Change from baseline - Exercise Efficacy
Time frame: Throughout study
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 3 Oct 2018.
- Derived from this study: PubMed 34023739Gilliam EA, Kilgore KL, Liu Y, Bernier L, Criscitiello S, Litrownik D, Wayne PM, Moy ML, Yeh GY. Managing the experience of breathlessness with Tai Chi: A qualitative analysis from a randomized controlled trial in COPD. Respir Med. 2021 Aug;184:106463. doi: 10.1016/j.rmed.2021.106463. Epub 2021 May 15.
- Derived from this study: PubMed 26362690Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 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.
Gloria Yeh, MD, MPH principal investigator
BIDMC, Harvard Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Group Walking in people with Chronic Obstructive Pulmonary Disease (COPD), run by Beth Israel Deaconess Medical Center at 2 sites 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 4 inclusion and 9 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 tai chi intervention (time frame: 24 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 NCT01998724, which also lists 2 linked publications.
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 3 Oct 2018.