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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Tai chi; Behavioral: Mind-body breathing; Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02130
      • VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of tai chi intervention	Willingness to participate, adherence, and safety	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline- Disease specific quality of life	Chronic Respiratory Questionnaire	baseline, 12 weeks, 24 weeks
Change from baseline- Exercise capacity	six-minute walk distance, cardiopulmonary exercise testing	baseline, 12 weeks, 24 weeks
Change from baseline- Dyspnea	UCSD Shortness of Breath Questionnaire	baseline, 12 weeks, 24 weeks
Change from baseline- Psychosocial well-being	CES-D, Perceive Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Percieved Social Support	baseline, 12 weeks, 24 weeks
Change from baseline- Pulmonary function	Spirometry and lung volumes	baseline, 12 weeks, 24 weeks
Change from baseline- Physical strength and flexibility	Chair Sit and Reach, Chair Stand	baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Gloria Yeh, MD, MPH, BIDMC, Harvard Medical School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: COPD; emphysema; chronic bronchitis; pulmonary
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2010P000412; R01AT005436 (U.S. NIH Grant/Contract)