Fibromyalgia and Specific Physical Activity

NCT03895086 | Terminated Results

• 1 other identifier: CHD110-18
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Specific Physical Activity

EXPERIMENTAL

Specific patient care in telephone coaching of fibromyalgia patients.

Other: Specific Physical Activity

Classic Physical Activity

OTHER

Classic patient care in common group of multipathological patients.

Behavioral: Classic Physical Activity

Interventions

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)

Specific Physical Activity

Classic Physical Activity BEHAVIORAL

One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association

Classic Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Location

Centre Hospitalier Universitaire

Nantes, France

Location

Related Publications (1)

• 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.

  PMID: 32943085 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Mr Thomas RULLEAU
• Organization: Maison de la Recherche en Santé

thomas.rulleau@chu-nantes.fr

6 35 55 03 35

Study Officials

• Thomas RULLEAU

  CHD Vendée

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: March 29, 2019
• Study Start: February 13, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: April 23, 2026
• Results First Posted: September 23, 2024

Record last verified: 2026-04

Locations

FR (2)