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
1 other identifier
interventional
56
0 countries
N/A
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 activity coupled with therapeutic education workshop.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2020
CompletedStudy Start
First participant enrolled
March 15, 2020
CompletedFirst Posted
Study publicly available on registry
March 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMarch 23, 2020
March 1, 2020
2 years
January 24, 2020
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) at 6 months compared to baseline.
6 months
Secondary Outcomes (20)
Evaluation of the kinetic of the evolution at the inclusion, at short-term (3 months), at medium-term (6 months) and at long-term (12 months) of the FIQ (Fibromyalgia Impact Questionnaire).
3, 6 and 12 months
Compare the percentage of patients who achieve an FIQ<39 at 6 months (threshold defining an fibromyalgia impact weak).
6 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
3, 6 and 12 months
- +15 more secondary outcomes
Study Arms (2)
Immediate intervention group
EXPERIMENTALfibromyalgia 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
OTHERDeferred 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).
Interventions
fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Wolfe F. Fibromyalgia: the clinical syndrome. Rheum Dis Clin North Am. 1989 Feb;15(1):1-18.
PMID: 2644671BACKGROUNDCazzola M, Atzeni F, Salaffi F, Stisi S, Cassisi G, Sarzi-Puttini P. Which kind of exercise is best in fibromyalgia therapeutic programmes? A practical review. Clin Exp Rheumatol. 2010 Nov-Dec;28(6 Suppl 63):S117-24. Epub 2010 Dec 22.
PMID: 21176431RESULTPeterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.
PMID: 27299435RESULTGojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.
PMID: 22005715RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Maindet, MD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2020
First Posted
March 23, 2020
Study Start
March 15, 2020
Primary Completion
March 30, 2022
Study Completion
February 1, 2023
Last Updated
March 23, 2020
Record last verified: 2020-03