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Routine Health Care of Patients With FSHD (FSHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02622438
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Disease Fascioscapulohumeral Dystrophy (FSHD) Other: Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient. Not Applicable

Detailed Description:
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 6 months and annually for a period of six years. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Course and Follow up of Patients Affected by Facioscapulohumeral Dystrophy
Actual Study Start Date : April 19, 2015
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025
Arms and Interventions
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Arm Intervention/treatment
Course and follow up of patients affected by FSHD Other: Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.


Outcome Measures
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Primary Outcome Measures :
  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: 12 months after 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: 24 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: 36 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: 72 months after inclusion ]

Secondary Outcome Measures :
  1. Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 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: 72 months after inclusion ]
  6. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: the day of inclusion ]
  7. Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 12 months after inclusion ]
  8. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 24 months after inclusion ]
  9. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 36 months after inclusion ]
  10. Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 72 months after inclusion ]
  11. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: the day of inclusion ]
  12. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 12 months after inclusion ]
  13. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 24 months after inclusion ]
  14. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 36 months after inclusion ]
  15. Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 72 months after inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622438


Contacts
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Contact: Jacques MERCIER, MD PhD jacques.mercier@umontpellier.fr

Locations
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France
Montpellier University Hospital- Saint Eloi Hospital Recruiting
Montpellier, Languedoc-Roussillon, France, 34294
Contact: Jacques JM Mercier, MD, PhD    33(4)67335908    jacques.mercier@univ-montp1.fr   
Principal Investigator: Jacques mercier, MD PhD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Jacques MERCIER, MD PhD CHRU de Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02622438    
Other Study ID Numbers: 9371
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Keywords provided by University Hospital, Montpellier:
FSHD
Usual care performed at Montpellier hospital
Muscle function
Antioxidants
 Oxidative stress
Quality of life
Physical activities, development of food-based dietary guidelines
Co-morbidity