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NCT Number: NCT04341753

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier des pays de Morlaix

Morlaix, 29672, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change isometric voluntary muscle strength measure, with hand held dynamometer

    Time frame: up to 4 weeks

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

Secondary outcomes

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

    Time frame: up to 4 weeks

    the strength of the deltoid, biceps, triceps muscles is measured with 1-MR test

  2. isometric voluntary muscle strength measure, with hand held dynamometer

    Time frame: 4 weeks

    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

  3. the 6-minute walk test

    Time frame: up to 4 weeks

    The improvement in exercise capacity is measured in the 6-minute walk test

  4. 1-minute sit to stand test

    Time frame: up to 4 weeks

    The improvement in exercise capacity is measured during a 1-minute sit to stand test

  5. The voluntary force of the quadriceps

    Time frame: up to 4 weeks

    the maximum voluntary force of the quadriceps is measured with a MICROFET dynamometer

  6. he endurance time of quadriceps

    Time frame: up to 4 weeks

    the improvement of the endurance time of quadriceps is mesured with a MICROFET dynamometer

  7. The dyspnea sensation by Modified Medical Research Council scale

    Time frame: up to 4 weeks

    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.

  8. The dyspnea sensation by LCADL questionnaire

    Time frame: up to 4 weeks

    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

  9. the dyspnea sensation by dypsnea-12 scale

    Time frame: up to 4 weeks

    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.

  10. the dyspnea sensation by MDP questionnaire

    Time frame: up to 4 weeks

    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.

  11. Quality of life by CAT questionnaire

    Time frame: up to 4 weeks

    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.

  12. Quality of life by St Georges questionnaire

    Time frame: up to 4 weeks

    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.

  13. Fear of falling

    Time frame: up to 4 weeks

    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.

  14. Anxiety and depression

    Time frame: up to 4 weeks

    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).

  15. Self-esteem

    Time frame: up to 4 weeks

    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

  16. Evolution of the non fat mass index

    Time frame: up to 4 weeks

    The evolution of the non fat mass index is measured with impedancemetry

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: FORMES

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2020
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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