Clinical Trials Directory

Trials / Completed

CompletedNCT03152344

Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk.

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.

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
University Hospital, Clermont-Ferrand · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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 * Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.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.

Conditions

Interventions

TypeNameDescription
PROCEDURETimed 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).

Timeline

Start date
2017-01-02
Primary completion
2017-10-27
Completion
2017-10-27
First posted
2017-05-15
Last updated
2019-08-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03152344. Inclusion in this directory is not an endorsement.