Medical Benefit Evaluation of Ambulatory Activity Combining Rehabilitation and Therapeutic Education, Using an Intelligent Electric Bike for the Health, for the Effort Rehabilitation and the Quality of Life Improvement for Patients Suffering of Moderate Fibromyalgia (FIBROVELIS) (Fibrovelis)
Fibromyalgia, Chronic Pain, Adapted Physical Activity
About this trial
This is an interventional supportive care trial for Fibromyalgia focused on measuring fibromyalgia, chronic pain, adapted physical activity, therapeutic education, electric bike
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 and over
- Patient available for a following of 18 months
- Patient available for go to sessions of Intelligent Electric Bike for the Health, 2 half-day by week during 8 weeks in the 2 months following the randomization.
- confirmed fibromyalgia according to the criteria of the American College of Rhumatology 2010 since at least one year with a stable treatment since at least 3 months.
- Patients with a score of 39 ≤ FIQ < 59 (moderate fibromyalgia impact)
- Patient in capacity to pedal on a bike outside.
- Patient who haven't contraindications at the practice of an moderate physical activity or bike (acute coronary pathology less than 2 years, locomotor problems of the spine or lower limbs incompatible with the bike practice).
- Weight lower than 125 kg (maximal load for the Intelligent Electric Bike for the Health).
- Patient having signed the written consent after appropriate information and delivery of the information note.
- Patient affiliated at the social security or beneficiary of such a scheme
Exclusion Criteria:
- Substantial variation of the therapeutic care in the 3 months previous the inclusion (change of drug class, beginning of physical reconditioning in an unit of follow-up and rehabilitation care, or a cognitive-behavioral technique)
- Patient with treatement which can deteriorate the attention
- Patient suffering of a serious chronic desease destabilized (acute coronary pathology and/ or CVA in the last 6 months, serious asthma, serious heart failure, respiratory, lung or kidney failure, progressive inflammatory rheumatic disease…)
- Women under contraception and with a pregnancy project
- Patient already includes in a research protocol involving the human person
- Protected persons
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Immediate intervention group
Deferred intervention group
fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, in the 2 months following the randomization, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
Deferred intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, one year after the inclusion, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).