Back to resultsLife Quality Determinant Assessment of Fibromyalgia Patients (FIBROQUALLIFE)
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity.
Sponsored by
About this trial
This is an interventional other trial for Fibromyalgia focused on measuring Quality of Life, Physical Activity
Eligibility 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
Sites / Locations
- University Hospital, Strasbourg, france
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehab Institute
Club structure
Arm Description
This group will do some physical activity in a specialized institute
This group will do some physical activity in a club.
Outcomes
Primary Outcome Measures
Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)
Secondary Outcome Measures
Score on questionnary Short Form (36) SF36
Measurement of displacement with Global Positioning System GPS
Full Information
NCT ID
NCT02482714
First Posted
June 18, 2015
Last Updated
August 31, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02482714
Brief Title
Life Quality Determinant Assessment of Fibromyalgia Patients
Acronym
FIBROQUALLIFE
Official Title
Life Quality Determinant Assessment of Fibromyalgia Patients Related to Health Devices
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulty
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Quality of Life, Physical Activity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehab Institute
Arm Type
Experimental
Arm Description
This group will do some physical activity in a specialized institute
Arm Title
Club structure
Arm Type
Active Comparator
Arm Description
This group will do some physical activity in a club.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity.
Intervention Description
Have subject do moderate physical activity.
Primary Outcome Measure Information:
Title
Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)
Time Frame
6th month
Secondary Outcome Measure Information:
Title
Score on questionnary Short Form (36) SF36
Time Frame
6th month
Title
Measurement of displacement with Global Positioning System GPS
Time Frame
6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jehan Lecocq, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
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Life Quality Determinant Assessment of Fibromyalgia Patients
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