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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) (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
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 24, 2020
    Last Updated
    March 19, 2020
    Sponsor
    University Hospital, Grenoble
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    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

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    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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