Routine Health Care of Patients With FSHD (FSHD)

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ClinicalTrials.gov Identifier: NCT02622438

Recruitment Status : Recruiting

First Posted : December 4, 2015

Last Update Posted : April 13, 2020

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Sponsor:

Information provided by (Responsible Party):

University Hospital, Montpellier

Tracking Information

First Submitted Date ^ICMJE

November 30, 2015

First Posted Date ^ICMJE

December 4, 2015

Last Update Posted Date

April 13, 2020

Actual Study Start Date ^ICMJE

April 19, 2015

Estimated Primary Completion Date

March 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]
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 ]
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 ]
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 ]

Original Primary Outcome Measures ^ICMJE

Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg [ Time Frame: 6 months after inclusion ]
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 ]
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 ]
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 ]

Change History

Current Secondary Outcome Measures ^ICMJE

Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: the day of inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 12 months after inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 24 months after inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 36 months after inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 72 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: the day of inclusion ]
Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 12 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 24 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 36 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 72 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: the day of inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 12 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 24 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 36 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 72 months after inclusion ]

Original Secondary Outcome Measures ^ICMJE

Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: the day of inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 6 months after inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 12 months after inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 24 months after inclusion ]
Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire) [ Time Frame: 36 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: the day of inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 6 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 12 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 24 months after inclusion ]
Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire) [ Time Frame: 36 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: the day of inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 6 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 12 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 24 months after inclusion ]
Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests [ Time Frame: 36 months after inclusion ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Routine Health Care of Patients With FSHD

Official Title ^ICMJE

Course and Follow up of Patients Affected by Facioscapulohumeral Dystrophy

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.

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition ^ICMJE

Primary Disease Fascioscapulohumeral Dystrophy (FSHD)

Intervention ^ICMJE

Other: Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.

Study Arms ^ICMJE

Course and follow up of patients affected by FSHD

Intervention: Other: Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Estimated Study Completion Date ^ICMJE

March 2025

Estimated Primary Completion Date

March 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

7 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Jacques MERCIER, MD PhD

jacques.mercier@umontpellier.fr

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02622438

Other Study ID Numbers ^ICMJE

9371

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

University Hospital, Montpellier

Study Sponsor ^ICMJE

University Hospital, Montpellier

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jacques MERCIER, MD PhD

CHRU de Montpellier

PRS Account

University Hospital, Montpellier

Verification Date

April 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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