Falling in Patients With COPD Referred to Pulmonary Rehab... | NCT02434198

Studies
Falling in Patients With COPD Referred to Pulmonary Rehabilitation: Incidence, Risk Factors and Prediction Tools

NCT02434198

Sponsor

KU Leuven

Status

Unknown status

Last Update Posted

May 5, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

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

Apr 2015

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

Jan 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

May 4, 2015

First Posted Date

May 5, 2015Estimated

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

May 4, 2015

Last Update Posted Date

May 5, 2015Estimated

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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of falling		6 months

Secondary Outcomes

Measure	Description	Time Frame
association between falling status and the score in balance tests		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

None

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thierry Troosters, PhD	Contact			thierry.troosters@kuleuven.be

Overall Officials

Name	Affiliation	Role
Thierry Troosters, PhD	KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospitals Leuven	Recruiting	Leuven	Vlaams Brabant	3000	Belgium

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