Clinical trial NCT01551953: BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)
Official title: BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic bronchitis
emphysema
pulmonary
COPD
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-03-13
Enrollment: 124
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of tai chi intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline- Disease specific quality of life
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline- Exercise capacity
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline- Dyspnea
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline- Psychosocial well-being
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline- Pulmonary function
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline- Physical strength and flexibility
timeFrame: baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Healthcare System
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: BIDMC, Harvard Medical School
name: Gloria Yeh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.