Chronic Obstructive Pulmonary DiseaseFORMESNCT04341753
Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures in Patients With COPD
A study testing pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Brest at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2020to 9 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures With Handheld Dynamometer, 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 weeks
Secondary outcomes (16)
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
Measured: up to 4 weeks
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
Measured: 4 weeks
the 6-minute walk test
The improvement in exercise capacity is measured in the 6-minute walk test
Measured: up to 4 weeks
1-minute sit to stand test
The improvement in exercise capacity is measured during a 1-minute sit to stand test
Measured: up to 4 weeks
The voluntary force of the quadriceps
the maximum voluntary force of the quadriceps is measured with a MICROFET dynamometer
Measured: up to 4 weeks
he endurance time of quadriceps
the improvement of the endurance time of quadriceps is mesured with a MICROFET dynamometer
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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.
Measured: up to 4 weeks
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).
Measured: up to 4 weeks
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
Measured: up to 4 weeks
Evolution of the non fat mass index
The evolution of the non fat mass index is measured with impedancemetry
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start14 Sep 2020
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc PERAN, Principal investigator, CH des pays de Morlaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341753
- Sponsor's protocol ID
- 29BRC19.0237
- Acronym
- FORMES
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in publication
Publications
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.
PubMed 27942118Nyberg 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.
PubMed 26208090Peran 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.
PubMed 40991671
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures With Handheld Dynamometer, in Patients With COPD
- ClinicalTrials.gov ID
- NCT04341753
- Acronym / sponsor ID
- FORMES / 29BRC19.0237
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: pulmonary rehabilitationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitationthe 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 |
Primary outcome
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
16 secondary outcomes
isometric voluntary muscle strength measure, with the one repetition of maximal resistance (1-MR) test (with dumbbells)
Time frame: up to 4 weeks
isometric voluntary muscle strength measure, with hand held dynamometer
Time frame: 4 weeks
the 6-minute walk test
Time frame: up to 4 weeks
1-minute sit to stand test
Time frame: up to 4 weeks
The voluntary force of the quadriceps
Time frame: up to 4 weeks
he endurance time of quadriceps
Time frame: up to 4 weeks
The dyspnea sensation by Modified Medical Research Council scale
Time frame: up to 4 weeks
The dyspnea sensation by LCADL questionnaire
Time frame: up to 4 weeks
the dyspnea sensation by dypsnea-12 scale
Time frame: up to 4 weeks
the dyspnea sensation by MDP questionnaire
Time frame: up to 4 weeks
Quality of life by CAT questionnaire
Time frame: up to 4 weeks
Quality of life by St Georges questionnaire
Time frame: up to 4 weeks
Fear of falling
Time frame: up to 4 weeks
Anxiety and depression
Time frame: up to 4 weeks
Self-esteem
Time frame: up to 4 weeks
Evolution of the non fat mass index
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 27942118Awatani 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.
- Background: PubMed 26208090Nyberg 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.
- Derived from this study: PubMed 40991671Peran 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc PERAN principal investigator
CH des pays de Morlaix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change isometric voluntary muscle strength measure, with hand held dynamometer (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341753, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.