Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk.
- Conditions
- COPD Diagnosed
- Interventions
- Procedure: Timed Up and Go
- Registration Number
- NCT03152344
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief 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.
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* Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- COPD confirmed by pulmonary function tests
- Long term oxygen therapy since at least 3 months in the LOT+ subgroup
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COPD patients without chronic respiratory failure Timed Up and Go 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 COPD patients with home oxygen therapy Timed Up and Go 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
- Primary Outcome Measures
Name Time Method Comparison of the Timed Up and Go test and the Berg Balance scale at day 1 Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
- Secondary Outcome Measures
Name Time Method Identify predictive factors of fall risk at day 1 walk distance, quadriceps force, muscle mass, balance control.
Sensitivity of the TUG test and the BBS at day 1 to detect fall as assessed by the Elderly Falls Screening Test.
Difference in BBS score at day 1 between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, Auvergne, France