NCT03640806

QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia

Completed NA Last updated 14 August 2020

What this trial tests

NA trial testing PHYSICAL ACTIVITY in Fibromyalgia in 80 participants. Completed in 10 August 2020.

Timeline

15 November 2018

Primary endpoint
30 June 2020

10 August 2020

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	80
Start date	15 November 2018
Primary completion	30 June 2020
Estimated completion	10 August 2020
Sites	1 location across France

Drugs / interventions tested

• PHYSICAL ACTIVITY

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fibromyalgia affects at least 4% of the population. This chronic painful pathology is a source of social exclusion with a major impact on professional activity;

To our knowledge, no study has demonstrated with sufficient evidence the effectiveness of the practice of well-defined adapted physical activity (APA) via a reproducible program of physical activity that has been the mechanisms of action that underlie this efficacy by biology and functional brain imaging (PET CT) in this context.

In addition, the publications mention recruitment difficulties, a high drop-out rate and a difficult maintenance of the benefits of physical activity in the long term, or even a return to the initial level after a few months.

The programs evaluated do not seem to take into account the peculiarities of patients, their coping coping strategies, associated with chronic pain and disability . In order to reinforce the durability of the benefits of our intervention, we make modulating factors of "coping" styles of therapeutic targets in their own right, as well as muscular strength, aerobic capacity or flexibility. Thus, cognitive-behavioral therapy (CBT) procedures validated in the treatment of chronic pain are adapted and transposed to our APA program in order to propose specific strategies.

"Fibromy'activ" aims to act upstream and downstream of the formation of health inequalities found in the population suffering from fibromyalgia and favored by the natural evolution of the disease: These workshops tend to favorably influence the course of life and to define a reproducible interdisciplinary protocol.

It is a question of making accessible and reproducible the practice of adapted physical activity (APA), non-medicinal therapeutic recommended by the HAS since 2010 , by the EULAR in 2016, but not refunded, poorly protocolized therefore not reproducible and little implementation. It is part of the spirit of the amended Health Act with the coming into force of the application decree since March 2017 "Physical Prescription".

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and mechanism of supervised adapted physical activity on quality of life for patients with fibromyalgia: single-center, prospective, randomised clinical and neuroimaging study.
   Ranque S, Laurin J, Linguraru MG, Jiang Z, et al · · 2026 · PMID 41634061 · DOI 10.1038/s41598-025-33433-5