FibromyalgiaNCT03640806
QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia
A study testing PHYSICAL ACTIVITY in people with Fibromyalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- PHYSICAL ACTIVITY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2018to 10 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subject, 18 years of age or older, not pregnant, not breastfeeding, not deprived of liberty;
- Subject with fibromyalgia meeting the criteria of the American College of Rheumatology (ACR)
- Subject managed by the Center for Assessment and Pain Management of CHU Timone or addressed to it in consultation / day hospital;
- Subject free from any general illness or serious psychiatric disorders, and any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology of the central nervous system, determined during the interrogation;
- Subject not having a history of alcoholism or drug addiction,
- Subject with no contraindication to PET scintigraphy (pregnancy and lactation),
Show all 11Show fewer
- Subject with no indication of physical activity;
- Subject whose general state and comprehension of French makes it possible to complete a questionnaire;
- Topic with average pain> 4/10 at EN
- Subject affiliated with Social Security
- Subject who has read, understood and signed informed consent after informing and accepting protocol rules
Who cannot join
- Major subject under legal protection or unable to express their consent: L1121-8 of the CSP
- Subject presenting a contraindication to the practice of physical activity, to scintigraphic scanning by PET,
- Subject deprived of liberty following a judicial or administrative decision
- Subject with psychiatric illness or Personality Disorder making group work difficult
- Subject refusing to participate in the study or not signing the consent
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
About this study
Official title: QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia : Single-center, Prospective, Randomized With Biological and Cerebral Evaluation
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.
Read more
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".
Read the 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".
- Conditions
- Fibromyalgia
- Being tested
- PHYSICAL ACTIVITY
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSICAL ACTIVITYOther
3 fibromyactiv workshops per week during the first 6 months, or 72 sessions. Each workshop lasts 2 hours of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| PHYSICAL ACTIVITY | Experimental | Standard support for 12 months (HAS 2010, EULAR 2016) 3 fibromyactiv workshops per week during the first 6 months, or 72 sessions. Each workshop lasts 2 hours of physical activity. Receives: Other: PHYSICAL ACTIVITY |
| CONTROL | No intervention | Standard care for 12 months (HAS 2010, EULAR 2016) with Pain Consultation every 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fibromyalgia Impact Questionnaire
FIQ Questionnaire was developed in 1991 as a specific measuring instrument for assessing the health status of patients with fibromyalgia. The validation of this adaptation and the evaluation of its psychometric properties were carried out by Perrot in 2002.
self-administered, exploring ten dimensions of the impact of pathology on quality of life.
Scale from 0 to 10, a high figure corresponding to a greater disadvantage or handicap. The analysis of the evolution of the FIQ over time, spontaneously or under treatment, is therefore dimension by dimension, in order to maintain a clinical informative value, as well as by an aggregate score ( corresponding to the algebraic sum of the dimensions evaluated, compared to 100 units). A weighting of the aggregate score is expected when the patient can not assess impact on professional activity.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Nov 2018
- Primary completion30 Jun 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640806
- Sponsor's protocol ID
- 2017-57
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2018
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ranque S, Laurin J, Linguraru MG, Jiang Z, Loundou A, Boyer L, Guieu R, Boucraut J, Sault C, Simon J, Barthelemy F, Donnet A, Guedj E. Efficacy and mechanism of supervised adapted physical activity on quality of life for patients with fibromyalgia: single-center, prospective, randomised clinical and neuroimaging study. Sci Rep. 2026 Feb 3;16(1):5398. doi: 10.1038/s41598-025-33433-5.
PubMed 41634061
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QOL Efficacy of Adapted Physical Activity for Patients With Fibromyalgia : Single-center, Prospective, Randomized With Biological and Cerebral Evaluation
- ClinicalTrials.gov ID
- NCT03640806
- Acronym / sponsor ID
- 2017-57
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
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".
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHYSICAL ACTIVITY | Experimental | Other: PHYSICAL ACTIVITYStandard support for 12 months (HAS 2010, EULAR 2016) 3 fibromyactiv workshops per week during the first 6 months, or 72 sessions. Each workshop lasts 2 hours of physical activity. |
| CONTROL | No intervention | –Standard care for 12 months (HAS 2010, EULAR 2016) with Pain Consultation every 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or male subject, 18 years of age or older, not pregnant, not breastfeeding, not deprived of liberty;
- Subject with fibromyalgia meeting the criteria of the American College of Rheumatology (ACR)
- Subject managed by the Center for Assessment and Pain Management of CHU Timone or addressed to it in consultation / day hospital;
- Subject free from any general illness or serious psychiatric disorders, and any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology of the central nervous system, determined during the interrogation;
- Subject not having a history of alcoholism or drug addiction,
Key exclusion criteria (5 listed)
- Major subject under legal protection or unable to express their consent: L1121-8 of the CSP
- Subject presenting a contraindication to the practice of physical activity, to scintigraphic scanning by PET,
- Subject deprived of liberty following a judicial or administrative decision
- Subject with psychiatric illness or Personality Disorder making group work difficult
- Subject refusing to participate in the study or not signing the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHYSICAL ACTIVITY3 fibromyactiv workshops per week during the first 6 months, or 72 sessions. Each workshop lasts 2 hours of physical activity. | Other | PHYSICAL ACTIVITY |
Primary outcome
The Fibromyalgia Impact Questionnaire
Time frame: 1 hour
FIQ Questionnaire was developed in 1991 as a specific measuring instrument for assessing the health status of patients with fibromyalgia. The validation of this adaptation and the evaluation of its psychometric properties were carried out by Perrot in 2002. self-administered, exploring ten dimensions of the impact of pathology on quality of life. Scale from 0 to 10, a high figure corresponding to a greater disadvantage or handicap. The analysis of the evolution of the FIQ over time, spontaneously or under treatment, is therefore dimension by dimension, in order to maintain a clinical informative value, as well as by an aggregate score ( corresponding to the algebraic sum of the dimensions evaluated, compared to 100 units). A weighting of the aggregate score is expected when the patient can not assess impact on professional activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Derived from this study: PubMed 41634061Ranque S, Laurin J, Linguraru MG, Jiang Z, Loundou A, Boyer L, Guieu R, Boucraut J, Sault C, Simon J, Barthelemy F, Donnet A, Guedj E. Efficacy and mechanism of supervised adapted physical activity on quality of life for patients with fibromyalgia: single-center, prospective, randomised clinical and neuroimaging study. Sci Rep. 2026 Feb 3;16(1):5398. doi: 10.1038/s41598-025-33433-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHYSICAL ACTIVITY in people with Fibromyalgia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fibromyalgia Impact Questionnaire (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.