Clinical trial NCT01998724: Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Official title: Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic bronchitis
Emphysema
Pulmonary
COPD
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-12-02
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) \<0.70 or chest CT evidence of emphysema
2. Age \> 40 years
3. Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
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

Exclusion Criteria:

1. COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
2. Hypoxemia on walk test (O2 sat \< 85% on oxygen)
3. Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
4. Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
5. Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
6. Non-English speaking
7. Current regular practice of tai chi
8. Current diagnosis of lung cancer or treated for lung cancer within the past 5 years
9. Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention

Primary outcomes:
measure: Feasibility of tai chi intervention
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline - Disease specific quality of life
timeFrame: Baseline, 12 weeks, 24 weeks, 1 year
measure: Change from baseline - Exercise capacity
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline - Dyspnea
timeFrame: Baseline, 12 weeks, 24 weeks, 1 year
measure: Change from baseline - Psychosocial well-being
timeFrame: Baseline, 12 weeks, 24 weeks, 1 year
measure: Changes from baseline - Pulmonary function
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change from baseline - Exercise Efficacy
timeFrame: Throughout study
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Healthcare System
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: BIDMC, Harvard Medical School
name: Gloria Yeh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Moy 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.