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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:
ClinicalTrials.gov Identifier:
NCT01551953
First Posted: March 13, 2012
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
March 1, 2012
March 13, 2012
February 27, 2017
February 2011
April 2016   (Final data collection date for primary outcome measure)
Feasibility of tai chi intervention [ Time Frame: 12 weeks ]
Willingness to participate, adherence, and safety
Same as current
Complete list of historical versions of study NCT01551953 on ClinicalTrials.gov Archive Site
  • 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
  • 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, 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 ]
    Spirometry and lung volumes
  • Change from baseline- Physical strength and flexibility [ Time Frame: baseline, 12 weeks, 24 weeks ]
    Chair Sit and Reach, Chair Stand
Not Provided
Not Provided
 
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Chronic Obstructive Pulmonary Disease (COPD)
  • Behavioral: Tai chi
    12 week tai chi class
  • Behavioral: Mind-body breathing
    12 week breathing class
  • Behavioral: Education
    12 week education class
  • Experimental: tai chi exercise
    Intervention: Behavioral: Tai chi
  • Experimental: mind-body breathing
    Intervention: Behavioral: Mind-body breathing
  • Active Comparator: education
    Intervention: Behavioral: Education
Yeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:337. doi: 10.1186/1745-6215-15-337.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01551953
2010P000412
R01AT005436 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • National Institutes of Health (NIH)
  • National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Gloria Yeh, MD, MPH BIDMC, Harvard Medical School
Beth Israel Deaconess Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP