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

Chronic Obstructive Pulmonary Disease Clinical Trial

— FORMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341753
• Other study ID #: 29BRC19.0237
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: September 9, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• pulmonary rehabilitation
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.

Locations

Country	Name	City	State
France	Centre Hospitalier des pays de Morlaix	Morlaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Epub 2016 Nov 29. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	isometric voluntary muscle strength measure, with the one repetition of maximal resistance (1-MR) test (with dumbbells)	the strength of the deltoid, biceps, triceps muscles is measured with 1-MR test	up to 4 weeks
Secondary	isometric voluntary muscle strength measure, with hand held dynamometer	the strength of the deltoid, biceps, triceps muscles is measured with handheld dynamometer, a te the beginning and and the end of the pulmonary rehabilitation program	4 weeks
Secondary	the 6-minute walk test	The improvement in exercise capacity is measured in the 6-minute walk test	up to 4 weeks
Secondary	1-minute sit to stand test	The improvement in exercise capacity is measured during a 1-minute sit to stand test	up to 4 weeks
Secondary	The voluntary force of the quadriceps	the maximum voluntary force of the quadriceps is measured with a MICROFET dynamometer	up to 4 weeks
Secondary	he endurance time of quadriceps	the improvement of the endurance time of quadriceps is mesured with a MICROFET dynamometer	up to 4 weeks
Secondary	The dyspnea sensation by Modified Medical Research Council scale	The improvement in dyspnea sensation is measured with the Modified Medical Research Council scale This unidimensional scale is used to assess dyspnea in the daily life of a patient from stage 0 to stage 4.	up to 4 weeks
Secondary	The dyspnea sensation by LCADL questionnaire	he improvement in dyspnea sensation is measured with the LCADL questionnaire The purpose of this questionnaire is to help understand how the patient perceives and feels your breathing with a score from 0 to 75	up to 4 weeks
Secondary	the dyspnea sensation by dypsnea-12 scale	The improvement in dyspnea sensation is measured with the dypsnea-12 scale. This questionnaire is used to evaluate the physical and emotional aspects of dyspnea with 12 questions.	up to 4 weeks
Secondary	the dyspnea sensation by MDP questionnaire	The improvement in dyspnea sensation is measured with the MDP questionnaire This questionnaire makes it possible to measure the discomfort, the sensory qualities of the dyspnea, the intensity of the sensations, the emotional sensations.	up to 4 weeks
Secondary	Quality of life by CAT questionnaire	The improvement in quality of life is measured with CAT questionnaire. The CAT is one component in clinical decision-making, along with other considerations such as history of previous exacerbations and airflow limitation. A score is calculated from 8 questions with an answer from 0 to 5.	up to 4 weeks
Secondary	Quality of life by St Georges questionnaire	The improvement in quality of life is measured with St Georges questionnaire This questionnaire is a self-reported disease-specific, health-related quality of life questionnaire. It was originally developed to measure the impact of Chronic Obstructive Pulmonary Disease on a person's life, but has also been studied and applied to non-COPD pulmonary populations.	up to 4 weeks
Secondary	Fear of falling	The decrease in fear of falling is measured with the FES-I questionnaire. This questionnaire evaluates the fear of falling with a score from 0 to 30.	up to 4 weeks
Secondary	Anxiety and depression	The evolution of anxiety and depression is measured with HAD scale This scale is an instrument for screening for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions are related to the anxiety dimension (total A) and seven others to the depressive dimension (total D), allowing two scores to be obtained (maximum score of each score = 21).	up to 4 weeks
Secondary	Self-esteem	The changes in self-esteem are measured with ISP-6 questionnaire This questionnaire is a 6-question questionnaire on overall self-esteem giving a score of	up to 4 weeks
Secondary	Evolution of the non fat mass index	The evolution of the non fat mass index is measured with impedancemetry	up to 4 weeks