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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
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
  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:


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
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: 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
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014