Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
LEAP
2 other identifiers
interventional
90
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
2 active sites
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
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedOctober 3, 2018
October 1, 2018
5.4 years
November 25, 2013
October 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of tai chi intervention
Willingness to participate, adherence, and safety
24 weeks
Secondary Outcomes (6)
Change from baseline - Disease specific quality of life
Baseline, 12 weeks, 24 weeks, 1 year
Change from baseline - Exercise capacity
Baseline, 12 weeks, 24 weeks
Change from baseline - Dyspnea
Baseline, 12 weeks, 24 weeks, 1 year
Change from baseline - Psychosocial well-being
Baseline, 12 weeks, 24 weeks, 1 year
Changes from baseline - Pulmonary function
Baseline, 12 weeks, 24 weeks
- +1 more secondary outcomes
Study Arms (3)
Standard Care
NO INTERVENTIONNo intervention
Tai Chi Exercise
EXPERIMENTAL24 week Tai Chi intervention designed for individuals with COPD
Group Walking Exercise
EXPERIMENTAL24 week group walking intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Healthcare System
Boston, Massachusetts, 02130, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
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.
PMID: 34023739DERIVEDMoy 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.
PMID: 26362690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gloria Yeh, MD, MPH
BIDMC, Harvard Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 2, 2013
Study Start
August 1, 2012
Primary Completion
January 1, 2018
Study Completion
September 1, 2018
Last Updated
October 3, 2018
Record last verified: 2018-10