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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Behavioral: Tai Chi; Behavioral: Group Walking

• Registration Number: NCT01998724
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-02
• Primary Completion: 2018-01
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi Exercise	Tai Chi	24 week Tai Chi intervention designed for individuals with COPD
Group Walking Exercise	Group Walking	24 week group walking intervention

Primary Outcome Measures

Name	Time	Method
Feasibility of tai chi intervention	24 weeks	Willingness to participate, adherence, and safety

Secondary Outcome Measures

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

Trial Locations

Locations (2)

VA Healthcare System; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States