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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01551953
First received: March 1, 2012
Last updated: February 23, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Other
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 ]
    Willingness to participate, adherence, and safety


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

  • Change from baseline- Exercise capacity [ Time Frame: baseline, 12 weeks, 24 weeks ]
    six-minute walk distance, cardiopulmonary exercise testing

  • Change from baseline- Dyspnea [ Time Frame: baseline, 12 weeks, 24 weeks ]
    UCSD Shortness of Breath Questionnaire

  • Change from baseline- Psychosocial well-being [ Time Frame: baseline, 12 weeks, 24 weeks ]
    CES-D, Perceive Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Percieved Social Support

  • Change from baseline- Pulmonary function [ Time Frame: baseline, 12 weeks, 24 weeks ]
    Spirometry and lung volumes

  • Change from baseline- Physical strength and flexibility [ Time Frame: baseline, 12 weeks, 24 weeks ]
    Chair Sit and Reach, Chair Stand


Enrollment: 124
Study Start Date: February 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
  11. History of lung cancer
  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

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: NCT01551953     History of Changes
Other Study ID Numbers: 2010P000412
R01AT005436 ( US NIH Grant/Contract Award Number )
Study First Received: March 1, 2012
Last Updated: February 23, 2017

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 April 21, 2017