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)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Fibromyalgia; Electric Bike; Therapeutic Education; Chronic Pain; Adapted Physical Activity

Treatments: Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.

Study type: Interventional

Funder types: Other

Identifiers

NCT04318054

38RC19.128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Immediate intervention group

Experimental group

Description:

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).

Treatment:

Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.

Deferred intervention group

Other group

Description:

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).

Treatment:

Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.