Fibromyalgia and Specific Physical Activity (FibrAPSpé)
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|ClinicalTrials.gov Identifier: NCT03895086|
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : July 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Specific Physical Activity Behavioral: Classic Physical Activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fibromyalgia and Specific Physical Activity|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Specific Physical Activity
Specific patient care in telephone coaching of fibromyalgia patients.
Other: 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.
Behavioral: Classic Physical Activity
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
- Compare the interest of a specific physical activity program on patients' quality of life [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895086
|Contact: Chloé MOREAU||0251446572 ext +email@example.com|
|Centre Hospitalier Départemental Vendée||Not yet recruiting|
|La Roche-sur-Yon, France|
|Principal Investigator: Thomas RULLEAU|
|Centre Hospitalier Universitaire||Not yet recruiting|
|Principal Investigator: Julien NIZARD|
|Principal Investigator:||Thomas RULLEAU||CHD Vendée|