Fibromyalgia and Specific Physical Activity

Not Applicable

Terminated

• Conditions: Fibromyalgia
• Interventions: Other: Specific Physical Activity; Behavioral: Classic Physical Activity

• Registration Number: NCT03895086
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-03-29
• Study Start: 2020-02-13
• Status Verified: 2020-04
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-14
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specific Physical Activity	Specific Physical Activity	Specific patient care in telephone coaching of fibromyalgia patients.
Classic Physical Activity	Classic Physical Activity	Classic patient care in common group of multipathological patients.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Centre Hospitalier Départemental Vendée; 🇫🇷 La Roche-sur-Yon, France

Centre Hospitalier Universitaire; 🇫🇷 Nantes, France