Back to resultsBEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD) (BEAM COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tai chi
Mind-body breathing
Education
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring chronic bronchitis, emphysema, pulmonary, COPD
Eligibility 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
Sites / Locations
- VA Healthcare System
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
tai chi exercise
mind-body breathing
education
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of tai chi intervention
Willingness to participate, adherence, and safety
Secondary Outcome Measures
Change from baseline- Disease specific quality of life
Chronic Respiratory Questionnaire
Change from baseline- Exercise capacity
six-minute walk distance, cardiopulmonary exercise testing
Change from baseline- Dyspnea
UCSD Shortness of Breath Questionnaire
Change from baseline- Psychosocial well-being
CES-D, Perceive Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Percieved Social Support
Change from baseline- Pulmonary function
Spirometry and lung volumes
Change from baseline- Physical strength and flexibility
Chair Sit and Reach, Chair Stand
Full Information
NCT ID
NCT01551953
First Posted
March 1, 2012
Last Updated
February 23, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01551953
Brief Title
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
BEAM COPD
Official Title
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
chronic bronchitis, emphysema, pulmonary, COPD
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tai chi exercise
Arm Type
Experimental
Arm Title
mind-body breathing
Arm Type
Experimental
Arm Title
education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tai chi
Intervention Description
12 week tai chi class
Intervention Type
Behavioral
Intervention Name(s)
Mind-body breathing
Intervention Description
12 week breathing class
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
12 week education class
Primary Outcome Measure Information:
Title
Feasibility of tai chi intervention
Description
Willingness to participate, adherence, and safety
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline- Disease specific quality of life
Description
Chronic Respiratory Questionnaire
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline- Exercise capacity
Description
six-minute walk distance, cardiopulmonary exercise testing
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline- Dyspnea
Description
UCSD Shortness of Breath Questionnaire
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline- Psychosocial well-being
Description
CES-D, Perceive Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Percieved Social Support
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline- Pulmonary function
Description
Spirometry and lung volumes
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline- Physical strength and flexibility
Description
Chair Sit and Reach, Chair Stand
Time Frame
baseline, 12 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Yeh, MD, MPH
Organizational Affiliation
BIDMC, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33831022
Citation
Gilliam EA, Cheung T, Kraemer K, Litrownik D, Wayne PM, Moy ML, Yeh GY. The impact of Tai Chi and mind-body breathing in COPD: Insights from a qualitative sub-study of a randomized controlled trial. PLoS One. 2021 Apr 8;16(4):e0249263. doi: 10.1371/journal.pone.0249263. eCollection 2021.
Results Reference
derived
PubMed Identifier
33219007
Citation
Yeh GY, Litrownik D, Wayne PM, Beach D, Klings ES, Reyes Nieva H, Pinheiro A, Davis RB, Moy ML. BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD. BMJ Open Respir Res. 2020 Nov;7(1):e000697. doi: 10.1136/bmjresp-2020-000697.
Results Reference
derived
PubMed Identifier
25168853
Citation
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.
Results Reference
derived
Learn more about this trial
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)
We'll reach out to this number within 24 hrs