Exercise Capacity of Patients With Dermatomyosis (MIDE)

Exercise Capacity of Patients With Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatomyositis
• Intervention / Treatment: Other: exploration

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain Meyer, MD; Phone Number: 00333 6 76 95 31 67; Email: alain.meyer1@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Meyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermatomyositis (DM); Patients with dermatomyositis according to ENMC criteria	Other: exploration; Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.
Active Comparator: Non-dermatomyositis inflammatory myopathies; Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria	Other: exploration; Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.
No Intervention: No myopathy; Patients without myopathy on muscle biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Alain Meyer, Les Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Polymyositis; Myositis; Dermatomyositis
• Other Study ID Numbers: 6431

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