Mind-Body Exercise for COPD: A Pilot Study

This study has been completed.

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by:

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01007903

First received: November 3, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 3, 2009

Last Updated Date

November 3, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Study feasibility [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Quality of life
Exercise capacity

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mind-Body Exercise for COPD: A Pilot Study

Official Title ^ICMJE

Tai Chi Exercise in Patients With Chronic Obstructive Pulmonary Disease

Brief Summary

This is a pilot randomized controlled trial of feasibility and preliminary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

COPD

Intervention ^ICMJE

Behavioral: Tai Chi exercise

12-week tai chi exercise class

Study Arm (s)

No Intervention: Usual Care
Intervention: Behavioral: Tai Chi exercise
Experimental: Tai Chi
Intervention: Behavioral: Tai Chi exercise

Publications *

Yeh GY, Roberts DH, Wayne PM, Davis RB, Quilty MT, Phillips RS. Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study. Respir Care. 2010 Nov;55(11):1475-82.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

physician diagnosis of COPD
FEV1<65% of predicted and FEV1/FVC<0.70
≥45 years old

Exclusion Criteria:

COPD exacerbation requiring ER visit or hospitalization within past month
planned major pulmonary intervention in coming 3 months
severe peripheral vascular disease/claudication or other physical condition precluding walk test
inability to perform bicycle ergometry
severe cognitive dysfunction (MMSE ≤ 24)
inability to speak English
current participation in a pulmonary rehabilitation or regular practice of tai chi

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01007903

Other Study ID Numbers ^ICMJE

2007-P-000065

Has Data Monitoring Committee

Not Provided

Responsible Party

Russell Phillips, MD, Beth Israel Deaconess Medical Center

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Gloria Yeh, MD, MPH

Harvard Medical School

Information Provided By

Beth Israel Deaconess Medical Center

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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