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Life Quality Determinant Assessment of Fibromyalgia Patients (FIBROQUALLIFE)

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ClinicalTrials.gov Identifier: NCT02482714
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Physical activity. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Life Quality Determinant Assessment of Fibromyalgia Patients Related to Health Devices
Actual Study Start Date : September 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rehab Institute
This group will do some physical activity in a specialized institute
Behavioral: Physical activity.
Have subject do moderate physical activity.

Active Comparator: Club structure
This group will do some physical activity in a club.
Behavioral: Physical activity.
Have subject do moderate physical activity.




Primary Outcome Measures :
  1. Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia) [ Time Frame: 6th month ]

Secondary Outcome Measures :
  1. Score on questionnary Short Form (36) SF36 [ Time Frame: 6th month ]
  2. Measurement of displacement with Global Positioning System GPS [ Time Frame: 6th month ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age group : 20 to 60
  • Male or female
  • American College of Rheumatology criteria
  • Social Security beneficiary
  • Informed consent of the patient
  • Patient informed of the medical examination prior to inclusion
  • Patient residing in the Bas-Rhin area

Exclusion Criteria:

  • No medical objections to performing a stress test
  • Any cardio-respiratory and musculoskeletal affection preventing physical activity
  • Any particular clinical form disease
  • Patient in situation of exclusion
  • Subject incapacity to understand informed consent
  • Patient deprived of freedom or under the protection of a conservator
  • Pregnancy or breast-feeding

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): NCT02482714


Contacts
Contact: Jehan Lecocq, MD 0369550660 ext 0033 jehan.lecocq@chru-strasbourg.fr

Locations
France
University Hospital, Strasbourg, france Recruiting
Strasbourg, France, 67000
Contact: Jehan LECOCQ       jehan.lecocq@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jehan Lecocq, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02482714     History of Changes
Other Study ID Numbers: 6118
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Keywords provided by University Hospital, Strasbourg, France:
Quality of Life
Physical Activity

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases