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Completed

NCT Number: NCT02622438

Routine Health Care of Patients With FSHD

On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

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Key information

Conditions

Primary Disease Fascioscapulohumeral Dystrophy (FSHD) Behavior Motor Activity

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital- Saint Eloi Hospital

Montpellier, Languedoc-Roussillon, 34294, France

About this study

This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 12 months and annually. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital. A statistical analysis will be performed at 3-years follow-up

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Molecular and clinical diagnosis for FSHD
  • patients, men and women aged > 7 years,

Exclusion criteria

  • pregnant women
  • Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
  • Major protected by law (guardianship, curatorship or under judicial protection)

Treatment and study plan

Followed with an initial assessment, 12 months and followed annually corresponding to the usual follow-up of the patient.

Other

Primary outcomes

  1. Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg

    Time frame: 1 day (the day of inclusion)

  2. Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg

    Time frame: 12 months after inclusion

  3. Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg

    Time frame: 24 months after inclusion

  4. Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg

    Time frame: 36 months after inclusion

  5. Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg

    Time frame: 48 months after inclusion

  6. Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg

    Time frame: 60 months after inclusion

Secondary outcomes

  1. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)

    Time frame: 1 day (the day of inclusion)

  2. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)

    Time frame: 12 months after inclusion

  3. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)

    Time frame: 24 months after inclusion

  4. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)

    Time frame: 36 months after inclusion

  5. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)

    Time frame: 48 months after inclusion

  6. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)

    Time frame: 60 months after inclusion

  7. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)

    Time frame: 1 day (the day of inclusion)

  8. Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)

    Time frame: 12 months after inclusion

  9. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)

    Time frame: 24 months after inclusion

  10. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)

    Time frame: 36 months after inclusion

  11. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)

    Time frame: 48 months after inclusion

  12. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)

    Time frame: 60 months after inclusion

  13. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests

    Time frame: 1 day (the day of inclusion)

  14. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests

    Time frame: 12 months after inclusion

  15. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests

    Time frame: 24 months after inclusion

  16. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests

    Time frame: 36 months after inclusion

  17. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests

    Time frame: 48 months after inclusion

  18. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests

    Time frame: 60 months after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Course and Follow up of Patients Affected by Facioscapulohumeral Muscular Dystrophy

Acronym: FSHD

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2015
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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