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Trial record 17 of 124 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies

Life Quality Determinant Assessment of Fibromyalgia Patients (FIBROQUALLIFE)

This study is currently recruiting participants.
Verified September 2017 by University Hospital, Strasbourg, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT02482714
First Posted: June 26, 2015
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose
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 Intervention
Fibromyalgia Behavioral: Physical activity.

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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

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

Estimated Enrollment: 100
Actual Study Start Date: September 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02482714     History of Changes
Other Study ID Numbers: 6118
First Submitted: June 18, 2015
First Posted: June 26, 2015
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