BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD) (BEAM COPD)
This study is ongoing, but not recruiting participants.
Sponsor:
Beth Israel Deaconess Medical Center
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: January 15, 2016
Last verified: January 2016
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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:
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: | May 2016 |
| Estimated Primary Completion Date: | May 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) |
| 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
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: | 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: | January 15, 2016 |
| 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 September 23, 2016