Fibromyalgia and Specific Physical Activity

NCT ID: NCT03895086

Last Updated: 2025-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2021-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Specific Physical Activity

Specific patient care in telephone coaching of fibromyalgia patients.

Group Type EXPERIMENTAL

Specific Physical Activity

Intervention Type 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)

Classic Physical Activity

Classic patient care in common group of multipathological patients.

Group Type OTHER

Classic Physical Activity

Intervention Type BEHAVIORAL

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

Interventions

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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)

Intervention Type OTHER

Classic Physical Activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas RULLEAU

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée

Locations

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Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier Universitaire

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 32943085 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CHD110-18

Identifier Type: -

Identifier Source: org_study_id

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