Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. (FIMOUV 1)
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Saint Etienne, Francia, 42055
- CHU Saint Etienne
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: pacientes con fibromialgia con programa de actividad física
Dos sesiones de ejercicio semanales en el hospital universitario de St-Etienne durante 1 mes y luego relevos al aire libre en una asociación o club deportivo certificado "Sports Health" en Loire (42) o Haute-Loire (43) durante 2 meses.
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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.
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Otro: pacientes con fibromialgia con actividad física en casa
Consejos y recomendaciones de actividad física en casa (= práctica clínica actual, de 1 a 3 sesiones por semana en autonomía).
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Consejos y recomendaciones de actividad física en casa (= práctica clínica actual, de 1 a 3 sesiones por semana en autonomía).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessment of the impact of a 3-month program
Periodo de tiempo: at 3 months
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Health status assessed by the PGIC = Patient Global Impression of Change.
interpretation : 0= no change, 7= clear improvement, 5= better).
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at 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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fatigue
Periodo de tiempo: at 3 months
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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 |
at 3 months
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Quality of sleep
Periodo de tiempo: at 3 months
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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. |
at 3 months
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Anxiety and Depression
Periodo de tiempo: at 3 months
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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.
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at 3 months
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pain catastrophizing
Periodo de tiempo: at 3 months
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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
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at 3 months
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pain evaluation
Periodo de tiempo: at 3 months
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assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
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at 3 months
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muscle power
Periodo de tiempo: at 3 months
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evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
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at 3 months
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muscular endurance
Periodo de tiempo: at 3 months
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evaluated by dynamometry on a stress platform (arms and legs).
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at 3 months
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gas exchange measurement
Periodo de tiempo: at 3 months
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evaluated during a stress test
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at 3 months
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quantification of physical activity in meter-h/week
Periodo de tiempo: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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sedentary times in hours/day
Periodo de tiempo: at 3 months
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evaluated by the APAQ : Adult Physical Activity Questionnaire
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at 3 months
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daily energy expenditure
Periodo de tiempo: at 3 months
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evaluated by actimetry
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at 3 months
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time of physical activity
Periodo de tiempo: at 3 months
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evaluated by actimetry
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at 3 months
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physical inactivity
Periodo de tiempo: at 3 months
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evaluated by actimetry
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at 3 months
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patient adherence
Periodo de tiempo: at 3, 6 and 12 months
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number of sessions performed
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at 3, 6 and 12 months
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Direct medical costs
Periodo de tiempo: at 3, 6 and 12 months
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consultations, examinations, hospitalizations in euros
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at 3, 6 and 12 months
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Direct non-medical costs
Periodo de tiempo: at 3, 6 and 12 months
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transport
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at 3, 6 and 12 months
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Cost of lost productivity
Periodo de tiempo: at 3, 6 and 12 months
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time not worked
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at 3, 6 and 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David HUPIN, MD, Chu de Saint Etienne
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 18CH051
- 2018-A01597-48 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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