FibromyalgiaFIMOUV 1NCT03736733
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.
A study testing physical activity program and Advice and recommendations of physical activity at home in people with Fibromyalgia and Physical Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Physical Activity
- What is being tested?
- physical activity program and Advice and recommendations of physical activity at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2018to 11 Jun 2021
- 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
- Patient lived in t Loire (42) or Haute-Loire (43)
- Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
- French writing and speaking
- Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
- Signature of informed consent
Who cannot join
- Cardiac or respiratory diseases that contraindicate the practice of physical activity
- Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
- Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.
The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.
Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.
- Conditions
- Fibromyalgia, Physical Activity
- Being tested
- physical activity program, Advice and recommendations of physical activity at home
- Keywords
- sedentary time
- Medical subject headings
- Fibromyalgia, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity programOther
Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.
Advice and recommendations of physical activity at homeOther
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
| Study group | Role | What they receive |
|---|---|---|
| fibromyalgia patients with physical activity program | Experimental | Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months. Receives: Other: physical activity program |
| fibromyalgia patients with physical activity at home | Other | Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy). Receives: Other: Advice and recommendations of physical activity at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the impact of a 3-month program
Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).
Measured: at 3 months
Secondary outcomes (17)
fatigue
assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7.
Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5
Measured: at 3 months
Quality of sleep
assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score.
The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3.
In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Measured: at 3 months
Anxiety and Depression
assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.
Measured: at 3 months
pain catastrophizing
assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time
Measured: at 3 months
pain evaluation
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
Measured: at 3 months
muscle power
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
Measured: at 3 months
muscular endurance
evaluated by dynamometry on a stress platform (arms and legs).
Measured: at 3 months
gas exchange measurement
evaluated during a stress test
Measured: at 3 months
quantification of physical activity in meter-h/week
evaluated by the APAQ : Adult Physical Activity Questionnaire
Measured: at 3 months
sedentary times in hours/day
evaluated by the APAQ : Adult Physical Activity Questionnaire
Measured: at 3 months
daily energy expenditure
evaluated by actimetry
Measured: at 3 months
time of physical activity
evaluated by actimetry
Measured: at 3 months
physical inactivity
evaluated by actimetry
Measured: at 3 months
patient adherence
number of sessions performed
Measured: at 3, 6 and 12 months
Direct medical costs
consultations, examinations, hospitalizations in euros
Measured: at 3, 6 and 12 months
Direct non-medical costs
transport
Measured: at 3, 6 and 12 months
Cost of lost productivity
time not worked
Measured: at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start15 Nov 2018
- Primary completion19 Dec 2019
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736733
- Sponsor's protocol ID
- 18CH051
- Other IDs
- 2018-A01597-48
- Acronym
- FIMOUV 1
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2018
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
- ClinicalTrials.gov ID
- NCT03736733
- Acronym / sponsor ID
- FIMOUV 1 / 18CH051
- Conditions
- Fibromyalgia, Physical Activity
- Keywords
- sedentary time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 9 Nov 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 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.
The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.
Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibromyalgia patients with physical activity program | Experimental | Other: physical activity programTwo weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months. |
| fibromyalgia patients with physical activity at home | Other | Other: Advice and recommendations of physical activity at homeAdvice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient lived in t Loire (42) or Haute-Loire (43)
- Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
- French writing and speaking
- Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
- Signature of informed consent
Key exclusion criteria (3 listed)
- Cardiac or respiratory diseases that contraindicate the practice of physical activity
- Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
- Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
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 activity programTwo weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months. | Other | fibromyalgia patients with physical activity program |
| Advice and recommendations of physical activity at homeAdvice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy). | Other | fibromyalgia patients with physical activity at home |
Primary outcome
Assessment of the impact of a 3-month program
Time frame: at 3 months
Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).
17 secondary outcomes
fatigue
Time frame: at 3 months
Quality of sleep
Time frame: at 3 months
Anxiety and Depression
Time frame: at 3 months
pain catastrophizing
Time frame: at 3 months
pain evaluation
Time frame: at 3 months
muscle power
Time frame: at 3 months
muscular endurance
Time frame: at 3 months
gas exchange measurement
Time frame: at 3 months
quantification of physical activity in meter-h/week
Time frame: at 3 months
sedentary times in hours/day
Time frame: at 3 months
daily energy expenditure
Time frame: at 3 months
time of physical activity
Time frame: at 3 months
physical inactivity
Time frame: at 3 months
patient adherence
Time frame: at 3, 6 and 12 months
Direct medical costs
Time frame: at 3, 6 and 12 months
Direct non-medical costs
Time frame: at 3, 6 and 12 months
Cost of lost productivity
Time frame: at 3, 6 and 12 months
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 29 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
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Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
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Daily Cognitive Failures and Medication Adherence in Fibromyalgia
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Not yet recruiting
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Not yet recruitingObservational study
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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.
David HUPIN, MD principal investigator
CHU de Saint Etienne
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 program and Advice and recommendations of physical activity at home in people with Fibromyalgia and Physical Activity, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 3 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 29 Sep 2022. 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?
Assessment of the impact of a 3-month program (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2022.