NCT04341753: FORMES

Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures in Patients With COPD

Completed NA Last updated 16 September 2021

What this trial tests

NA trial testing pulmonary rehabilitation in Chronic Obstructive Pulmonary Disease in 57 participants. Completed in 9 September 2021.

Timeline

14 September 2020

Primary endpoint
9 September 2021

9 September 2021

Quick facts

Lead sponsor	University Hospital, Brest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	57
Start date	14 September 2020
Primary completion	9 September 2021
Estimated completion	9 September 2021
Sites	1 location across France

Drugs / interventions tested

• pulmonary rehabilitation

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

According to the recommendations of French and international learned societies, respiratory rehabilitation is part of the care of patients with Chronic Obstructive Pulmonary Disease (COPD). Indeed, scientific work carried out for more than 10 years on the respiratory rehabilitation of patients suffering from COPD shows that respiratory rehabilitation allows a reduction of the handicap caused by the disease and an improvement in the quality of life of the patients.

A respiratory rehabilitation program (PRR) includes: individual exercise re-training, therapeutic education, respiratory physiotherapy, help with smoking cessation and nutritional and psychosocial care. Exercise retraining includes training the muscles of the lower limbs in endurance and strength combined with training the muscles of the upper limbs. Strengthening the upper limbs helps reduce dyspnea in patients with COPD. In order to determine a precise muscle building protocol, it is necessary to assess at the start of the program the maximum voluntary strength (FMV) of the different muscle groups of the upper limbs. Measuring FMV quantifies a possible frequent strength deficit in patients with COPD and the effects of the strengthening program. Currently, tests to assess FMV using isokinetic dynamometers are used as a benchmark. However, this material is little used in current practice. Portable dynamometers are used to perform simple tests and to obtain muscle strength measurements. However, the reliability of the maximum voluntary force measurements of the different muscle groups of the upper limb has not been evaluated. Studies seem necessary to determine the reproducibility of the measurement in intra and inter-examiner (Schrama 2014) and to assess its sensitivity to change during a respiratory rehabilitation program. The objectives of this study are to study the reproducibility, validity and sensitivity to change of the measurement of FMV using a portable dynamometer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reliability and Validity of Upper Limb Muscle Strength Measurements by Handheld Dynamometer in Patients With Chronic Obstructive Pulmonary Disease.
   Péran L, Berriet AC, Le Ber C, Consigny M, et al · · 2025 · PMID 40991671 · DOI 10.1002/pri.70111