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Clinical Trials/NCT01998724
NCT01998724
Completed
Not Applicable

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

Beth Israel Deaconess Medical Center2 sites in 1 country90 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
90
Locations
2
Primary Endpoint
Feasibility of tai chi intervention
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
September 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gloria Y. Yeh

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility of tai chi intervention

Time Frame: 24 weeks

Willingness to participate, adherence, and safety

Secondary Outcomes

  • Change from baseline - Dyspnea(Baseline, 12 weeks, 24 weeks, 1 year)
  • Change from baseline - Exercise Efficacy(Throughout study)
  • Changes from baseline - Pulmonary function(Baseline, 12 weeks, 24 weeks)
  • Change from baseline - Exercise capacity(Baseline, 12 weeks, 24 weeks)
  • Change from baseline - Disease specific quality of life(Baseline, 12 weeks, 24 weeks, 1 year)
  • Change from baseline - Psychosocial well-being(Baseline, 12 weeks, 24 weeks, 1 year)

Study Sites (2)

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