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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	124 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Other
Official Title:	BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
Study Start Date :	February 2011
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Feasibility of tai chi intervention [ Time Frame: 12 weeks ]
   Willingness to participate, adherence, and safety

Secondary Outcome Measures :

1. Change from baseline- Disease specific quality of life [ Time Frame: baseline, 12 weeks, 24 weeks ]
   Chronic Respiratory Questionnaire
2. Change from baseline- Exercise capacity [ Time Frame: baseline, 12 weeks, 24 weeks ]
   six-minute walk distance, cardiopulmonary exercise testing
3. Change from baseline- Dyspnea [ Time Frame: baseline, 12 weeks, 24 weeks ]
   UCSD Shortness of Breath Questionnaire
4. 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
5. Change from baseline- Pulmonary function [ Time Frame: baseline, 12 weeks, 24 weeks ]
   Spirometry and lung volumes
6. Change from baseline- Physical strength and flexibility [ Time Frame: baseline, 12 weeks, 24 weeks ]
   Chair Sit and Reach, Chair Stand

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 ( U.S. NIH Grant/Contract )
First Posted:	March 13, 2012
Last Update Posted:	February 27, 2017
Last Verified:	February 2017

Keywords provided by Gloria Y. Yeh, 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