Efficiency of an Optimized Care Organization in Fibromyalgia Patients: The From Intent to Move (FIMOUV) Study Protocol of a Randomized Controlled Trial

Abstract

Introduction: Fibromyalgia (FM) is characterized by multiple symptoms including pain, fatigue, and sleep disorders, altering patient's quality of life. In the absence of effective pharmacological therapy, the last European guidelines recommend a multidisciplinary management based on exercise and education. Thus, our main objective was to measure the effectiveness of a healthcare organization offering a specific program of adapted physical activity combined with a therapeutic education program for FM patients. Methods and Analysis: The From Intent To Move (FIMOUV) study will recruit 330 FM patients randomized into two groups: test and control. The test group will benefit from a 1-month mixed exercise training program supervised at the hospital, followed by 2 months in a community-based relay in a health-sport structure. In addition, each of the two groups will benefit from therapeutic patient education sessions. The main endpoint is the measurement of the level of physical activity by accelerometry at 1 year. The secondary endpoints concern adherence to the practice of physical activity, impact on lifestyle, state of health, and physical capacity, as well as an estimate of the budgetary impact of this management strategy. Discussion: This interventional research will allow us to assess the evolution of behaviors in physical activity after an FM syndrome management based solely on patient education or based on a supervised and adapted practice of physical activity associated with this same therapeutic education program. It seems to be the first study evaluating the impact of its intervention on objective data for measuring physical activity and sedentary behavior via accelerometry among FM patients. Trial registration: ClinicalTrials.gov NCT04107948.

Keywords: accelerometry; behavior in physical activity; care organization; exercise; fibromyalgia; patient education.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Colas, Goutte, Creac'h, Fontana, Vericel, Manzanares, Peuriere, Akrour, Martin, Presles, Barth, Guyot, Garros, Trombert, Massoubre, Roche, Féasson, Marotte, Cathebras and Hupin.

Figures

Figure 1

Project collaborators mapping. THGL: Territorial Hospital Group of Loire.

Figure 2

Study design of FIMOUV. THGL, Territorial Hospital Group of Loire.

Figure 3

FIMOUV program intervention. (A) Modalities of aerobic training during the first month of intervention. Each session starts with 10 min warmup and ends with 10 min cooldown. *A continuous training at VT1 can be proposed if the subject's physical capacity does not allow the increase in workloads, as they are made on interval training. (a;b) corresponds to each session of the week; VT1: ventilatory threshold 1; VT2: ventilatory threshold 2. (B) Modalities of strength training during the first month of intervention. *Load maximum 50% of 1-repetition maximum if pain evaluation <4/10 at the start of the session. RPE: rating of perceived exertion, Borg modified scale. (C) Modalities of relaxation and flexibility training during the first month of intervention. *Hospital Anxiety and Depression Scale >8 for anxiety item. $Fatigue evaluation >7/10 at the start of the session. RHR: resting heart rate. (D) Modalities of therapeutic education program during the first month of intervention.