Exercise Capacity of Patients with Dermatomyosis

Last updated: September 6, 2024
Sponsor: University Hospital, Strasbourg, France
Overall Status: Terminated

Phase

N/A

Condition

Collagen Vascular Diseases

Idiopathic Inflammatory Myopathies

Connective Tissue Diseases

Treatment

exploration

Clinical Study ID

NCT03293615
6431
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Woman or man> 18 years,

  • Signature of informed consent,

  • Muscle biopsy for suspicion of recent inflammatory myopathy (<6 months) or forexclusion 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 andii) normal neuromuscular examination, iii) no increase in blood creatine kinaselevel, iv) absence of electromyographic abnormality, v) histological Muscle mass.

Exclusion

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 emergencysituation, difficulty in understanding the subject, ...),

  • Subject under safeguard of justice,

  • Subject under tutelage or under curators,

  • Pregnancy (positive pregnancy test)

  • Breastfeeding.

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: exploration
Phase:
Study Start date:
November 28, 2019
Estimated Completion Date:
September 01, 2024

Connect with a study center

  • Meyer

    Strasbourg, 67000
    France

    Site Not Available

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