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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— LEAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998724
• Other study ID #: 2012P000220
• Secondary ID: R01AT006358
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Tai Chi
24 week tai chi intervention designed for individuals with COPD
• Group Walking
24 week group walking intervention

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	VA Healthcare System	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of tai chi intervention	Willingness to participate, adherence, and safety	24 weeks
Secondary	Change from baseline - Disease specific quality of life	Chronic Respiratory Questionnaire	Baseline, 12 weeks, 24 weeks, 1 year
Secondary	Change from baseline - Exercise capacity	Six minute walk distance	Baseline, 12 weeks, 24 weeks
Secondary	Change from baseline - Dyspnea	University of California, San Diego Shortness of Breath Questionnaire	Baseline, 12 weeks, 24 weeks, 1 year
Secondary	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
Secondary	Changes from baseline - Pulmonary function	Spirometry	Baseline, 12 weeks, 24 weeks
Secondary	Change from baseline - Exercise Efficacy	Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year	Throughout study