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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— BEAM COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551953
• Other study ID #: 2010P000412
• Secondary ID: R01AT005436
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2012
• Last updated: February 23, 2017
• Start date: February 2011
• Est. completion date: April 2016

Study information

• Verified date: February 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Tai chi
12 week tai chi class
• Mind-body breathing
12 week breathing class
• Education
12 week education class

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	VA Healthcare System	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of tai chi intervention	Willingness to participate, adherence, and safety	12 weeks
Secondary	Change from baseline- Disease specific quality of life	Chronic Respiratory Questionnaire	baseline, 12 weeks, 24 weeks
Secondary	Change from baseline- Exercise capacity	six-minute walk distance, cardiopulmonary exercise testing	baseline, 12 weeks, 24 weeks
Secondary	Change from baseline- Dyspnea	UCSD Shortness of Breath Questionnaire	baseline, 12 weeks, 24 weeks
Secondary	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
Secondary	Change from baseline- Pulmonary function	Spirometry and lung volumes	baseline, 12 weeks, 24 weeks
Secondary	Change from baseline- Physical strength and flexibility	Chair Sit and Reach, Chair Stand	baseline, 12 weeks, 24 weeks