Home Based Personalized Training and Video Consultation in Mitochondrial Myopathies: Study of Efficacy and Tolerance.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized and mixed training program.
- Who it may be relevant to
- Registry conditions: Mitochondrial Myopathies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Video Consultation and Mitochondrial Myopathies: Study of Efficacy and Tolerance of a Personalized Training Program at Home
Overview
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 patients with functional limitations of activities. Patients with mitochondrial diseases have exercice intolerance with an increase of muscular weakness and fatigue after low exercice volume. Theses patients have functional limitations of activities. In order to establish an appropriate training programme, it will be important to define and consider the physical condition. The Society of Mitochondrial Medecine published recommandations for management of theses patients,However, theses recommandations do not allow them to propose a training program of what can be done. For these vulnerable patients, therapists are responsible fo advising a training programm without guidelines to establish its terms and conditions. In addition, some exercices do not appear to have been the subject of complete assessmeents. Regarding training programs (aerobic training, muscle reinforcement, miwed training), scientific literature shows a significant genetic and clinical variabilities, as well as a lack of data on clinical severity of included patients. In addition, the lack of informations regarding training effects of heteroplamy level limits our comprehension of mechanisms involved in adaptation of mitochondrial pool during training. Therefore, further reserchs on this subject are essential. It is necessary to offer these patients a follow-up and personalized training program, which are in adequation with daily life. Some publications call on specifics concepts which are not compatible with day-to-day life. The investigators think it will be useful to investigate training effects in order to have practival conclusions, easily reproducible at home by patients with simple and inexpensive equipment. In this context, video consultation could allow the close follow-up of these patients. The investigators hypothesize that a mixed training (endurance and muscle reinforcement), personalized, at home and followed by video consultation have positive effects on some physical criteria (such as musclar strength, tolerance to effort, functional abilities) without increasing heteroplasmy and creatine phosphokinase levels.
Interventions
- Procedure Personalized and mixed training program
Patients perform a personalized and mixed training program (endurance and muscle reinforcement), at home
Primary outcome measures
- Change of overall functional capacity of moving during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
Secondary outcome measures (12)
- Change of muscular strength of upper and lower limbs during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Change of muscular endurance of upper and lower limbs during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Change of functional abilities in walking during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Change of functional abilities during transferts during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Change of clinical severity of the disease during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Change of quality of life during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Change of tiredness felt during training period from 6 months (S0) to 9 (S12) and 12 (S24) months [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Check effects of a training program on clinical and biological tolerance, by assessing the modification of heteroplasmy level [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
- Check effects of a training program on clinical and biological tolerance, by regularly assessing the effort-related myalgia [Time frame: From 6 months (S0) to 12 months (S24)]
- Check effects of a training program on clinical and biological tolerance, by assessing the blood creatine phosphokinase levels which is a muscle damage marker [Time frame: From 0 (S-24) to 12 months (S24)]
- Establish a "dose-effect" relationship between the training frequency and effects on clinical parameters (strength, endurance and functionnal abilities such as global moving, walking and during transferts) [Time frame: From 0 (S-24) to 12 months (S24)]
- Check effect of a training program on reported physical condition by assessing the Recent Physical Activity Questionnaire (RPAQ). [Time frame: At 6 (S0), 9 (S12) and 12 (S24) months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT05346627 · 20-GIRCI-01