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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01998724
Recruitment Status : Active, not recruiting
First Posted : December 2, 2013
Last Update Posted : January 8, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Tai Chi Behavioral: Group Walking

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Study Start Date : August 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Standard Care
No intervention
Experimental: Tai Chi Exercise
24 week Tai Chi intervention designed for individuals with COPD
Behavioral: Tai Chi
24 week tai chi intervention designed for individuals with COPD
Experimental: Group Walking Exercise
24 week group walking intervention
Behavioral: Group Walking
24 week group walking intervention


Outcome Measures

Primary Outcome Measures :
  1. Feasibility of tai chi intervention [ Time Frame: 24 weeks ]
    Willingness to participate, adherence, and safety


Secondary Outcome Measures :
  1. Change from baseline - Disease specific quality of life [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ]
    Chronic Respiratory Questionnaire

  2. Change from baseline - Exercise capacity [ Time Frame: Baseline, 12 weeks, 24 weeks ]
    Six minute walk distance

  3. Change from baseline - Dyspnea [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ]
    University of California, San Diego Shortness of Breath Questionnaire

  4. 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

  5. Changes from baseline - Pulmonary function [ Time Frame: Baseline, 12 weeks, 24 weeks ]
    Spirometry

  6. Change from baseline - Exercise Efficacy [ Time Frame: Throughout study ]
    Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998724


Locations
United States, Massachusetts
VA Healthcare System
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Gloria Yeh, MD, MPH BIDMC, Harvard Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01998724     History of Changes
Other Study ID Numbers: 2012P000220
R01AT006358 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2013    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Gloria Y. Yeh, Beth Israel Deaconess Medical Center:
Chronic bronchitis
Emphysema
Pulmonary
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases