COPDREHABSUPNCT03611036
Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
A study testing Strength training and Endurance training in people with COPD, run by University Hospital, Brest at 2 sites in France.
Trial summary
Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Strength training and Endurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Nov 2018to 6 Feb 2023
- 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 stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program (4 weeks)
- Patient aged 18 or over
- Patient able to consent and having signed a consent form
Who cannot join
- Patient with pain, osteoarthritis or shoulder surgery
- Patient with a history of Pneumonectomy, lobectomy less than 6 months old
- Refusal of participation
- Patient with an inability to complete a pulmonary rehabilitation program in totality
- Pregnant or breast-feeding women
- Patient under tutorship or curatorship
Trial locations and contacts
2 sites in 1 country.
About this study
Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.
- Conditions
- COPD
- Being tested
- Strength training, Endurance training
- 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.
Strength trainingOther
Upper limbs Strength training; done with dumbbells whose weight corresponds to 60-80% of the maximal voluntary force in abduction measured initially, during 4 weeks
Endurance trainingOther
Upper limbs Endurance training of the ; done with dumbbells whose weight corresponds to 30% of the maximum voluntary force in abduction measured initially, during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Strength | Experimental | Patients will follow the pulmonary rehabilitation program associated with upper limbs strength training for a duration of 4 weeks Receives: Other: Strength training |
| Endurance | Active comparator | Patients will follow the pulmonary rehabilitation program associated with upper limbs endurance training for a duration of 4 weeks Receives: Other: Endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of upper limbs strength training versus the effect of upper limb endurance training on dyspnea in patients with COPD during a pulmonary rehabilitation program.
Measurement of dyspnea using the London Chest Daily Activity Living (LCADL) questionnaire.
This 15-item, self-administered questionnaire allows an evaluation of dyspnea in patients with COPD during daily activities divided into four components: self-care, domestic, physical, and leisure. Patients could score from 0: "I would not do anyway" to 5: "I need someone else to do this". LCADL score is calculated by aggregating the points assigned to each question, with a higher score representing maximal disability.
Measured: Change from inclusion at 4 week
Secondary outcomes (6)
Compare dyspnea in daily life between the 2 groups
Measurement of dyspnea using mMRC scale. mMRC dyspnea scale is the first self-administered scale which assesses the impact of dyspnea on ADL. It consists of five grades increasing in severity of chronic respiratory disease from 0 : "I only get breathless with strenuous exercise" to 4 : "I am too breathless to leave the house or I am breathless when dressing or undressing."
Measured: At inclusion and week 4
Compare dyspnea in daily life between the 2 groups
Measurement of dyspnea using Dyspnea-12 questionnaire. This 12-item self-administered questionnaire measures dyspnea severity in both its physical and affective components, independently from activity limitation. Patients score ranges from "none" (corresponding to score 0) to "severe" (score 3). Dyspnea-12 score is calculated by aggregating the points assigned to each question; the higher the score, the greater the severity.
Measured: At inclusion and week 4
Measuring upper limb endurance
with the 6-minute Peg Board and Ring Test (6PBRT)
Measured: At inclusion and week 4
Compare dyspnea at the end of a functional test using the upper limbs
Measurement of dyspnea with Borg scale at the end of 6PBRT. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort.
Measured: At inclusion and week 4
Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs
Measurement of upper limbs muscle fatigue with Borg scale at the end of 6PBRT. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: "very light, difficult, painful ..." effort.
Measured: At inclusion and week 4
Compare the evolution of upper limb strength between the 2 groups.
Measurement of the strength of deltoids, biceps and brachial triceps, with hand held dynamometer
Measured: At inclusion and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start21 Nov 2018
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, prospective, randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc BEAUMONT, PhD, Principal investigator, CH des pays de MorlaixFrancis COUTURAUD, MD, PhD, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611036
- Sponsor's protocol ID
- REHABSUP (29BRC18.0070)
- Acronym
- REHABSUP
- Status last verified
- Jan 2025
- First submitted
- 16 Jul 2018
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beaumont M, Peran L, Berriet AC, Ber CL, Courtois-Communier E, Couturaud F. Effect of different forms of upper limb muscle training on dyspnea in chronic obstructive pulmonary disease: a randomised controlled trial. Ann Phys Rehabil Med. 2025 Oct;68(7):102021. doi: 10.1016/j.rehab.2025.102021. Epub 2025 Sep 17.
PubMed 40966966Beaumont M, Peran L, Berriet AC, Le Ber C, Le Mevel P, Courtois-Communier E, Couturaud F. Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22131. doi: 10.1097/MD.0000000000022131.
PubMed 32957334
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD
- ClinicalTrials.gov ID
- NCT03611036
- Acronym / sponsor ID
- REHABSUP / REHABSUP (29BRC18.0070)
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 2 Aug 2018 (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.
Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, prospective, randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Strength | Experimental | Other: Strength trainingPatients will follow the pulmonary rehabilitation program associated with upper limbs strength training for a duration of 4 weeks |
| Endurance | Active comparator | Other: Endurance trainingPatients will follow the pulmonary rehabilitation program associated with upper limbs endurance training for a duration of 4 weeks |
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 stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program (4 weeks)
- Patient aged 18 or over
- Patient able to consent and having signed a consent form
Key exclusion criteria (6 listed)
- Patient with pain, osteoarthritis or shoulder surgery
- Patient with a history of Pneumonectomy, lobectomy less than 6 months old
- Refusal of participation
- Patient with an inability to complete a pulmonary rehabilitation program in totality
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Strength trainingUpper limbs Strength training; done with dumbbells whose weight corresponds to 60-80% of the maximal voluntary force in abduction measured initially, during 4 weeks | Other | Strength |
| Endurance trainingUpper limbs Endurance training of the ; done with dumbbells whose weight corresponds to 30% of the maximum voluntary force in abduction measured initially, during 4 weeks | Other | Endurance |
Primary outcome
Compare the effect of upper limbs strength training versus the effect of upper limb endurance training on dyspnea in patients with COPD during a pulmonary rehabilitation program.
Time frame: Change from inclusion at 4 week
Measurement of dyspnea using the London Chest Daily Activity Living (LCADL) questionnaire. This 15-item, self-administered questionnaire allows an evaluation of dyspnea in patients with COPD during daily activities divided into four components: self-care, domestic, physical, and leisure. Patients could score from 0: "I would not do anyway" to 5: "I need someone else to do this". LCADL score is calculated by aggregating the points assigned to each question, with a higher score representing maximal disability.
6 secondary outcomes
Compare dyspnea in daily life between the 2 groups
Time frame: At inclusion and week 4
Compare dyspnea in daily life between the 2 groups
Time frame: At inclusion and week 4
Measuring upper limb endurance
Time frame: At inclusion and week 4
Compare dyspnea at the end of a functional test using the upper limbs
Time frame: At inclusion and week 4
Compare upper limbs muscle fatigue at the end of a functional test using the upper limbs
Time frame: At inclusion and week 4
Compare the evolution of upper limb strength between the 2 groups.
Time frame: At inclusion and week 4
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 24 Jan 2025.
- Derived from this study: PubMed 40966966Beaumont M, Peran L, Berriet AC, Ber CL, Courtois-Communier E, Couturaud F. Effect of different forms of upper limb muscle training on dyspnea in chronic obstructive pulmonary disease: a randomised controlled trial. Ann Phys Rehabil Med. 2025 Oct;68(7):102021. doi: 10.1016/j.rehab.2025.102021. Epub 2025 Sep 17.
- Derived from this study: PubMed 32957334Beaumont M, Peran L, Berriet AC, Le Ber C, Le Mevel P, Courtois-Communier E, Couturaud F. Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol. Medicine (Baltimore). 2020 Sep 18;99(38):e22131. doi: 10.1097/MD.0000000000022131.
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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.
Marc BEAUMONT, PhD principal investigator
CH des pays de Morlaix
Francis COUTURAUD, MD, PhD study director
CHRU de Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and Endurance training in people with COPD, run by University Hospital, Brest at 2 sites 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 6 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Compare the effect of upper limbs strength training versus the effect of upper limb endurance training on dyspnea in patients with COPD during a pulmonary rehabilitation program. (time frame: Change from inclusion at 4 week). 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 NCT03611036, which also lists 2 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 24 Jan 2025.