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

NCT03152344 | Completed

• 2 other identifiers: CHU-3322016-A01188-43
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Diagnosed

Keywords

Fall; Balance control; Screening test; Oxygen; Skeletal muscle mass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity of the TUG test and the BBS

  at day 1

• Difference in BBS score

  at day 1

• Identify predictive factors of fall risk

  at day 1

Study Arms (2)

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

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

Interventions

Timed Up and Go 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; COPD patients without chronic respiratory failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: January 2, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

FR (1)