Trial record 41 of 134 for:    fibromyalgia | Open Studies | Interventional Studies

Life Quality Determinant Assessment of Fibromyalgia Patients (FIBROQUALLIFE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2015 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02482714
First received: June 18, 2015
Last updated: June 23, 2015
Last verified: June 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on questionnary Short Form (36) SF36 [ Time Frame: 6th month ] [ Designated as safety issue: No ]
  • Measurement of displacement with Global Positioning System GPS [ Time Frame: 6th month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (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

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02482714

Contacts
Contact: Jehan Lecocq, MD 0369550660 ext 0033 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 
Study First Received: June 18, 2015
Last Updated: June 23, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on July 28, 2016