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NCT Number: NCT06870890

Impact of Sarcopenia on Dyspnea in Patients With Asthma

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.

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Key information

Conditions

Sarcopenia Adipokines Asthma Atrophy Bronchial Diseases Cytokines Dyspnea Dyspnea; Asthmatic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Muscle Disorder Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Myokine Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location contact

Camille ROLLAND-DEBORD

PRINCIPAL_INVESTIGATOR

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,

Treatment and study plan

muscle evaluation

Diagnostic Test

The investigators will evaluate the muscle mass and muscle strenght for all patients included

Dosage

Biological

Evaluation of the cinetic of biomarkers during exercise

Other names: Others dosages at rest only, Dosage of biomarkers at rest and after exercise

cardiopulmonary exercise test

Diagnostic Test

CPET

Questionnaire and Physical Exam

Combination Product

Evaluating dyspnea, anxiety, sleep, physical activity, quality of life

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    Variation of cytokine as IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) ; adipokines ; myokines

  2. Difference in muscle mass (kg) on impedancemetry according to the presence of sarcopenia

    Time frame: Baseline

  3. Difference on maximum aerobic capacity (VO2 max in L/mn) , according to the presence of sarcopenia

    Time frame: immediately after the exercise test

    Difference on physical activity

  4. Difference in fat mass (kg) on impedancemetry according to the presence of sarcopenia

    Time frame: At baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: MUDYSA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

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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