Life Quality Determinant Assessment of Fibromyalgia Patients | NCT02482714

Studies
Life Quality Determinant Assessment of Fibromyalgia Patients

NCT02482714

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Sep 8, 2021Actual

Enrollment

93Actual

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

Physical activity.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulty

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Mar 12, 2020Actual

Completion Date

Mar 12, 2020Actual

First Submitted Date

Jun 18, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rehab Institute	Experimental	This group will do some physical activity in a specialized institute	Behavioral: Physical activity.
Club structure	Active Comparator	This group will do some physical activity in a club.	Behavioral: Physical activity.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity.	Behavioral	Have subject do moderate physical activity.	Club structure Rehab Institute

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)		6th month

Secondary Outcomes

Measure	Description	Time Frame
Score on questionnary Short Form (36) SF36		6th month
Measurement of displacement with Global Positioning System GPS		6th month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jehan Lecocq, MD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Strasbourg, france		Strasbourg		67000	France

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D009043	Motor Activity

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided