Impact of Sarcopenia on Dyspnea in Patients With Asthma

NCT06870890 | Not Yet Recruiting

• 1 other identifier: AOI 2023 ROLLAND-DEBORD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia; Asthma; Dyspnea; Dyspnea; Asthmatic; Cytokines; Adipokines; Myokine; Muscle Disorder

Keywords

Asthma; Sarcopenia; Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

  Baseline

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

  immediately after the exercise test

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

  At baseline

Study Arms (1)

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

Interventions

muscle evaluation DIAGNOSTIC_TEST

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

All the patient included in the study

Dosage BIOLOGICAL

Evaluation of the cinetic of biomarkers during exercise

Also known as: Others dosages at rest only, Dosage of biomarkers at rest and after exercise

All the patient included in the study

Cardiopulmonary exercise test DIAGNOSTIC_TEST

CPET

All the patient included in the study

Questionnaire and Physical Exam COMBINATION_PRODUCT

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

All the patient included in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Sarcopenia; Asthma; Dyspnea; Muscular Diseases

Interventions

Exercise Test; Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Musculoskeletal Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Camille ROLLAND-DEBORD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: March 25, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)