Fibromyalgia
Conditions
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.
Interventions
OTHERSpecific 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)
BEHAVIORALClassic Physical Activity
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Interest of a Specific Physical Activity Program on Patients' Quality of Life | 6 months after randomization | 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). The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORThomas RULLEAU
CHD Vendée
Participant flow
Pre-assignment details
Only 1 participant was randomized to the treatment
Participants by arm
| Arm | Count |
|---|---|
| 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) | 0 |
| 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 | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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). The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms.
Time frame: 6 months after randomization
Population: Only one patient was enrolled in the study - data was not collected