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Trial record 68 of 285 for:    impact | "Fibromyalgia"

Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV Study. (FIMOUV)

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ClinicalTrials.gov Identifier: NCT03736733
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.


Condition or disease Intervention/treatment Phase
Fibromyalgia Physical Activity Other: physical activity program Other: Advice and recommendations of physical activity at home Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fibromyalgia patients with physical activity program
Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.
Other: physical activity program
Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.

fibromyalgia patients with physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Other: Advice and recommendations of physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).




Primary Outcome Measures :
  1. Assessment of the impact of a 3-month program [ Time Frame: at 3 months ]
    Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).


Secondary Outcome Measures :
  1. fatigue [ Time Frame: at 3 months ]

    assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7.

    Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5


  2. Quality of sleep [ Time Frame: at 3 months ]

    assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score.

    The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3.

    In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.


  3. Anxiety and Depression [ Time Frame: at 3 months ]
    assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.

  4. pain catastrophizing [ Time Frame: at 3 months ]
    assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time

  5. pain evaluation [ Time Frame: at 3 months ]
    assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

  6. muscle power [ Time Frame: at 3 months ]
    evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

  7. muscular endurance [ Time Frame: at 3 months ]
    evaluated by dynamometry on a stress platform (arms and legs).

  8. gas exchange measurement [ Time Frame: at 3 months ]
    evaluated during a stress test

  9. quantification of physical activity in meter-h/week [ Time Frame: at 3 months ]
    evaluated by the APAQ : Adult Physical Activity Questionnaire

  10. sedentary times in hours/day [ Time Frame: at 3 months ]
    evaluated by the APAQ : Adult Physical Activity Questionnaire

  11. daily energy expenditure [ Time Frame: at 3 months ]
    evaluated by actimetry

  12. time of physical activity [ Time Frame: at 3 months ]
    evaluated by actimetry

  13. physical inactivity [ Time Frame: at 3 months ]
    evaluated by actimetry

  14. patient adherence [ Time Frame: at 3 and 6 months ]
    number of sessions performed

  15. Direct medical costs [ Time Frame: at 3 and 6 months ]
    consultations, examinations, hospitalizations in euros

  16. Direct non-medical costs [ Time Frame: at 3 and 6 months ]
    transport

  17. Cost of lost productivity [ Time Frame: at 3 and 6 months ]
    time not worked



Information from the National Library of Medicine

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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 lived in t Loire (42) or Haute-Loire (43)
  • Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
  • French writing and speaking
  • Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
  • Signature of informed consent

Exclusion Criteria:

  • Cardiac or respiratory diseases that contraindicate the practice of physical activity
  • Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
  • Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

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): NCT03736733


Contacts
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Contact: David HUPIN 0477828413 ext +33 David.Hupin@chu-st-etienne.fr

Locations
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France
Chu Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: HUPIN David       David.Hupin@chu-st-etienne.fr   
Sub-Investigator: FEASSON Léonard, MD         
Sub-Investigator: ROCHE Frédéric, MD         
Sub-Investigator: CALMELS Paul, MD         
Sub-Investigator: CREAC'H Christelle, MD         
Sub-Investigator: CATHEBRAS Pascal, MD         
Sub-Investigator: FAYOLLE-MINON Isabelle, MD         
Sub-Investigator: LUCHT Frédéric, MD         
Sub-Investigator: THOMAS Thierry, MD         
Sub-Investigator: MAROTTE Hubert, MD         
Sub-Investigator: CAMDESSANCHE Jean Philippe, MD         
Sub-Investigator: MASSOUBRE Catherine, MD         
Sub-Investigator: FONTANA Luc, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: David HUPIN CHU de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03736733     History of Changes
Other Study ID Numbers: 18CH051
2018-A01597-48 ( Other Identifier: ANSM )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Centre Hospitalier Universitaire de Saint Etienne:
sedentary time

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases