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Fibromyalgia and Specific Physical Activity (FibrAPSpé)

C

Centre Hospitalier Departemental Vendee

Status

Terminated

Conditions

Fibromyalgia

Treatments

Behavioral: Classic Physical Activity
Other: Specific Physical Activity

Study type

Interventional

Funder types

Other

Identifiers

NCT03895086
CHD110-18

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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"

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

Specific Physical Activity
Experimental group
Description:
Specific patient care in telephone coaching of fibromyalgia patients.
Treatment:
Other: Specific Physical Activity
Classic Physical Activity
Other group
Description:
Classic patient care in common group of multipathological patients.
Treatment:
Behavioral: Classic Physical Activity

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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