Fibromyalgia and Specific Physical Activity (FibrAPSpé)

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.

Study Overview

• Status: Terminated
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Specific Physical Activity; Behavioral: Classic Physical Activity

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Roche-sur-Yon, France
    • Centre Hospitalier Departemental Vendee
  • Nantes, France
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Thomas RULLEAU, CHD Vendee

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): January 14, 2021
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: CHD110-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No