COPD DiagnosedEquil-BPCONCT03152344
Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk.
An observational study of COPD Diagnosed, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD Diagnosed
- What is being tested?
- Timed Up and Go
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2017to 27 Oct 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
Who may be able to join
- COPD confirmed by pulmonary function tests
- Long term oxygen therapy since at least 3 months in the LOT+ subgroup
Who cannot join
- Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
- Pulmonary rehabilitation in the last 3 months
- Any neurological disease affecting balance control.
- Inability to perform a walk test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.
The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.
Read the detailed description
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires:
- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.
Tests:
- Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)
- Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
- 6 minute walk test evaluating endurance to submaximal exercise.
- Isokinetic maximal force of the quadriceps at 60°/s
- Balance control: posturography consisting in measuring variations when standing on a force platform.
- Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
- Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.
Analysis of the results:
We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.
Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).
Perspectives:
When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.
- Conditions
- COPD Diagnosed
- Being tested
- Timed Up and Go
- Keywords
- Fall, Balance control, Screening test, Oxygen, Skeletal muscle mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timed Up and GoProcedure or surgery
It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
| Study group | Role | What they receive |
|---|---|---|
| COPD patients without chronic respiratory failure | We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires Receives: Procedure: Timed Up and Go | |
| COPD patients with home oxygen therapy | We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires Receives: Procedure: Timed Up and Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Timed Up and Go test and the Berg Balance scale
Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
Measured: at day 1
Secondary outcomes (3)
Sensitivity of the TUG test and the BBS
to detect fall as assessed by the Elderly Falls Screening Test.
Measured: at day 1
Difference in BBS score
between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).
Measured: at day 1
Identify predictive factors of fall risk
walk distance, quadriceps force, muscle mass, balance control.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start2 Jan 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD DiagnosedStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152344
- Sponsor's protocol ID
- CHU-332
- Other IDs
- 2016-A01188-43
- Acronym
- Equil-BPCO
- Status last verified
- Aug 2019
- First submitted
- 11 May 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.
- ClinicalTrials.gov ID
- NCT03152344
- Acronym / sponsor ID
- Equil-BPCO / CHU-332
- Conditions
- COPD Diagnosed
- Keywords
- Fall, Balance control, Screening test, Oxygen, Skeletal muscle mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 15 May 2017 (actual)
- 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 risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.
The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.
Detailed description
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires:
- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.
Tests:
- Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)
- Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
- 6 minute walk test evaluating endurance to submaximal exercise.
- Isokinetic maximal force of the quadriceps at 60°/s
- Balance control: posturography consisting in measuring variations when standing on a force platform.
- Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
- Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.
Analysis of the results:
We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.
Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).
Perspectives:
When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients without chronic respiratory failure | – | Procedure: Timed Up and GoWe will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. The patients will be proposed to perform the following tests and to fill in questionnaires |
| COPD patients with home oxygen therapy | – | Procedure: Timed Up and GoWe will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. The patients will be proposed to perform the following tests and to fill in questionnaires |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
Key inclusion criteria (2 listed)
- COPD confirmed by pulmonary function tests
- Long term oxygen therapy since at least 3 months in the LOT+ subgroup
Key exclusion criteria (4 listed)
- Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
- Pulmonary rehabilitation in the last 3 months
- Any neurological disease affecting balance control.
- Inability to perform a walk test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timed Up and GoIt's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds). | Procedure or surgery | COPD patients with home oxygen therapy, COPD patients without chronic respiratory failure |
Primary outcome
Comparison of the Timed Up and Go test and the Berg Balance scale
Time frame: at day 1
Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
3 secondary outcomes
Sensitivity of the TUG test and the BBS
Time frame: at day 1
Difference in BBS score
Time frame: at day 1
Identify predictive factors of fall risk
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD Diagnosed, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Timed Up and Go test and the Berg Balance scale (time frame: at day 1). 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 13 Aug 2019.