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

NCT04341753 | Completed DMC

• 1 other identifier: 29BRC19.0237
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change isometric voluntary muscle strength measure, with hand held dynamometer

  the strength of the deltoid, biceps, triceps muscles is measured with handheld dynamometer, 3 times

  up to 4 weeks

Secondary Outcomes (16)

• isometric voluntary muscle strength measure, with the one repetition of maximal resistance (1-MR) test (with dumbbells)

  up to 4 weeks

• isometric voluntary muscle strength measure, with hand held dynamometer

  4 weeks

• the 6-minute walk test

  up to 4 weeks

• 1-minute sit to stand test

  up to 4 weeks

• The voluntary force of the quadriceps

  up to 4 weeks

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL

In addition to the usual evaluation, other tests will be carried out in addition and specifically for this study: * the strength' measure of the deltoids, triceps and brachial biceps will be carried out by another technique: the 1-RM technique (with dumbbells); * 2 other times, the strength' measure of the deltoids, triceps and brachial biceps will be carried out by handheld dynaometry.

Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitation OTHER

the strength' measure of the deltoids, triceps and brachial biceps will be carried out by another technique: the 1-RM technique (with dumbbells); \- 2 other times, the strength' measure of the deltoids, triceps and brachial biceps will be carried out by handheld dynaometry.

Pulmonary rehabilitation

Eligibility Criteria

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

You may qualify if:

• Patient with COPD stages 2 to 4 (A to D) admitted to the pulmonary rehabilitation unit of Centre Hospitalier des Pays de Morlaix (4 weeks)
• Patient able to consent and having signed a consent form
• Patient 18 years of age or older

You may not qualify if:

• Patient with pain, arthritis, prosthetics, shoulder or elbow surgery.
• Patient with a history of pneumonectomy, lobectomy less than 6 months old
• Refusal to participate
• Patient with an inability to follow a full respiratory rehabilitation program
• Patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Centre Hospitalier des pays de Morlaix

Morlaix, 29672, France

Location

Related Publications (3)

• Awatani T, Morikita I, Shinohara J, Mori S, Nariai M, Tatsumi Y, Nagata A, Koshiba H. Intra- and inter-rater reliability of isometric shoulder extensor and internal rotator strength measurements performed using a hand-held dynamometer. J Phys Ther Sci. 2016 Nov;28(11):3054-3059. doi: 10.1589/jpts.28.3054. Epub 2016 Nov 29.

  PMID: 27942118 BACKGROUND

• Nyberg A, Saey D, Maltais F. Why and How Limb Muscle Mass and Function Should Be Measured in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2015 Sep;12(9):1269-77. doi: 10.1513/AnnalsATS.201505-278PS.

  PMID: 26208090 BACKGROUND

• Peran L, Berriet AC, Le Ber C, Consigny M, Beaumont M. Reliability and Validity of Upper Limb Muscle Strength Measurements by Handheld Dynamometer in Patients With Chronic Obstructive Pulmonary Disease. Physiother Res Int. 2025 Oct;30(4):e70111. doi: 10.1002/pri.70111.

  PMID: 40991671 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loïc PERAN

  CH des pays de Morlaix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 10, 2020
• Study Start: September 14, 2020
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH will be required to sign and complete a data access agreement

Locations

FR (1)