Fibromyalgia and Specific Physical Activity (FibrAPSpé)
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific Physical Activity
Classic Physical Activity
Sponsored by
About this trial
This is an interventional other trial for Fibromyalgia
Eligibility Criteria
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"
Sites / Locations
- Centre Hospitalier Départemental Vendée
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Specific Physical Activity
Classic Physical Activity
Arm Description
Specific patient care in telephone coaching of fibromyalgia patients.
Classic patient care in common group of multipathological patients.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03895086
First Posted
March 28, 2019
Last Updated
April 28, 2021
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT03895086
Brief Title
Fibromyalgia and Specific Physical Activity
Acronym
FibrAPSpé
Official Title
Fibromyalgia and Specific Physical Activity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
impossible enrollement
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specific Physical Activity
Arm Type
Experimental
Arm Description
Specific patient care in telephone coaching of fibromyalgia patients.
Arm Title
Classic Physical Activity
Arm Type
Other
Arm Description
Classic patient care in common group of multipathological patients.
Intervention Type
Other
Intervention Name(s)
Specific Physical Activity
Intervention Description
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
Behavioral
Intervention Name(s)
Classic Physical Activity
Intervention Description
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
Primary Outcome Measure Information:
Title
Compare the interest of a specific physical activity program on patients' quality of life
Description
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)
Time Frame
6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas RULLEAU
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-Yon
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Nantes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32943085
Citation
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.
Results Reference
derived
Learn more about this trial
Fibromyalgia and Specific Physical Activity
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