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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Beth Israel Deaconess Medical Center

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01551953

First received: March 1, 2012

Last updated: February 16, 2015

Last verified: February 2015

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:

MedlinePlus related topics: COPD Lung Diseases

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, 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 ] [ 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:	November 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:

Moderate-severe COPD
Age ≥ 40 years

Exclusion Criteria:

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.
COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
Planned major pulmonary intervention within the next 3 months
Hypoxemia on walk test or cardiopulmonary exercise test
Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
Clinical signs of unstable cardiovascular disease
Severe cognitive dysfunction
Non-English speaking
Current active participation in pulmonary rehabilitation program or current regular practice of tai chi
Physician diagnosis of unstable/untreated clinical depression
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

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 Integrative Health (NCCIH)

Investigators


Principal Investigator:	Gloria Yeh, MD, MPH	BIDMC, Harvard Medical School

More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional 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:	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:	February 16, 2015
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 Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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