Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 12:49 PM
Study NCT ID:
NCT03640806
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
Official Title:
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia : Single-center, Prospective, Randomized With Biological and Cerebral Evaluation
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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".
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".
Detailed Description:
Fibromy'activ, an adapted physical activity program (APA) for patients with fibromyalgia, aims to provide lasting symptomatic relief, to favorably influence the life course, to identify mechanisms of action and to define a reproducible interdisciplinary protocol.
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 . In France, the prevalence of co-morbidities is increased in pain patients . There is a significant impact on health care systems. It is very expensive for the society of about € 7,900 / patient / year.
The fibromyalgia population managed at the Center for Assessment and Treatment of Pain CHU Timone (CETD), is characterized as follows: 50 years of average age, 85% of women with children in 80% of cases. 60% have a level of education lower than the baccalaureate, less than 30% have a professional activity. The duration of the pain before the first consultation is on average 8.1 years. The SPICE score is above average which indicates a higher level of precariousness. It is associated with dysfunctional pain adjustment strategies, psychological distress, low acceptance and poor quality of life. The characteristics are close to European studies
Natural evolution can lead to a total physical, psychological, social deconditioning. A link has been established between the severity of this pathology, a provider of precariousness and the poor physical condition, related to physical inactivity. The reverse has been described , so the practice of APA brings a significant reduction in symptoms .
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 (level of proof A), 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".
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 . In France, the prevalence of co-morbidities is increased in pain patients . There is a significant impact on health care systems. It is very expensive for the society of about € 7,900 / patient / year.
The fibromyalgia population managed at the Center for Assessment and Treatment of Pain CHU Timone (CETD), is characterized as follows: 50 years of average age, 85% of women with children in 80% of cases. 60% have a level of education lower than the baccalaureate, less than 30% have a professional activity. The duration of the pain before the first consultation is on average 8.1 years. The SPICE score is above average which indicates a higher level of precariousness. It is associated with dysfunctional pain adjustment strategies, psychological distress, low acceptance and poor quality of life. The characteristics are close to European studies
Natural evolution can lead to a total physical, psychological, social deconditioning. A link has been established between the severity of this pathology, a provider of precariousness and the poor physical condition, related to physical inactivity. The reverse has been described , so the practice of APA brings a significant reduction in symptoms .
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 (level of proof A), 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".
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: