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

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.

Study Overview

• Status: Completed
• Conditions: COPD Diagnosed
• Intervention / Treatment: Procedure: Timed Up and Go

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• Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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).
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	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the TUG test and the BBS	to detect fall as assessed by the Elderly Falls Screening Test.	at day 1
Difference in BBS score	between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).	at day 1
Identify predictive factors of fall risk	walk distance, quadriceps force, muscle mass, balance control.	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Balance control; Oxygen; Fall; Skeletal muscle mass; Screening test
• Other Study ID Numbers: CHU-332; 2016-A01188-43 (Other Identifier: 2016-A01188-43)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No