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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific Physical Activity | Experimental | Specific patient care in telephone coaching of fibromyalgia patients. |
|
| Classic Physical Activity | Other | Classic patient care in common group of multipathological patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Physical Activity | Other | 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) |
| 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). The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms. | 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas RULLEAU | CHD Vendée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Départemental Vendée | La Roche-sur-Yon | France | ||||
| Centre Hospitalier Universitaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32943085 | Background | 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. |
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Only 1 participant was randomized to the treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
early termination study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data not collected - study stopped prematurely |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only one patient was enrolled in the study - data was not collected | Posted | 6 months after randomization |
|
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Death, serious adverse events and other (non serious adverse events) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Thomas RULLEAU | Maison de la Recherche en Santé | 6 35 55 03 35 | +33 | thomas.rulleau@chu-nantes.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2019 | Jun 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Classic Physical Activity | Behavioral | One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association |
|
| Nantes |
| France |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| OG001 | 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 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D009422 |
| Nervous System Diseases |