Impact of Sarcopenia on Dyspnea in Patients with Asthma (MUDYSA)

March 10, 2025 updated by: University Hospital, Clermont-Ferrand

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All the patient included in the study
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
Other Names:
  • Others dosages at rest only
  • Dosage of biomarkers at rest and after exercise
Diagnostic test: Cardiopulmonary exercise test
CPET
Combination product: Questionnaire and Physical Exam
Evaluating dyspnea, anxiety, sleep, physical activity, quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline (at rest) to the end of the exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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 on physical activity
immediately after the exercise test
Difference in fat mass (kg) on impedancemetry according to the presence of sarcopenia
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Camille ROLLAND-DEBORD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI 2023 ROLLAND-DEBORD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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