Chronic Obstructive Pulmonary DiseaseNCT02434198
Falling in Patients With COPD Referred to Pulmonary Rehabilitation: Incidence, Risk Factors and Prediction Tools
An observational study of Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Thierry Troosters, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University hospitals Leuven
Leuven, Vlaams Brabant, 3000
Thierry Troosters, PhD
Wim Janssens, MD, PhD
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- pulmonary rehabilitation, balance assessment, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of falling
Measured: 6 months
Secondary outcomes (1)
association between falling status and the score in balance tests
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Thierry Troosters, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434198
- Sponsor's protocol ID
- S57678
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falling in Patients With COPD Referred to Pulmonary Rehabilitation: Incidence, Risk Factors and Prediction Tools
- ClinicalTrials.gov ID
- NCT02434198
- Acronym / sponsor ID
- S57678
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- pulmonary rehabilitation, balance assessment, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of falling
Time frame: 6 months
1 secondary outcome
association between falling status and the score in balance tests
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Troosters, PhD contact
Thierry Troosters, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Troosters, PhD (thierry.troosters@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of falling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.