A Controlled Study of Community-based Exercise Training i... | NCT01985529

Studies
A Controlled Study of Community-based Exercise Training in Patients With Moderate COPD

NCT01985529

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Nov 15, 2013Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

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

Nov 2013

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

Dec 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 8, 2013

First Posted Date

Nov 15, 2013Estimated

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

Nov 8, 2013

Last Update Posted Date

Nov 15, 2013Estimated

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

The effectiveness of clinic-based pulmonary rehabilitation in advanced Chronic Obstructive Pulmonary Disease (COPD) is well established, but few data exist for less severe patients treated in alternative settings. The purpose of this study was to investigate whether a novel, community-based exercise program was feasible and effective for patients with moderate COPD.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	Enrollment in pulmonary rehabilitation	Other: Exercise
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other		Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endurance	Change in endurance of physical activity was measured in seconds.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Muscle Strength	Change in muscle strength was measures in pounds of weight lifted	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with moderate COPD and self-reported exercise impairment

Exclusion Criteria:

current smokers, pulmonary diseases other than COPD, use of supplemental oxygen, musculoskeletal disease that impaired exercise performance and unstable coronary artery disease or congestive heart failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Cooper, MD	University of California, Los Angeles	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Westwood, Los Angeles	California	90095	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25088030	Derived	Amin S, Abrazado M, Quinn M, Storer TW, Tseng CH, Cooper CB. A controlled study of community-based exercise training in patients with moderate COPD. BMC Pulm Med. 2014 Aug 4;14:125. doi: 10.1186/1471-2466-14-125.

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

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena