Exercise Capacity of Patients with Dermatomyosis

NCT03293615 | Terminated

• 1 other identifier: 6431
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Dermatomyositis (DM)

EXPERIMENTAL

Patients with dermatomyositis according to ENMC criteria

Other: exploration

Non-dermatomyositis inflammatory myopathies

ACTIVE COMPARATOR

Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria

Other: exploration

No myopathy

NO INTERVENTION

Patients without myopathy on muscle biopsy

Interventions

exploration OTHER

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

Dermatomyositis (DM); Non-dermatomyositis inflammatory myopathies

Eligibility Criteria

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

You may qualify if:

• Woman or man\> 18 years,
• Signature of informed consent,
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Meyer

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Dermatomyositis

Interventions

Space Flight

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Aviation; Transportation; Technology, Industry, and Agriculture

Study Officials

• Alain Meyer

  Les Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 26, 2017
• Study Start: November 28, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)