Exercise Capacity of Patients with Dermatomyosis

NCT ID: NCT03293615

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2024-09-01

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.

Conditions

Dermatomyositis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dermatomyositis (DM)

Patients with dermatomyositis according to ENMC criteria

Group Type: EXPERIMENTAL

exploration

Intervention Type: OTHER

Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

Non-dermatomyositis inflammatory myopathies

Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria

Group Type: ACTIVE_COMPARATOR

exploration

Intervention Type: OTHER

Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

No myopathy

Patients without myopathy on muscle biopsy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exploration

Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Meyer

Role: PRINCIPAL_INVESTIGATOR

Les Hôpitaux Universitaires de Strasbourg

Locations

Meyer

Strasbourg, , France

Countries

France

Other Identifiers

6431

Identifier Type: -

Identifier Source: org_study_id