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

This study is currently recruiting participants.
Verified February 2017 by Gloria Y. Yeh, Beth Israel Deaconess Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01998724
First Posted: December 2, 2013
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
November 25, 2013
December 2, 2013
February 27, 2017
August 2012
September 2017   (Final data collection date for primary outcome measure)
Feasibility of tai chi intervention [ Time Frame: 24 weeks ]
Willingness to participate, adherence, and safety
Same as current
Complete list of historical versions of study NCT01998724 on ClinicalTrials.gov Archive Site
  • Change from baseline - Disease specific quality of life [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ]
    Chronic Respiratory Questionnaire
  • Change from baseline - Exercise capacity [ Time Frame: Baseline, 12 weeks, 24 weeks ]
    Six minute walk distance
  • Change from baseline - Dyspnea [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ]
    University of California, San Diego Shortness of Breath Questionnaire
  • Change from baseline - Psychosocial well-being [ Time Frame: 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
  • Changes from baseline - Pulmonary function [ Time Frame: Baseline, 12 weeks, 24 weeks ]
    Spirometry
  • Change from baseline - Exercise Efficacy [ Time Frame: Throughout study ]
    Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year
Same as current
Not Provided
Not Provided
 
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Chronic Obstructive Pulmonary Disease (COPD)
  • Behavioral: Tai Chi
    24 week tai chi intervention designed for individuals with COPD
  • Behavioral: Group Walking
    24 week group walking intervention
  • No Intervention: Standard Care
    No intervention
  • Experimental: Tai Chi Exercise
    24 week Tai Chi intervention designed for individuals with COPD
    Intervention: Behavioral: Tai Chi
  • Experimental: Group Walking Exercise
    24 week group walking intervention
    Intervention: Behavioral: Group Walking
Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
September 2017
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact: Daniel Litrownik, BA 617-754-1423 dlitrown@bidmc.harvard.edu
Contact: Caroline Chan, BA 617-754-1458 cchan5@caregroup.org
United States
 
 
NCT01998724
2012P000220
R01AT006358 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • National Institutes of Health (NIH)
  • National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Gloria Yeh, MD, MPH BIDMC, Harvard Medical School
Beth Israel Deaconess Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP