Clinical trial NCT04341753: Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures in Patients With COPD
Official title: Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures With Handheld Dynamometer, in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change isometric voluntary muscle strength measure, with hand held dynamometer
timeFrame: up to 4 weeks
Secondary outcomes:
measure: isometric voluntary muscle strength measure, with the one repetition of maximal resistance (1-MR) test (with dumbbells)
timeFrame: up to 4 weeks
measure: isometric voluntary muscle strength measure, with hand held dynamometer
timeFrame: 4 weeks
measure: the 6-minute walk test
timeFrame: up to 4 weeks
measure: 1-minute sit to stand test
timeFrame: up to 4 weeks
measure: The voluntary force of the quadriceps
timeFrame: up to 4 weeks
measure: he endurance time of quadriceps
timeFrame: up to 4 weeks
measure: The dyspnea sensation by Modified Medical Research Council scale
timeFrame: up to 4 weeks
measure: The dyspnea sensation by LCADL questionnaire
timeFrame: up to 4 weeks
measure: the dyspnea sensation by dypsnea-12 scale
timeFrame: up to 4 weeks
measure: the dyspnea sensation by MDP questionnaire
timeFrame: up to 4 weeks
measure: Quality of life by CAT questionnaire
timeFrame: up to 4 weeks
measure: Quality of life by St Georges questionnaire
timeFrame: up to 4 weeks
measure: Fear of falling
timeFrame: up to 4 weeks
measure: Anxiety and depression
timeFrame: up to 4 weeks
measure: Self-esteem
timeFrame: up to 4 weeks
measure: Evolution of the non fat mass index
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Morlaix
country: France
facility: Centre Hospitalier des pays de Morlaix
Study officials:
affiliation: CH des pays de Morlaix
name: Loïc PERAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.