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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)

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ClinicalTrials.gov Identifier: NCT04318054
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE January 24, 2020
First Posted Date  ICMJE March 23, 2020
Last Update Posted Date March 23, 2020
Estimated Study Start Date  ICMJE March 15, 2020
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • 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 ]
    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). [ Time Frame: 6 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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). [ Time Frame: 3, 6 and 12 months ]
    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 [ Time Frame: 3, 6 and 12 months ]
    Improvement of the questionnaire EQD-3L between the inclusion, 3 months, 6 months and 12 months.
  • Improve self-esteem [ Time Frame: 3, 6 and 12 months ]
    Improvement of the score de Rosenberg between the inclusion, 3 months, 6 months and 12 months.
  • Improve the mood [ Time Frame: 3, 6 and 12 months ]
    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. [ Time Frame: 3, 6 and 12 months ]
    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 [ Time Frame: 3, 6 and 12 months ]
    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. [ Time Frame: 3 months (second to last trip of the intervention program). ]
    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. [ Time Frame: 3 months (second to last trip of the intervention program). ]
    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 [ Time Frame: 18 months ]
    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. [ Time Frame: 12 and 18 months ]
    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. [ Time Frame: 3 months ]
    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. [ Time Frame: 3 months ]
    Change from Baseline of the cardio respiratory physiological data.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Fibromyalgia
  • Chronic Pain
  • Adapted Physical Activity
  • Therapeutic Education
  • Electric Bike
Intervention  ICMJE 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 an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
Study Arms  ICMJE
  • Experimental: 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).
    Intervention: Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
  • Deferred intervention group
    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: Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2020)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date March 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Caroline Maindet, MD +33476765213 Cmaindetdominici@chu-grenoble.fr
Contact: Gilliane Lalami +33476766729 GLalami@chu-grenoble.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04318054
Other Study ID Numbers  ICMJE 38RC19.128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caroline Maindet, MD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP