Rehabilitation in Subjects With Moderate Chronic Obstruct... | NCT01320930

Studies
Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)

NCT01320930

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Mar 23, 2011Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Pulmonary rehabilitation
conventional care

Countries

Not provided

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

Jan 2011

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

Jan 2007

Primary Completion Date

Jan 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

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

Mar 22, 2011

Last Update Posted Date

Mar 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Bispebjerg HospitalOTHER

Collaborators

Name	Class
Ministry of the Interior and Health, Denmark	OTHER_GOV
Danish Lung Association	OTHER
Sygekassernes Helsefond	OTHER

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 study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary rehabilitation	Active Comparator	A standardized 7 week rehabilitation program, including physical training and education.	Behavioral: Pulmonary rehabilitation
Control	Placebo Comparator	Conventional care	Behavioral: conventional care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehabilitation	Behavioral		Pulmonary rehabilitation
conventional care

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of moderate COPD.
Motivation for Pulmonary rehabilitation.

Exclusion Criteria:

Comorbidity contraindicating rehabilitation.
Participation in pulmonary rehabilitation within the last year.
Cognitive disorders limiting the ability to participate in physical training and education sessions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

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