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

NCT ID: NCT03152344

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-02
• Study Completion Date: 2017-10-27

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• Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.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

Conditions

COPD Diagnosed

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Timed Up and Go

Intervention Type: PROCEDURE

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).

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

Timed Up and Go

Intervention Type: PROCEDURE

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).

Interventions

Timed Up and Go

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Countries

France

Other Identifiers

2016-A01188-43

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-332

Identifier Type: -

Identifier Source: org_study_id