Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Physical Activity Clinical Trial

— FIMOUV 2  

Official title:

Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107948
• Other study ID #: 18PH223
• Secondary ID: 2019-A02221-56
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: October 1, 2030

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: David HUPIN
• Phone: 0477828413
• Email: David.Hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

Description:

In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining: - an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town) - therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: October 1, 2030
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) = 13
• French writing and speaking
• Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion)
• Signature of informed consent

Exclusion Criteria:

• Cardiac or respiratory diseases that contraindicate the practice of physical activity
• Significant co-morbidities that contraindicate the practice of physical activity:

associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).

• Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Physical Activity

Intervention

Other:
• physical activity program
Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42), Haute-Loire (43) or Ardèche (07) for 2 months.
• Advice and recommendations of physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Locations

Country	Name	City	State
France	CH d'ANNONAY	Annonay
France	CH de Firminy	Firminy
France	CH de MONTBRISON	Montbrison
France	CH de Rive de Gier	Rive-de-Gier
France	CH de ROANNE	Roanne
France	CH du Gier	Saint Chamond
France	Chu Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity	Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph	12 months
Secondary	sedentary	Measure the durability of adhesion/therapeutic compliance of fibromyalgia patients based on an objective measurement of sedentary : average measured from 7 days of actimetry, Actigraph	12 and 24 months
Secondary	physical activity	Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph	0, 1, 3, 6, 12 and 24 months
Secondary	sedentary	Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph	0, 1, 3, 6, 12 and 24 months
Secondary	health status	measured with Patient Global Impression of Change (PGIC) : on a 7-point scale, rated from 1 for "much worse" to 7 for "much better". It is a simple and practical evaluation tool to use. The combination of the level of achievement via the Patient Global Impression of Change and the initial documentation of the patient's objectives via the shared educational assessment is a relevant and understandable approach for the patient.	0, 1, 3, 6, 12 and 24 months
Secondary	fatigue	assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7.; Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5	0, 1, 3, 6, 12 and 24 months
Secondary	Quality of sleep	assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score.; The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3.; In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.	0, 1, 3, 6, 12 and 24 months
Secondary	Anxiety and Depression	assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.	0, 1, 3, 6, 12 and 24 months
Secondary	pain catastrophizing	assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time	0, 1, 3, 6, 12 and 24 months
Secondary	pain evaluation	assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)	6 and 12 months
Secondary	fatigue evaluation	assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)	6 and 12 months
Secondary	muscle power	evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.	0, 1 and 3 months
Secondary	muscular endurance	evaluated by dynamometry on a stress platform (arms and legs).	0, 1 and 3 months
Secondary	gas exchange measurement	evaluated during a stress test	0, 1 and 3 months
Secondary	fatigue	evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex	0, 1 and 3 months
Secondary	quantification of physical activity in meter-h/week	evaluated by the APAQ : Adult Physical Activity Questionnaire	0, 1, 3, 6,12 and 24 months
Secondary	sedentary times in hours/day	evaluated by the APAQ : Adult Physical Activity Questionnaire	0, 1, 3, 6, 12 and 24 months
Secondary	patient adherence	number of sessions performed	6 and 12 months
Secondary	Direct medical costs	consultations, examinations, hospitalizations in euros	12 months
Secondary	Direct non-medical costs	transport	12 and 24 months
Secondary	Cost of lost productivity	time not worked	12 and 24 months