Exercise Capacity of Patients With Dermatomyosis

Not Applicable

Recruiting

• Conditions: Dermatomyositis
• Interventions: Other: exploration

• Registration Number: NCT03293615
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown.

The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Study Start: 2019-11-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Woman or man> 18 years,
• Signature of informed consent,
• Muscle biopsy for suspicion of recent inflammatory myopathy (<6 months) or for exclusion of neuromuscular pathology.

Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:

• "DM" group: DM according to the ENMC criteria;
• "other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
• Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.

Exclusion Criteria

• • Taking an immunomodulatory treatment within 6 months before inclusion,
• Paraneoplastic form of the disease,
• Presence of associated interstitial pneumonitis,
• Neuromuscular pathology different from inflammatory myopathy,
• Unbalanced cardiovascular disease,
• Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
• Subject under safeguard of justice,
• Subject under tutelage or under curators,
• Pregnancy (positive pregnancy test)
• Breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermatomyositis (DM)	exploration	Patients with dermatomyositis according to ENMC criteria
Non-dermatomyositis inflammatory myopathies	exploration	Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria

Primary Outcome Measures

Name	Time	Method
Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.	Baseline	This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy

Trial Locations

Locations (1)

Meyer; 🇫🇷 Strasbourg, France