Clinical trial NCT03895086: Fibromyalgia and Specific Physical Activity
Official title: Fibromyalgia and Specific Physical Activity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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"

Primary outcomes:
measure: Compare the Interest of a Specific Physical Activity Program on Patients' Quality of Life
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHD Vendée
name: Thomas RULLEAU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rulleau T, Planche L, Etcheverrigaray F, Dorion A, Kacki N, Miot M, Liaigre A, Ganem Y, Schmidt A, Taddei F, Acapo S, Nizard J, Pluchon YM. Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial. Trials. 2020 Sep 17;21(1):800. doi: 10.1186/s13063-020-04730-3.