Clinical trial NCT04318054: 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)
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Adapted Physical Activity
Therapeutic Education
Electric Bike
Keywords: fibromyalgia
chronic pain
adapted physical activity
therapeutic education
electric bike
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Immediate 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).
Primary purpose: SUPPORTIVE_CARE

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.

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" accompanying, the EULAR (European League Against Reumatism) recommends the physical activity in first intention. Thus, physical reconditioning has an important place in fibromyalgia. Aerobic conditioning or reconditioning programs for effort induce for some patients a benefit on quality of life, tiredness and pain. In France, these programmes are mostly carried out in "follow-up and rehabilitation" type care structures.

Outdoor exercise re-training with the Intelligent Electric Bike for Health combined with therapeutic education sessions are proposed in the study. These activities, adapted to each group and patient, can best achieve the objective in an ambulatory format closer to the patient's daily life.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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).
timeFrame: 3, 6 and 12 months
measure: Compare the percentage of patients who achieve an FIQ<39 at 6 months (threshold defining an fibromyalgia impact weak).
timeFrame: 6 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
timeFrame: 3, 6 and 12 months
measure: Improve the global quality of life
timeFrame: 3, 6 and 12 months
measure: Improve self-esteem
timeFrame: 3, 6 and 12 months
measure: Improve the mood
timeFrame: 3, 6 and 12 months
measure: Diminuate the health care consumption of the subjects at 3, 6 and 12 months compared to baseline.
timeFrame: 3, 6 and 12 months
measure: Improve the perception of the impact of the disease in the relations with close relations
timeFrame: 3, 6 and 12 months
measure: Study the impact of the Fibrovelis program on the evolution of the muscular parameter.
timeFrame: 3 months (second to last trip of the intervention program).
measure: Study the impact of the Fibrovelis program on the evolution of cardio-respiratory physiological efficiency parameter.
timeFrame: 3 months (second to last trip of the intervention program).
measure: Evaluate the remanence of the long-term effect for the immediate intervention group
timeFrame: 18 months
measure: Evaluate the effect size of the intervention between 12 and 18 months for the diferred intervention group.
timeFrame: 12 and 18 months
measure: In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the muscular power parameters.
timeFrame: 3 months
measure: In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the cardio respiratory parameters.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Caroline Maindet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F. Fibromyalgia: the clinical syndrome. Rheum Dis Clin North Am. 1989 Feb;15(1):1-18.
citation: Cazzola 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.
citation: Peterman 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.
citation: Gojanovic 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.