Tai Chi Exercise in Patients With COPD | NCT01027338

Studies
Tai Chi Exercise in Patients With COPD

NCT01027338

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Dec 7, 2009Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

COPD

Interventions

Tai chi exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 4, 2009

First Submission Date that Met QC Criteria

Dec 4, 2009

First Posted Date

Dec 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Tai Chi Exercise	Experimental		Other: Tai chi exercise
Usual Care	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Tai chi exercise	Other		Tai Chi Exercise

Measure	Description	Time Frame
study feasibility

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

physician diagnosis of COPD
FEV1<65% of predicted and FEV1/FVC<70% of predicted
≥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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gloria Y Yeh, MD, MPH	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000088543	Aquatic Therapy

Ancestor Terms

ID	Term
D006875	Hydrotherapy
D026741	Physical Therapy Modalities
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided