FibromyalgiaFibrAPSpéNCT03895086
Fibromyalgia and Specific Physical Activity
A study testing Specific Physical Activity and Classic Physical Activity in people with Fibromyalgia, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
Fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain. Usual treatment consists of multimodal care including physical activity. This dosage should be adapted to the patient's health needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Specific Physical Activity and Classic Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2020to 14 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Major patient
- Patient whose FIQ ≤ 59/100
- Patient who can be followed for 12 months in the CETD
- Patient able to follow the adaptated physical activities proposed by "Siel Bleu", on the physical and organizational level
- Patient with a smartphone and/or a computer (mac/pc) with an internet connection allowing the use of a tracking application linked to the activity tracker
- Patient with the ability to understand protocol and consenting to participate in this study
- Patient benefiting from a social cover
Who cannot join
- Patient participating in an interventional trial within 3 months of enrollment
- Pregnant or lactating woman, or having the possibility to procreate without effective contraception
- Patient minor, under guardianship, curators or deprived of liberty
- Patient unable to follow the protocol, according to the judgment of the investigator, or refusing to use of digital applications
- Patient with contraindications to physical activity
- Patient having already followed the physical activities proposed by 'Siel Bleu"
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
Centre Hospitalier Universitaire
Nantes
About this study
Fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain.
Usual treatment consists of multimodal care including physical activity. This dosage should be adapted to the patient's health needs. Currently recommended physical exercise is aerobic work associated with muscle reinforcement, without evidence of superiority of the efficacy of one over the other. Recommended dosage for aerobic exercises is 20 minutes (or twice 10 minutes), two to three times a week (70 - 80% of Theoretical Maximum Heart Rate).
Read more
At the Vendee Departmental Hospital Center (CHD), adapted physical activity is proposed to fibromyalgia patientsby the associative group "Siel Bleu". This physical activity, performed with patients suffering from different pathologies, is non specific for fibromyalgia context.
In parallel, a preliminary study showed the interest of a lifestyle coaching for fibromyalgia patients, performed by physiotherapists, nurses and coaches specifically trainede.
Another possibility seems to be personalized coaching with a physical activity adapted to the physical and organizational constraints of the patient, and specific to pathology. This solution would make it possible to adapt to the patient's choice of physical activities, to ensure a better adaptation to their physical and organizational constraints as well as a better individualized follow-up.
- Conditions
- Fibromyalgia
- Being tested
- Specific Physical Activity, Classic 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.
Specific Physical ActivityOther
An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)
Classic Physical ActivityBehavioural
One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
| Study group | Role | What they receive |
|---|---|---|
| Specific Physical Activity | Experimental | Specific patient care in telephone coaching of fibromyalgia patients. Receives: Other: Specific Physical Activity |
| Classic Physical Activity | Other | Classic patient care in common group of multipathological patients. Receives: Behavioral: Classic Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the Interest of a Specific Physical Activity Program on Patients' Quality of Life
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) score (questionnaire of specific quality of life in the management of fibromyalgia patients) between the beginning of care (J0) and six months (M6).
The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start13 Feb 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Why it stopped: The study was stopped prematurely due to a lack of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas RULLEAU, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895086
- Sponsor's protocol ID
- CHD110-18
- Acronym
- FibrAPSpé
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2019
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rulleau T, Planche L, Etcheverrigaray F, Dorion A, Kacki N, Miot M, Liaigre A, Ganem Y, Schmidt A, Taddei F, Acapo S, Nizard J, Pluchon YM. Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial. Trials. 2020 Sep 17;21(1):800. doi: 10.1186/s13063-020-04730-3.
PubMed 32943085
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia and Specific Physical Activity
- ClinicalTrials.gov ID
- NCT03895086
- Acronym / sponsor ID
- FibrAPSpé / CHD110-18
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to a lack of participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain.
Usual treatment consists of multimodal care including physical activity. This dosage should be adapted to the patient's health needs. Currently recommended physical exercise is aerobic work associated with muscle reinforcement, without evidence of superiority of the efficacy of one over the other. Recommended dosage for aerobic exercises is 20 minutes (or twice 10 minutes), two to three times a week (70 - 80% of Theoretical Maximum Heart Rate).
At the Vendee Departmental Hospital Center (CHD), adapted physical activity is proposed to fibromyalgia patientsby the associative group "Siel Bleu". This physical activity, performed with patients suffering from different pathologies, is non specific for fibromyalgia context.
In parallel, a preliminary study showed the interest of a lifestyle coaching for fibromyalgia patients, performed by physiotherapists, nurses and coaches specifically trainede.
Another possibility seems to be personalized coaching with a physical activity adapted to the physical and organizational constraints of the patient, and specific to pathology. This solution would make it possible to adapt to the patient's choice of physical activities, to ensure a better adaptation to their physical and organizational constraints as well as a better individualized follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Physical Activity | Experimental | Other: Specific Physical ActivitySpecific patient care in telephone coaching of fibromyalgia patients. |
| Classic Physical Activity | Other | Behavioral: Classic Physical ActivityClassic patient care in common group of multipathological patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major patient
- Patient whose FIQ ≤ 59/100
- Patient who can be followed for 12 months in the CETD
- Patient able to follow the adaptated physical activities proposed by "Siel Bleu", on the physical and organizational level
- Patient with a smartphone and/or a computer (mac/pc) with an internet connection allowing the use of a tracking application linked to the activity tracker
Key exclusion criteria (6 listed)
- Patient participating in an interventional trial within 3 months of enrollment
- Pregnant or lactating woman, or having the possibility to procreate without effective contraception
- Patient minor, under guardianship, curators or deprived of liberty
- Patient unable to follow the protocol, according to the judgment of the investigator, or refusing to use of digital applications
- Patient with contraindications to physical activity
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 |
|---|---|---|
| Specific Physical ActivityAn individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each) | Other | Specific Physical Activity |
| Classic Physical ActivityOne session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association | Behavioural | Classic Physical Activity |
Primary outcome
Compare the Interest of a Specific Physical Activity Program on Patients' Quality of Life
Time frame: 6 months after randomization
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) score (questionnaire of specific quality of life in the management of fibromyalgia patients) between the beginning of care (J0) and six months (M6). The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32943085Rulleau T, Planche L, Etcheverrigaray F, Dorion A, Kacki N, Miot M, Liaigre A, Ganem Y, Schmidt A, Taddei F, Acapo S, Nizard J, Pluchon YM. Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial. Trials. 2020 Sep 17;21(1):800. doi: 10.1186/s13063-020-04730-3.
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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.
Thomas RULLEAU principal investigator
CHD Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Physical Activity and Classic Physical Activity in people with Fibromyalgia, run by Centre Hospitalier Departemental Vendee at 2 sites 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Compare the Interest of a Specific Physical Activity Program on Patients' Quality of Life (time frame: 6 months after randomization). 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 NCT03895086, 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 23 Apr 2026.