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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01998724
First received: November 25, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: Tai Chi
Behavioral: Group Walking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Feasibility of tai chi intervention [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Willingness to participate, adherence, and safety


Secondary Outcome Measures:
  • Change from baseline - Disease specific quality of life [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ] [ Designated as safety issue: No ]
    Chronic Respiratory Questionnaire

  • Change from baseline - Exercise capacity [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Six minute walk distance

  • Change from baseline - Dyspnea [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ] [ Designated as safety issue: No ]
    University of California, San Diego Shortness of Breath Questionnaire

  • Change from baseline - Psychosocial well-being [ Time Frame: Baseline, 12 weeks, 24 weeks, 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Spirometry

  • Change from baseline - Exercise Efficacy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
    Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. COPD defined as FEV1 (Forced exiratory 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
  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. History of lung cancer
  9. Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998724

Contacts
Contact: Daniel Litrownik, BA 617-754-1423 dlitrown@bidmc.harvard.edu
Contact: Caroline Chan, BA 617-754-1458 cchan5@caregroup.org

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
VA Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Marilyn Moy, MD    857-203-5126    marilyn.moy@va.gov   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Gloria Yeh, MD, MPH BIDMC, Harvard Medical School
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01998724     History of Changes
Other Study ID Numbers: 2012P-000220, R01AT006358
Study First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 22, 2014