Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.

Physical Activity Clinical Trial

— FIMOUV 1  

Official title:

Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736733
• Other study ID #: 18CH051
• Secondary ID: 2018-A01597-48
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: June 11, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 11, 2021
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient lived in t Loire (42) or Haute-Loire (43)
• 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 2 hours 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) or Haute-Loire (43) 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	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	Assessment of the impact of a 3-month program	Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).	at 3 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	at 3 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.	at 3 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.	at 3 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	at 3 months
Secondary	pain evaluation	assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)	at 3 months
Secondary	muscle power	evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.	at 3 months
Secondary	muscular endurance	evaluated by dynamometry on a stress platform (arms and legs).	at 3 months
Secondary	gas exchange measurement	evaluated during a stress test	at 3 months
Secondary	quantification of physical activity in meter-h/week	evaluated by the APAQ : Adult Physical Activity Questionnaire	at 3 months
Secondary	sedentary times in hours/day	evaluated by the APAQ : Adult Physical Activity Questionnaire	at 3 months
Secondary	daily energy expenditure	evaluated by actimetry	at 3 months
Secondary	time of physical activity	evaluated by actimetry	at 3 months
Secondary	physical inactivity	evaluated by actimetry	at 3 months
Secondary	patient adherence	number of sessions performed	at 3, 6 and 12 months
Secondary	Direct medical costs	consultations, examinations, hospitalizations in euros	at 3, 6 and 12 months
Secondary	Direct non-medical costs	transport	at 3, 6 and 12 months
Secondary	Cost of lost productivity	time not worked	at 3, 6 and 12 months