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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
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
 (submitted: April 9, 2020)
  • 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
 (submitted: December 2, 2015)
  • 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
 (submitted: April 9, 2020)
  • 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
 (submitted: December 2, 2015)
  • 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
 (submitted: April 9, 2020)
200
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2015)
40
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 No
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 No
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