Status:
UNKNOWN
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)
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Fibromyalgia
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical a...
Detailed Description
Fibromyalgia is chronic pain syndrome expressed as fluctuacting musculotendinous or articular pain and chronic tiredness. Among the non-pharmacological treatments, apart the "psychological" accompanyi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04318054
Start Date
March 15 2020
End Date
February 1 2023
Last Update
March 23 2020
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