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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

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Adapted Physical Activity Therapeutic Education Electric Bike Other: Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
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
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.
Estimated Study Start Date : March 15, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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).

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).
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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)

  6. 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

  7. 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)

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318054


Contacts
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Contact: Caroline Maindet, MD +33476765213 Cmaindetdominici@chu-grenoble.fr
Contact: Gilliane Lalami +33476766729 GLalami@chu-grenoble.fr

Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Caroline Maindet, MD University Hospital, Grenoble
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04318054    
Other Study ID Numbers: 38RC19.128
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
fibromyalgia
chronic pain
adapted physical activity
therapeutic education
electric bike
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases