Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic bronchitis, Emphysema, Pulmonary, COPD
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.
Interventions
BEHAVIORALTai Chi
24 week tai chi intervention designed for individuals with COPD
BEHAVIORALGroup Walking
24 week group walking intervention
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of tai chi intervention | 24 weeks | Willingness to participate, adherence, and safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline - Exercise capacity | Baseline, 12 weeks, 24 weeks | Six minute walk distance |
| Change from baseline - Dyspnea | Baseline, 12 weeks, 24 weeks, 1 year | University of California, San Diego Shortness of Breath Questionnaire |
| Change from baseline - Disease specific quality of life | Baseline, 12 weeks, 24 weeks, 1 year | Chronic Respiratory Questionnaire |
| Changes from baseline - Pulmonary function | Baseline, 12 weeks, 24 weeks | Spirometry |
| Change from baseline - Exercise Efficacy | Throughout study | Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year |
| Change from baseline - Psychosocial well-being | Baseline, 12 weeks, 24 weeks, 1 year | Center for Epidemiologic Studies Depression Scale, Perceived Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Perceived Social Support |
Countries
United States
Outcome results
None listed