Study Results
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View full resultsBasic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2020-02-13
2021-01-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Specific Physical Activity
Specific patient care in telephone coaching of fibromyalgia patients.
Specific Physical Activity
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)
Classic Physical Activity
Classic patient care in common group of multipathological patients.
Classic Physical Activity
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
Interventions
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Specific Physical Activity
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)
Classic Physical Activity
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
Eligibility Criteria
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Inclusion Criteria
* 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
* 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"
18 Years
ALL
No
Sponsors
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Centre Hospitalier Departemental Vendee
OTHER
Responsible Party
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Principal Investigators
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Thomas RULLEAU
Role: PRINCIPAL_INVESTIGATOR
CHD Vendée
Locations
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Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, , France
Centre Hospitalier Universitaire
Nantes, , France
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CHD110-18
Identifier Type: -
Identifier Source: org_study_id
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