SarcopeniaMUDYSANCT06870890
Impact of Sarcopenia on Dyspnea in Patients With Asthma
A study testing muscle evaluation, Dosage and Cardiopulmonary exercise test in people with Sarcopenia and Asthma, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Dyspnea in asthma, is mainly due to airway obstruction but can be caused by several alternative diagnoses. The impact of sarcopenia on dyspnea in patients with asthma is unknown. Sarcopenic asthma had a reduced physical activity and is associated with airway obstruction compared to non-sarcopenic asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Asthma, Dyspnea
- What is being tested?
- muscle evaluation, Dosage and Cardiopulmonary exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Patient affiliated to a social security scheme.
- Patient capable of giving free, informed, written and signed consent.
- Asthmatic patients with a diagnosis made by a pulmonologist on GINA level 4 or 5 treatment
- ACT asthma control score < 20
- Patient judged by the investigator to be able to to perform a maximal exercise test.
Who cannot join
- Patient under guardianship/trusteeship/supervision of justice
- Pregnant or breast-feeding women
- Unstable heart disease
- Patients who have been smoking or have stopped smoking for less than 5 years,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Camille ROLLAND-DEBORD
About this study
Dyspnea in asthma, is mainly due to airway obstruction but can be caused by several alternative diagnoses.
The impact of sarcopenia on dyspnea in patients with asthma is unknown. Sarcopenic asthma had a reduced physical activity and is associated with airway obstruction compared to non-sarcopenic asthma. In patients with obstructive pulmonary disease, sarcopenia is associated with shallow breathing and diverse sensory and affective components of exertional dyspnea .
Read more
The morbidity of sarcopenia is also increased by systemic inflammation and the production of inflammatory cytokines as found in inflammatory airway obstruction.
The investigators will investigate the prevalence and impact of sarcopenia in asthmatics patients. This will enable to better manage sarcopenia in asthmatic patients, understand its origins and personalize treatment.
- Conditions
- Sarcopenia, Asthma, Dyspnea, Dyspnea; Asthmatic, Cytokines, Adipokines
- Being tested
- muscle evaluation, Dosage, Cardiopulmonary exercise test, Questionnaire and Physical Exam
- Keywords
- Asthma, Sarcopenia, Dyspnea
- Medical subject headings
- Sarcopenia, Asthma, Dyspnea, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle evaluationDiagnostic test
The investigators will evaluate the muscle mass and muscle strenght for all patients included
DosageBiological
Also called Others dosages at rest only, Dosage of biomarkers at rest and after exercise
Evaluation of the cinetic of biomarkers during exercise
Cardiopulmonary exercise testDiagnostic test
CPET
Questionnaire and Physical ExamCombination product
Evaluating dyspnea, anxiety, sleep, physical activity, quality of life
| Study group | Role | What they receive |
|---|---|---|
| All the patient included in the study | Experimental | Not described Receives: Diagnostic Test: muscle evaluation; Biological: Dosage; Diagnostic Test: Cardiopulmonary exercise test; Combination Product: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the intensity of dyspnea during exercise mesured with Borg scale (0-10) according to the presence of sarcopenia
Recording of Borg's dyspnea score during exercise on a scale of 0 (no dyspnea) to 10 (major dyspnea)
Measured: From baseline (at rest) to the end of the exercise
Secondary outcomes (4)
Variation in exercise-induced release of biomarkers according to the presence of sarcopenia
Variation of cytokine as IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) ; adipokines ; myokines
Measured: at rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Difference in muscle mass (kg) on impedancemetry according to the presence of sarcopenia
Measured: Baseline
Difference on maximum aerobic capacity (VO2 max in L/mn) , according to the presence of sarcopenia
Difference on physical activity
Measured: immediately after the exercise test
Difference in fat mass (kg) on impedancemetry according to the presence of sarcopenia
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille ROLLAND-DEBORD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870890
- Sponsor's protocol ID
- AOI 2023 ROLLAND-DEBORD
- Acronym
- MUDYSA
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sarcopenia on Dyspnea in Patients With Asthma
- ClinicalTrials.gov ID
- NCT06870890
- Acronym / sponsor ID
- MUDYSA / AOI 2023 ROLLAND-DEBORD
- Conditions
- Sarcopenia, Asthma, Dyspnea, Dyspnea; Asthmatic, Cytokines, Adipokines
- Keywords
- Asthma, Sarcopenia, Dyspnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
Dyspnea in asthma, is mainly due to airway obstruction but can be caused by several alternative diagnoses.
The impact of sarcopenia on dyspnea in patients with asthma is unknown. Sarcopenic asthma had a reduced physical activity and is associated with airway obstruction compared to non-sarcopenic asthma. In patients with obstructive pulmonary disease, sarcopenia is associated with shallow breathing and diverse sensory and affective components of exertional dyspnea .
The morbidity of sarcopenia is also increased by systemic inflammation and the production of inflammatory cytokines as found in inflammatory airway obstruction.
The investigators will investigate the prevalence and impact of sarcopenia in asthmatics patients. This will enable to better manage sarcopenia in asthmatic patients, understand its origins and personalize treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All the patient included in the study | Experimental | Diagnostic Test: muscle evaluation, Biological: Dosage, Diagnostic Test: Cardiopulmonary exercise test, Combination Product: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patient affiliated to a social security scheme.
- Patient capable of giving free, informed, written and signed consent.
- Asthmatic patients with a diagnosis made by a pulmonologist on GINA level 4 or 5 treatment
- ACT asthma control score < 20
Key exclusion criteria (4 listed)
- Patient under guardianship/trusteeship/supervision of justice
- Pregnant or breast-feeding women
- Unstable heart disease
- Patients who have been smoking or have stopped smoking for less than 5 years,
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 |
|---|---|---|
| muscle evaluationThe investigators will evaluate the muscle mass and muscle strenght for all patients included | Diagnostic test | All the patient included in the study |
| DosageAlso: Others dosages at rest only, Dosage of biomarkers at rest and after exerciseEvaluation of the cinetic of biomarkers during exercise | Biological | All the patient included in the study |
| Cardiopulmonary exercise testCPET | Diagnostic test | All the patient included in the study |
| Questionnaire and Physical ExamEvaluating dyspnea, anxiety, sleep, physical activity, quality of life | Combination product | All the patient included in the study |
Primary outcome
Variation in the intensity of dyspnea during exercise mesured with Borg scale (0-10) according to the presence of sarcopenia
Time frame: From baseline (at rest) to the end of the exercise
Recording of Borg's dyspnea score during exercise on a scale of 0 (no dyspnea) to 10 (major dyspnea)
4 secondary outcomes
Variation in exercise-induced release of biomarkers according to the presence of sarcopenia
Time frame: at rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Difference in muscle mass (kg) on impedancemetry according to the presence of sarcopenia
Time frame: Baseline
Difference on maximum aerobic capacity (VO2 max in L/mn) , according to the presence of sarcopenia
Time frame: immediately after the exercise test
Difference in fat mass (kg) on impedancemetry according to the presence of sarcopenia
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Camille ROLLAND-DEBORD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle evaluation, Dosage and Cardiopulmonary exercise test in people with Sarcopenia and Asthma, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in the intensity of dyspnea during exercise mesured with Borg scale (0-10) according to the presence of sarcopenia (time frame: From baseline (at rest) to the end of the exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.