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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Behavioral: Mind-body breathing; Behavioral: Tai chi; Behavioral: Education

• Registration Number: NCT01551953
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mind-body breathing	Mind-body breathing	-
tai chi exercise	Tai chi	-
education	Education	-

Primary Outcome Measures

Name	Time	Method
Feasibility of tai chi intervention	12 weeks	Willingness to participate, adherence, and safety

Secondary Outcome Measures

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

Trial Locations

Locations (2)

VA Healthcare System; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States