Fibromyalgia and Specific Physical Activity

Fibromyalgia Clinical Trial

— FibrAPSpé  

Official title:

Fibromyalgia and Specific Physical Activity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03895086
• Other study ID #: CHD110-18
• Status: Terminated
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: January 14, 2021

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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)

Behavioral:
• Classic Physical Activity
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association

Locations

Country	Name	City	State
France	Centre Hospitalier Départemental Vendée	La Roche-sur-Yon
France	Centre Hospitalier Universitaire	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months after randomization