Physical Activity Counseling During Pulmonary Rehabilitation | NCT00948623

Studies
Physical Activity Counseling During Pulmonary Rehabilitation

NCT00948623

Sponsor

KU Leuven

Status

Unknown status

Last Update Posted

Jul 30, 2009Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

physical activity counseling program
sham counseling program

Countries

Belgium

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

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 29, 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

Jul 29, 2009

Last Update Posted Date

Jul 30, 2009Estimated

Name	Class
Fund for Scientific Research, Flanders, Belgium	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

This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life during and after an outpatient pulmonary rehabilitation program.

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Behavioral: physical activity counseling program
2	Sham Comparator		Behavioral: sham counseling program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical activity counseling program	Behavioral		1
sham counseling program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Walking time in daily life and the amount of time spent in moderate intense activities

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spirometry-proven COPD
Referred for 6-month outpatient pulmonary rehabilitation program

Exclusion Criteria:

Orthopedic problems impairing daily activities
Progressive neurological or neuromuscular disorders
Psychiatric or cognitive disorders
Patients on the waiting list for lung transplantation

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

Name	Role	Phone	Extension	Email
Thierry Troosters, PT, PhD	Contact	+3216347107		chris.burtin@med.kuleuven.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rehabilitation Sciences, University Hospitals KULeuven	Recruiting	Leuven	Vlaams-Brabant	3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26697853	Derived	Burtin C, Langer D, van Remoortel H, Demeyer H, Gosselink R, Decramer M, Dobbels F, Janssens W, Troosters T. Physical Activity Counselling during Pulmonary Rehabilitation in Patients with COPD: A Randomised Controlled Trial. PLoS One. 2015 Dec 23;10(12):e0144989. doi: 10.1371/journal.pone.0144989. eCollection 2015.
24603844	Derived

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D009043	Motor Activity

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