Fibromyalgia and Specific Physical Activity

Study Overview
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Brief Summary
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Fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain. Usual treatment consists of multimodal care including physical activity. This dosage should be adapted to the patient's health needs. Currently recommended physical exercise is aerobic work associated with muscle reinforcement, without evidence of superiority of the efficacy of one over the other. Recommended dosage for aerobic exercises is 20 minutes (or twice 10 minutes), two to three times a week (70 - 80% of Theoretical Maximum Heart Rate). At the Vendee Departmental Hospital Center (CHD), adapted physical activity is proposed to fibromyalgia patientsby the associative group Siel Bleu. This physical activity, performed with patients suffering from different pathologies, is non specific for fibromyalgia context. In parallel, a preliminary study showed the interest of a lifestyle coaching for fibromyalgia patients, performed by physiotherapists, nurses and coaches specifically trainede. Another possibility seems to be personalized coaching with a physical activity adapted to the physical and organizational constraints of the patient, and specific to pathology. This solution would make it possible to adapt to the patient's choice of physical activities, to ensure a better adaptation to their physical and organizational constraints as well as a better individualized follow-up.

Official Title
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Fibromyalgia and Specific Physical Activity

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Specific Physical Activity
* Behavioral: Classic Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient Patient whose FIQ ≤ 59/100 Patient who can be followed for 12 months in the CETD Patient able to follow the adaptated physical activities proposed by Siel Bleu, on the physical and organizational level Patient with a smartphone and/or a computer (mac/pc) with an internet connection allowing the use of a tracking application linked to the activity tracker Patient with the ability to understand protocol and consenting to participate in this study Patient benefiting from a social cover Exclusion Criteria: Patient participating in an interventional trial within 3 months of enrollment Pregnant or lactating woman, or having the possibility to procreate without effective contraception Patient minor, under guardianship, curators or deprived of liberty Patient unable to follow the protocol, according to the judgment of the investigator, or refusing to use of digital applications Patient with contraindications to physical activity Patient having already followed the physical activities proposed by 'Siel Bleu

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific Physical Activity<br>Specific patient care in telephone coaching of fibromyalgia patients. | Other: Specific Physical Activity<br>* An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)<br>|
| Other: Classic Physical Activity<br>Classic patient care in common group of multipathological patients. | Behavioral: Classic Physical Activity<br>* One session per week in groups conducted by adaptated physical activities teachers of Siel Bleu association<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the interest of a specific physical activity program on patients' quality of life | Evolution of the Fibromyalgia Impact Questionnaire (FIQ) score (questionnaire of specific quality of life in the management of fibromyalgia patients) between the beginning of care (J0) and six months (M6) | 6 months after randomization |