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Not yet recruiting NCT06870890

Impact of Sarcopenia on Dyspnea in Patients With Asthma

No phase Interventional Sarcopenia Asthma Dyspnea Dyspnea; Asthmatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: muscle evaluation, Dosage, Cardiopulmonary exercise test, Questionnaire and Physical Exam.
Who it may be relevant to
Registry conditions: Sarcopenia, Asthma, Dyspnea, Dyspnea; Asthmatic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test muscle evaluation
    The investigators will evaluate the muscle mass and muscle strenght for all patients included
  • Biological Dosage
    Evaluation of the cinetic of biomarkers during exercise
  • Diagnostic test Cardiopulmonary exercise test
    CPET
  • Combination product Questionnaire and Physical Exam
    Evaluating dyspnea, anxiety, sleep, physical activity, quality of life

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT06870890 · AOI 2023 ROLLAND-DEBORD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗