Trial record 6 of 17 for:    bronchitis | Open Studies | NIH, U.S. Fed

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

This study is currently recruiting participants.
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
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014