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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier des pays de Morlaix

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
the 6-minute walk test
The improvement in exercise capacity is measured in the 6-minute walk test
1-minute sit to stand test
The improvement in exercise capacity is measured during a 1-minute sit to stand test
The voluntary force of the quadriceps
the maximum voluntary force of the quadriceps is measured with a MICROFET dynamometer
he endurance time of quadriceps
the improvement of the endurance time of quadriceps is mesured with a MICROFET dynamometer
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.
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
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.
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.
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.
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.
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.
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).
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
Evolution of the non fat mass index
The evolution of the non fat mass index is measured with impedancemetry

Full Information

First Posted
April 6, 2020
Last Updated
September 15, 2021
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04341753
Brief Title
Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures in Patients With COPD
Acronym
FORMES
Official Title
Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures With Handheld Dynamometer, in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Change isometric voluntary muscle strength measure, with hand held dynamometer
Description
the strength of the deltoid, biceps, triceps muscles is measured with handheld dynamometer, 3 times
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
isometric voluntary muscle strength measure, with the one repetition of maximal resistance (1-MR) test (with dumbbells)
Description
the strength of the deltoid, biceps, triceps muscles is measured with 1-MR test
Time Frame
up to 4 weeks
Title
isometric voluntary muscle strength measure, with hand held dynamometer
Description
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
Time Frame
4 weeks
Title
the 6-minute walk test
Description
The improvement in exercise capacity is measured in the 6-minute walk test
Time Frame
up to 4 weeks
Title
1-minute sit to stand test
Description
The improvement in exercise capacity is measured during a 1-minute sit to stand test
Time Frame
up to 4 weeks
Title
The voluntary force of the quadriceps
Description
the maximum voluntary force of the quadriceps is measured with a MICROFET dynamometer
Time Frame
up to 4 weeks
Title
he endurance time of quadriceps
Description
the improvement of the endurance time of quadriceps is mesured with a MICROFET dynamometer
Time Frame
up to 4 weeks
Title
The dyspnea sensation by Modified Medical Research Council scale
Description
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.
Time Frame
up to 4 weeks
Title
The dyspnea sensation by LCADL questionnaire
Description
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
Time Frame
up to 4 weeks
Title
the dyspnea sensation by dypsnea-12 scale
Description
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.
Time Frame
up to 4 weeks
Title
the dyspnea sensation by MDP questionnaire
Description
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.
Time Frame
up to 4 weeks
Title
Quality of life by CAT questionnaire
Description
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.
Time Frame
up to 4 weeks
Title
Quality of life by St Georges questionnaire
Description
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.
Time Frame
up to 4 weeks
Title
Fear of falling
Description
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.
Time Frame
up to 4 weeks
Title
Anxiety and depression
Description
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).
Time Frame
up to 4 weeks
Title
Self-esteem
Description
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
Time Frame
up to 4 weeks
Title
Evolution of the non fat mass index
Description
The evolution of the non fat mass index is measured with impedancemetry
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc PERAN
Organizational Affiliation
CH des pays de Morlaix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier des pays de Morlaix
City
Morlaix
ZIP/Postal Code
29672
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in publication
IPD Sharing Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion
IPD Sharing 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
Citations:
PubMed Identifier
27942118
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.
Results Reference
background
PubMed Identifier
26208090
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.
Results Reference
background

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

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