Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03640806
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2018-08-17
Brief Title:
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
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
Fibromyactiv 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
Fibromyactiv 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:
Fibromyactiv 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 7900 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 81 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
Fibromyactiv 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 7900 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 81 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
Fibromyactiv 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:
None
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?:
None