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

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.

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Fibromyalgia
• Intervention / Treatment: Other: Advice and recommendations of physical activity at home; Other: physical activity program

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fibromyalgia patients with 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.	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.
Other: fibromyalgia patients with physical activity at home; Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
pain evaluation	assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)	at 3 months
muscle power	evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.	at 3 months
muscular endurance	evaluated by dynamometry on a stress platform (arms and legs).	at 3 months
gas exchange measurement	evaluated during a stress test	at 3 months
quantification of physical activity in meter-h/week	evaluated by the APAQ : Adult Physical Activity Questionnaire	at 3 months
sedentary times in hours/day	evaluated by the APAQ : Adult Physical Activity Questionnaire	at 3 months
daily energy expenditure	evaluated by actimetry	at 3 months
time of physical activity	evaluated by actimetry	at 3 months
physical inactivity	evaluated by actimetry	at 3 months
patient adherence	number of sessions performed	at 3, 6 and 12 months
Direct medical costs	consultations, examinations, hospitalizations in euros	at 3, 6 and 12 months
Direct non-medical costs	transport	at 3, 6 and 12 months
Cost of lost productivity	time not worked	at 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David HUPIN, MD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): June 11, 2021

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: sedentary time
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 18CH051; 2018-A01597-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No