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Fibromyalgia and Specific Physical Activity (FibrAPSpé)

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ClinicalTrials.gov Identifier: NCT03895086
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Specific Physical Activity Behavioral: Classic Physical Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fibromyalgia and Specific Physical Activity
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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)

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




Primary Outcome Measures :
  1. Compare the interest of a specific physical activity program on patients' quality of life [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patient
  • Patient whose FIQ ≤ 31/100
  • 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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895086


Contacts
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Contact: Chloé MOREAU 0251446572 ext +33 chloe.moreau@chd-vendee.fr

Locations
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France
Centre Hospitalier Départemental Vendée Not yet recruiting
La Roche-sur-Yon, France
Principal Investigator: Thomas RULLEAU         
Centre Hospitalier Universitaire Not yet recruiting
Nantes, France
Principal Investigator: Julien NIZARD         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Thomas RULLEAU CHD Vendée

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03895086     History of Changes
Other Study ID Numbers: CHD110-18
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases