NCT00948623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

July 28, 2009

Last Update Submit

July 29, 2009

Conditions

Keywords

COPDphysical activitypulmonary rehabilitationcounseling

Outcome Measures

Primary Outcomes (1)

  • Walking time in daily life and the amount of time spent in moderate intense activities

Study Arms (2)

1

EXPERIMENTAL
Behavioral: physical activity counseling program

2

SHAM COMPARATOR
Behavioral: sham counseling program

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences, University Hospitals KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (2)

  • 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.

  • Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Thierry Troosters, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations