NCT02482714

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

4.5 years

First QC Date

June 18, 2015

Last Update Submit

August 31, 2021

Conditions

Fibromyalgia

Keywords

Quality of LifePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)

    6th month

Secondary Outcomes (2)

  • Score on questionnary Short Form (36) SF36

    6th month

  • Measurement of displacement with Global Positioning System GPS

    6th month

Study Arms (2)

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

Physical activity.BEHAVIORAL

Have subject do moderate physical activity.

Club structureRehab Institute

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jehan Lecocq, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 26, 2015

Study Start

September 1, 2015

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

September 8, 2021

Record last verified: 2021-08

Locations

FR(1)