Status:
RECRUITING
Home Based Personalized Training and Video Consultation in Mitochondrial Myopathies: Study of Efficacy and Tolerance.
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Mitochondrial Myopathies
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Positive effect of physical activity on health arouses a strong interest at international level and is developped within the scope of national programs. Recommandations exist but must be designed for ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- patient over 18 years-old,
- with genetically-confirmed mitochondria myopathy,
- with mitochondrial DNA mutation,
- clinically dominant myopathic-like disorders according investigator,
- able to walk with or without assistance,
- likely to be followed for at least one year without interruption by video consultation (implying internet connexion with computer and camera or smartophone),
- having given the written and informed consent and being social security member.
- For patients in childbearing age, she must have used at least one month if reliable contraception.
- Exclusion criteria:
- patient wih pathology or comorbidity incompatible with the conduct of the study according the investigator during inclusion visit,
- patient with physical condition incompatible with training program according investigator during inclusion visit,
- patient having a physical tiredness and/or myalgia during last week with an intensity of 6 on visual and analog scale,
- pregnant or nursing patient,
- patient expecting pregnancy during the course of the study,
- patient protected by law or under guardianship or curatorship, or not able to participate in a clinical trial under L.1121-16 article of French Public Health Regulations.
Exclusion
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05346627
Start Date
December 20 2022
End Date
June 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
CHU de Nice
Nice, Alpes Maritimes, France, 06000