Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

Study Overview
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Brief Summary
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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.

Official Title
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Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Behavioral: Tai Chi
* Behavioral: Group Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>No intervention | |
| Experimental: Tai Chi Exercise<br>24 week Tai Chi intervention designed for individuals with COPD | Behavioral: Tai Chi<br>* 24 week tai chi intervention designed for individuals with COPD<br>|
| Experimental: Group Walking Exercise<br>24 week group walking intervention | Behavioral: Group Walking<br>* 24 week group walking intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of tai chi intervention | Willingness to participate, adherence, and safety | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline - Disease specific quality of life | Chronic Respiratory Questionnaire | Baseline, 12 weeks, 24 weeks, 1 year | 
| Change from baseline - Exercise capacity | Six minute walk distance | Baseline, 12 weeks, 24 weeks | 
| Change from baseline - Dyspnea | University of California, San Diego Shortness of Breath Questionnaire | 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 | Baseline, 12 weeks, 24 weeks, 1 year | 
| Changes from baseline - Pulmonary function | Spirometry | Baseline, 12 weeks, 24 weeks | 
| Change from baseline - Exercise Efficacy | Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic bronchitis, Emphysema, Pulmonary, COPD