NCT02434198

Brief Summary

The primary aim of this study is to investigate the incidence of falling in a cohort of patients with chronic obstructive pulmonary disease (COPD) referred to a pulmonary rehabilitation program and to verify the risk factors. The secondary aim is to verify whether available balance assessment tools are feasible in clinical practice and which tools and values can best predict falls in people with COPD.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

April 30, 2015

Last Update Submit

May 4, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

pulmonary rehabilitationbalance assessmentChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • incidence of falling

    6 months

Secondary Outcomes (1)

  • association between falling status and the score in balance tests

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred to the outpatient pulmonary rehabilitation (PR) program in the Gasthuisberg University Hospital (Leuven, Belgium) will be screened for eligibility.

You may qualify if:

  • Patients with a primary diagnosis of COPD according to internationally accepted guidelines
  • All patients referred to the outpatient PR program of Gasthuisberg University Hospital (Leuven, Belgium).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospitals Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thierry Troosters, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Troosters, PhD

CONTACT

thierry.troosters@kuleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Last Updated

May 5, 2015

Record last verified: 2015-04

Locations

BE(1)