Clinical trial NCT03152344: Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Diagnosed
Keywords: Fall
Balance control
Screening test
Oxygen
Skeletal muscle mass
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2017-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion Criteria:

* COPD confirmed by pulmonary function tests
* Long term oxygen therapy since at least 3 months in the LOT+ subgroup

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of the Timed Up and Go test and the Berg Balance scale
timeFrame: at day 1
Secondary outcomes:
measure: Sensitivity of the TUG test and the BBS
timeFrame: at day 1
measure: Difference in BBS score
timeFrame: at day 1
measure: Identify predictive factors of fall risk
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
References: