Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05346627

Video Consultation and Mitochondrial Myopathies: Study of Efficacy and Tolerance of a Personalized Training Program at Home

Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-18

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of a personalized training program for patients with mitochondrial myopathies, a condition causing exercise intolerance, muscle weakness, and fatigue. The goal is to understand how a mixed training program combining endurance and muscle strengthening, tailored for each patient and conducted at home, can improve physical abilities without worsening certain biological markers. This research aims to provide practical, home-based exercise guidance supported by video consultations, addressing the current lack of clear training recommendations for these patients. Participants will follow a personalized mixed training program at home, which includes both endurance and muscle reinforcement exercises. They will be monitored remotely through video consultations to ensure proper support and guidance. The study tracks their progress over a period from 6 months to 12 months, assessing the effects of training on muscle strength, endurance, functional mobility, and other clinical parameters. During the study, participants will undergo various assessments at 6, 9, and 12 months to measure changes in functional capacity, muscle strength and endurance, walking ability, and quality of life. Researchers will also monitor biological markers such as heteroplasmy levels and creatine phosphokinase to evaluate the safety and tolerance of the training. The study includes questionnaires about physical activity and tiredness to understand participants' condition and the training's impact.

CONDITIONS

Brief Title

Home Based Personalized Training and Video Consultation in Mitochondrial Myopathies: Study of Efficacy and Tolerance.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old
  • Genetically confirmed mitochondrial myopathy
  • Presence of mitochondrial DNA mutation
  • Clinically dominant myopathic-like disorders as determined by investigator
  • Able to walk with or without assistance
  • Likely to be followed for at least one year without interruption by video consultation with internet access and camera-enabled device
  • Given written informed consent and is a social security member
  • If of childbearing age, used reliable contraception for at least one month
Not Eligible

You will not qualify if you...

  • Pathology or comorbidity incompatible with study conduct as judged by investigator
  • Physical condition incompatible with training program as judged by investigator
  • Physical tiredness or muscle pain in the last week with intensity of 6 or higher on visual analog scale
  • Pregnant or nursing
  • Expecting pregnancy during the study
  • Protected by law, under guardianship or curatorship, or unable to participate under French Public Health Regulations L.1121-16

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 6 months

Participants perform a personalized and mixed training program (endurance and muscle reinforcement) at home, supported by video consultation.

1 baseline visit and 2 follow-up visits at 3 and 6 months

Follow-up

Duration - 6 months

Participants continue to be monitored for changes in functional capacity, muscular strength and endurance, quality of life, and tolerance of the training program.

1 follow-up visit at 9 months and 1 final visit at 12 months

Trial Site Locations

Total: 1 location

1

CHU de Nice

Nice, Alpes Maritimes, France, 06000

Actively Recruiting

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Research Team

S

Sabrina SACCONI

J

Jérémy GARCIA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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