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BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)

This study is currently recruiting participants.
Verified March 2012 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01551953
First received: March 1, 2012
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Behavioral: Tai chi
Behavioral: Mind-body breathing
Behavioral: Education
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Feasibility of tai chi intervention [ Time Frame: 12 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 ] [ 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, cardiopulmonary exercise testing

  • Change from baseline- Dyspnea [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    UCSD Shortness of Breath Questionnaire

  • Change from baseline- Psychosocial well-being [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    CES-D, Perceived Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Percieved Social Support

  • Change from baseline- Pulmonary function [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Spirometry and lung volumes

  • Change from baseline- Physical strength and flexibility [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    Chair Sit and Reach, Chair Stand


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tai chi exercise Behavioral: Tai chi
12 week tai chi class
Experimental: mind-body breathing Behavioral: Mind-body breathing
12 week breathing class
Active Comparator: education Behavioral: Education
12 week education class

  Eligibility

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

Inclusion Criteria:

  1. Moderate-severe COPD
  2. Age ≥ 40 years

Exclusion Criteria:

  1. Subjects with respiratory failure or GOLD stage 4 who are unable to safely perform a 6 minute walk test or otherwise safely exercise as deemed by a physician.
  2. COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
  3. Planned major pulmonary intervention within the next 3 months
  4. Hypoxemia on walk test or cardiopulmonary exercise test
  5. Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
  6. Clinical signs of unstable cardiovascular disease
  7. Severe cognitive dysfunction
  8. Non-English speaking
  9. Current active participation in pulmonary rehabilitation program or current regular practice of tai chi
  10. Physician diagnosis of unstable/untreated clinical depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551953

Contacts
Contact: Daniel Litrownik 617-754-1423 dlitrown@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Gloria Yeh, MD, MPH            
VA Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Marilyn Moy, MD     857-203-5126        
Principal Investigator: Marilyn Moy, MD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
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: NCT01551953     History of Changes
Other Study ID Numbers: 2010P-000412, R01AT005436
Study First Received: March 1, 2012
Last Updated: March 9, 2012
Health Authority: United States: Institutional Review 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 May 21, 2013