Back to resultsMedical 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) (Fibrovelis)
Primary Purpose
Fibromyalgia, Chronic Pain, Adapted Physical Activity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia focused on measuring fibromyalgia, chronic pain, adapted physical activity, therapeutic education, electric bike
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate intervention group
Deferred intervention group
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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)
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
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)
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).
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).
Improve the global quality of life
Improvement of the questionnaire EQD-3L between the inclusion, 3 months, 6 months and 12 months.
Improve self-esteem
Improvement of the score de Rosenberg between the inclusion, 3 months, 6 months and 12 months.
Improve the mood
Improvement of the questionnaire HADS between the inclusion, 3 months, 6 months 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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04318054
First Posted
January 24, 2020
Last Updated
March 19, 2020
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04318054
Brief 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 (FIBROVELIS)
Acronym
Fibrovelis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2020 (Anticipated)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain, Adapted Physical Activity, Therapeutic Education, Electric Bike
Keywords
fibromyalgia, chronic pain, adapted physical activity, therapeutic education, electric bike
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Deferred intervention group
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Description
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) at 6 months compared to baseline.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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).
Description
Evolution of the FIQ score between the inclusion, 3 months, 6 months and 12 months.
Time Frame
3, 6 and 12 months
Title
Compare the percentage of patients who achieve an FIQ<39 at 6 months (threshold defining an fibromyalgia impact weak).
Description
Percentage comparison of the patients who achieve an FIQ<39 at 6 months.
Time Frame
6 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
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.
Time Frame
3, 6 and 12 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
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).
Time Frame
3, 6 and 12 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Global Physical Activity Questionnaire (GPAQ)
Time Frame
3, 6 and 12 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Pain VAS
Time Frame
3, 6 and 12 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Pichot score (tiredness)
Time Frame
3, 6 and 12 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the Questionnaire PSQI (Pittsburgh Sleep Quality Index).
Time Frame
3, 6 and 12 months
Title
Evaluate in a global way the disease evolution according to the 4 axis of the EULAR (pain, tiredness, sleep quality, physical activity).
Description
Evolution of fibromyalgia between the inclusion, 3 months, 6 months and 12 months according to the TSK (Tampa Scale for Kinesiophobia).
Time Frame
3, 6 and 12 months
Title
Improve the global quality of life
Description
Improvement of the questionnaire EQD-3L between the inclusion, 3 months, 6 months and 12 months.
Time Frame
3, 6 and 12 months
Title
Improve self-esteem
Description
Improvement of the score de Rosenberg between the inclusion, 3 months, 6 months and 12 months.
Time Frame
3, 6 and 12 months
Title
Improve the mood
Description
Improvement of the questionnaire HADS between the inclusion, 3 months, 6 months and 12 months.
Time Frame
3, 6 and 12 months
Title
Diminuate the health care consumption of the subjects at 3, 6 and 12 months compared to baseline.
Description
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.
Time Frame
3, 6 and 12 months
Title
Improve the perception of the impact of the disease in the relations with close relations
Description
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.
Time Frame
3, 6 and 12 months
Title
Study the impact of the Fibrovelis program on the evolution of the muscular parameter.
Description
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.
Time Frame
3 months (second to last trip of the intervention program).
Title
Study the impact of the Fibrovelis program on the evolution of cardio-respiratory physiological efficiency parameter.
Description
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.
Time Frame
3 months (second to last trip of the intervention program).
Title
Evaluate the remanence of the long-term effect for the immediate intervention group
Description
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) and principal secondary outcomes at 18 months compared to Baseline for the immediate intervention group.
Time Frame
18 months
Title
Evaluate the effect size of the intervention between 12 and 18 months for the diferred intervention group.
Description
Evolution of the Fibromyalgia Impact Questionnaire (FIQ) and principal secondary outcomes at 18 months compared to 12 months for the diferred intervention group.
Time Frame
12 and 18 months
Title
In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the muscular power parameters.
Description
Change from Baseline of the muscular power data.
Time Frame
3 months
Title
In the 2 groups, describe and analyze the effort adaptation in a population suffering of moderate fibromyalgia according the cardio respiratory parameters.
Description
Change from Baseline of the cardio respiratory physiological data.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Maindet, MD
Phone
+33476765213
Email
Cmaindetdominici@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gilliane Lalami
Phone
+33476766729
Email
GLalami@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Maindet, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
2644671
Citation
Wolfe F. Fibromyalgia: the clinical syndrome. Rheum Dis Clin North Am. 1989 Feb;15(1):1-18.
Results Reference
background
PubMed Identifier
21176431
Citation
Cazzola 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 Reference
result
PubMed Identifier
27299435
Citation
Peterman 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 Reference
result
PubMed Identifier
22005715
Citation
Gojanovic 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.
Results Reference
result
Links:
URL
https://well.blogs.nytimes.com/2016/07/06/the-surprising-health-benefits-of-an-electric-bike-2/
Description
Gretchen Reynolds. The Surprising Health Benefits of an Electric Bike. July 6, 2016 6:00 AM July 6,2016
Learn more about this trial
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)
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