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)
Unknown statusNot applicableNCT04318054
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 activity coupled with therapeutic education workshop.
Study details
- Official title
- 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.
- Conditions
- Fibromyalgia
- Chronic Pain
- Adapted Physical Activity
- Therapeutic Education
- Electric Bike
- Interventions
- Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
- Sponsor
- University Hospital, Grenoble
- Start date
- 2020-03-15
- Primary completion
- 2022-03-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04318054