FibromyalgiaFibrovelisNCT04318054
Medical Benefit Evaluation of Ambulatory Activity Combining Rehabilitation and Therapeutic Education, Using an Intelligent Electric Bike for the Health, for the Effort Rehabilitation and the Quality of Life Improvement for Patients Suffering of Moderate Fibromyalgia (FIBROVELIS)
A study testing Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health. in people with Fibromyalgia and Chronic Pain, run by University Hospital, Grenoble.
Trial summary
The aim of this study is to decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education workshop. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pain, Adapted Physical Activity
- What is being tested?
- Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2020to 1 Feb 2023
- 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 aged 18 and over
- Patient available for a following of 18 months
- Patient available for go to sessions of Intelligent Electric Bike for the Health, 2 half-day by week during 8 weeks in the 2 months following the randomization.
- confirmed fibromyalgia according to the criteria of the American College of Rhumatology 2010 since at least one year with a stable treatment since at least 3 months.
- Patients with a score of 39 ≤ FIQ < 59 (moderate fibromyalgia impact)
- Patient in capacity to pedal on a bike outside.
Show all 10Show fewer
- Patient who haven't contraindications at the practice of an moderate physical activity or bike (acute coronary pathology less than 2 years, locomotor problems of the spine or lower limbs incompatible with the bike practice).
- Weight lower than 125 kg (maximal load for the Intelligent Electric Bike for the Health).
- Patient having signed the written consent after appropriate information and delivery of the information note.
- Patient affiliated at the social security or beneficiary of such a scheme
Who cannot join
- Substantial variation of the therapeutic care in the 3 months previous the inclusion (change of drug class, beginning of physical reconditioning in an unit of follow-up and rehabilitation care, or a cognitive-behavioral technique)
- Patient with treatement which can deteriorate the attention
- Patient suffering of a serious chronic desease destabilized (acute coronary pathology and/ or CVA in the last 6 months, serious asthma, serious heart failure, respiratory, lung or kidney failure, progressive inflammatory rheumatic disease…)
- Women under contraception and with a pregnancy project
- Patient already includes in a research protocol involving the human person
- Protected persons
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Medical Benefit Evaluation of Ambulatory Activity Combining Rehabilitation and Therapeutic Education, Using an Intelligent Electric Bike for the Health, for the Effort Rehabilitation and the Quality of Life Improvement for Patients Suffering of Moderate Fibromyalgia.
The aim of this study is to decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education workshop.
Read the detailed description
Fibromyalgia is chronic pain syndrome expressed as fluctuacting musculotendinous or articular pain and chronic tiredness. Among the non-pharmacological treatments, apart the "psychological" accompanying, the EULAR (European League Against Reumatism) recommends the physical activity in first intention. Thus, physical reconditioning has an important place in fibromyalgia. Aerobic conditioning or reconditioning programs for effort induce for some patients a benefit on quality of life, tiredness and pain. In France, these programmes are mostly carried out in "follow-up and rehabilitation" type care structures.
Outdoor exercise re-training with the Intelligent Electric Bike for Health combined with therapeutic education sessions are proposed in the study. These activities, adapted to each group and patient, can best achieve the objective in an ambulatory format closer to the patient's daily life.
- Conditions
- Fibromyalgia, Chronic Pain, Adapted Physical Activity, Therapeutic Education, Electric Bike
- Being tested
- Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
- Keywords
- fibromyalgia, chronic pain, adapted physical activity, therapeutic education, electric bike
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.Other
fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention group | Experimental | fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, in the 2 months following the randomization, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). Receives: Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health. |
| Deferred intervention group | Other | Deferred intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, one year after the inclusion, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). Receives: Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education.
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) at 6 months compared to baseline.
Measured: 6 months
Secondary outcomes (20)
Evaluation of the kinetic of the evolution at the inclusion, at short-term (3 months), at medium-term (6 months) and at long-term (12 months) of the FIQ (Fibromyalgia Impact Questionnaire).
Evolution of the FIQ score between the inclusion, 3 months, 6 months and 12 months.
Measured: 3, 6 and 12 months
Compare the percentage of patients who achieve an FIQ<39 at 6 months (threshold defining an fibromyalgia impact weak).
Percentage comparison of the patients who achieve an FIQ<39 at 6 months.
Measured: 6 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the hetero-evaluation by a doctor of the global health state.
Measured: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the self-assessment by the patient (Patient global assessment / Patient Global Impression of Change Scale).
Measured: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Global Physical Activity Questionnaire (GPAQ)
Measured: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Pain VAS
Measured: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Pichot score (tiredness)
Measured: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Questionnaire PSQI (Pittsburgh Sleep Quality Index).
Measured: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the TSK (Tampa Scale for Kinesiophobia).
Measured: 3, 6 and 12 months
Improve the global quality of life
Improvement of the questionnaire EQD-3L between the inclusion, 3 months, 6 months and 12 months.
Measured: 3, 6 and 12 months
Improve self-esteem
Improvement of the score de Rosenberg between the inclusion, 3 months, 6 months and 12 months.
Measured: 3, 6 and 12 months
Improve the mood
Improvement of the questionnaire HADS between the inclusion, 3 months, 6 months and 12 months.
Measured: 3, 6 and 12 months
Diminuate the health care consumption of the subjects at 3, 6 and 12 months compared to baseline.
Decrease of the pharmacological consumption (by therapeutic class : analgesic, antidepressant, antiepileptic, other), medical and paramedical consultation, hospitalization, professional absenteeism, resort to complementary medicine between the inclusion, 3 months, 6 months and 12 months.
Measured: 3, 6 and 12 months
Improve the perception of the impact of the disease in the relations with close relations
Evaluation by a close relation of the disease evolution and the relational impact via an VAS between the inclusion, 3 months, 6 months and 12 months.
Measured: 3, 6 and 12 months
Study the impact of the Fibrovelis program on the evolution of the muscular parameter.
Change from baseline of the muscular parameters record by the Intelligent Electric Bike for the Health during an standardized stress test repeted at the end of after the intervention program.
Measured: 3 months (second to last trip of the intervention program).
Study the impact of the Fibrovelis program on the evolution of cardio-respiratory physiological efficiency parameter.
Change from baseline of the cardio-respiratory physiological parameters record by the Intelligent Electric Bike for the Health during an standardized stress test repeted at the end of after the intervention program.
Measured: 3 months (second to last trip of the intervention program).
Evaluate the remanence of the long-term effect for the immediate intervention group
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) and principal secondary outcomes at 18 months compared to Baseline for the immediate intervention group.
Measured: 18 months
Evaluate the effect size of the intervention between 12 and 18 months for the diferred intervention group.
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) and principal secondary outcomes at 18 months compared to 12 months for the diferred intervention group.
Measured: 12 and 18 months
In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the muscular power parameters.
Change from Baseline of the muscular power data.
Measured: 3 months
In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the cardio respiratory parameters.
Change from Baseline of the cardio respiratory physiological data.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start15 Mar 2020 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Immediate intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, in the 2 months following the randomization, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). Deferred intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, one year after the inclusion, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Maindet, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318054
- Sponsor's protocol ID
- 38RC19.128
- Acronym
- Fibrovelis
- Status last verified
- Mar 2020
- First submitted
- 24 Jan 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wolfe F. Fibromyalgia: the clinical syndrome. Rheum Dis Clin North Am. 1989 Feb;15(1):1-18.
PubMed 2644671Cazzola M, Atzeni F, Salaffi F, Stisi S, Cassisi G, Sarzi-Puttini P. Which kind of exercise is best in fibromyalgia therapeutic programmes? A practical review. Clin Exp Rheumatol. 2010 Nov-Dec;28(6 Suppl 63):S117-24. Epub 2010 Dec 22.
PubMed 21176431Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.
PubMed 27299435Gojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.
PubMed 22005715
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Benefit Evaluation of Ambulatory Activity Combining Rehabilitation and Therapeutic Education, Using an Intelligent Electric Bike for the Health, for the Effort Rehabilitation and the Quality of Life Improvement for Patients Suffering of Moderate Fibromyalgia.
- ClinicalTrials.gov ID
- NCT04318054
- Acronym / sponsor ID
- Fibrovelis / 38RC19.128
- Conditions
- Fibromyalgia, Chronic Pain, Adapted Physical Activity, Therapeutic Education, Electric Bike
- Keywords
- fibromyalgia, chronic pain, adapted physical activity, therapeutic education, electric bike
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 23 Mar 2020 (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.
The aim of this study is to decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education workshop.
Detailed description
Fibromyalgia is chronic pain syndrome expressed as fluctuacting musculotendinous or articular pain and chronic tiredness. Among the non-pharmacological treatments, apart the "psychological" accompanying, the EULAR (European League Against Reumatism) recommends the physical activity in first intention. Thus, physical reconditioning has an important place in fibromyalgia. Aerobic conditioning or reconditioning programs for effort induce for some patients a benefit on quality of life, tiredness and pain. In France, these programmes are mostly carried out in "follow-up and rehabilitation" type care structures.
Outdoor exercise re-training with the Intelligent Electric Bike for Health combined with therapeutic education sessions are proposed in the study. These activities, adapted to each group and patient, can best achieve the objective in an ambulatory format closer to the patient's daily life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Immediate intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, in the 2 months following the randomization, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). Deferred intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, one year after the inclusion, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention group | Experimental | Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, in the 2 months following the randomization, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). |
| Deferred intervention group | Other | Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.Deferred intervention group : fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice, one year after the inclusion, an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient aged 18 and over
- Patient available for a following of 18 months
- Patient available for go to sessions of Intelligent Electric Bike for the Health, 2 half-day by week during 8 weeks in the 2 months following the randomization.
- confirmed fibromyalgia according to the criteria of the American College of Rhumatology 2010 since at least one year with a stable treatment since at least 3 months.
- Patients with a score of 39 ≤ FIQ < 59 (moderate fibromyalgia impact)
Key exclusion criteria (6 listed)
- Substantial variation of the therapeutic care in the 3 months previous the inclusion (change of drug class, beginning of physical reconditioning in an unit of follow-up and rehabilitation care, or a cognitive-behavioral technique)
- Patient with treatement which can deteriorate the attention
- Patient suffering of a serious chronic desease destabilized (acute coronary pathology and/ or CVA in the last 6 months, serious asthma, serious heart failure, respiratory, lung or kidney failure, progressive inflammatory rheumatic disease…)
- Women under contraception and with a pregnancy project
- Patient already includes in a research protocol involving the human person
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 |
|---|---|---|
| Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week). | Other | Deferred intervention group, Immediate intervention group |
Primary outcome
Decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education.
Time frame: 6 months
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) at 6 months compared to baseline.
20 secondary outcomes
Evaluation of the kinetic of the evolution at the inclusion, at short-term (3 months), at medium-term (6 months) and at long-term (12 months) of the FIQ (Fibromyalgia Impact Questionnaire).
Time frame: 3, 6 and 12 months
Compare the percentage of patients who achieve an FIQ<39 at 6 months (threshold defining an fibromyalgia impact weak).
Time frame: 6 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Time frame: 3, 6 and 12 months
Improve the global quality of life
Time frame: 3, 6 and 12 months
Improve self-esteem
Time frame: 3, 6 and 12 months
Improve the mood
Time frame: 3, 6 and 12 months
Diminuate the health care consumption of the subjects at 3, 6 and 12 months compared to baseline.
Time frame: 3, 6 and 12 months
Improve the perception of the impact of the disease in the relations with close relations
Time frame: 3, 6 and 12 months
Study the impact of the Fibrovelis program on the evolution of the muscular parameter.
Time frame: 3 months (second to last trip of the intervention program).
Study the impact of the Fibrovelis program on the evolution of cardio-respiratory physiological efficiency parameter.
Time frame: 3 months (second to last trip of the intervention program).
Evaluate the remanence of the long-term effect for the immediate intervention group
Time frame: 18 months
Evaluate the effect size of the intervention between 12 and 18 months for the diferred intervention group.
Time frame: 12 and 18 months
In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the muscular power parameters.
Time frame: 3 months
In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the cardio respiratory parameters.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Background: PubMed 2644671Wolfe F. Fibromyalgia: the clinical syndrome. Rheum Dis Clin North Am. 1989 Feb;15(1):1-18.
- Results publication: PubMed 21176431Cazzola M, Atzeni F, Salaffi F, Stisi S, Cassisi G, Sarzi-Puttini P. Which kind of exercise is best in fibromyalgia therapeutic programmes? A practical review. Clin Exp Rheumatol. 2010 Nov-Dec;28(6 Suppl 63):S117-24. Epub 2010 Dec 22.
- Results publication: PubMed 27299435Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.
- Results publication: PubMed 22005715Gojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.
- Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike. July 6, 2016 6:00 AM July 6,2016Link provided by the sponsor.
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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.
Caroline Maindet, MD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health. in people with Fibromyalgia and Chronic Pain, run by University Hospital, Grenoble.
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 10 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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Maindet, MD (+33476765213, Cmaindetdominici@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease the impact of the fibromyalgia on the daily quality of life of the patients suffering of moderate fibromyalgia at 6 months by the practice of an adapted physical activity coupled with therapeutic education. (time frame: 6 months). 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 NCT04318054, which also lists 4 linked publications.
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 Mar 2020.