- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03597802
Exercise at Workplace for Manual Material Handling Workers
Effectiveness of Exercise at Workplace for Manual Material Handling Workers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objective: This study aim to evaluate the effectiveness of exercise at workplace for control and prevention nonspecific low back pain. Methods: This is a randomized control trial study by cluster with three parallel groups. The context of this study is a motorcycle parts company importer localized in several states (Piaui, Ceará e Maranhão). The company has 575 workers, being 240 manual material handling. All are men over 18 years old that perform goods shipment (each work develop one this tasks - stock, separation, conference and packaging).
The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form. The exclusion criterial were sick leave. The workers will be included with low back pain or no low back pain (at baseline). All will be interviewed to obtain: weight, height, BMI, age, marital status, educational level, and actual function (stock, separation, conference and packaging sick leave (the last 12 months), musculoskeletal complains, medications, complementary exams, surgery and or fractures. Participants will be randomized in three groups: (1) control group - will be receive orientation about manual material handling, postural and low back care (lecture and guidance). The training will be instructions according Ergonomics standard (NR17) about transportation and load handling and exercise in workout. (2) Intervention group 1 - will receive the same instruction of the control group, and will perform exercise at workplace four times per week, during 15 minutes; (3) Intervention group 2 - will be receive the same instruction of the control group, and will perform exercise at workplace three times per week, during 15 minutes. Outcomes: The outcome measure will be verified in three moments at baseline, six and eleven months of the intervention. The primary outcome is pain, electromyography. Secondary outcome is palmar dynamometer, BMI, exercise workout.
Expected Results: The manual material handling workers will be better after intervention by exercise at workplace. The effectiveness of exercise for low back pain and no low back pain groups will be contribute to change the behavior in occupational context.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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São Paulo, Brasil, 12942770
- Reclutamiento
- Rosimeire Simprini Padula
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Contacto:
- Rosimeire S Padula
- Número de teléfono: +55 11999166215
- Correo electrónico: rosipadula@gmail.com
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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:
- The inclusion criterial are workers that perform manual material handling for at least six months and signing informed consent form.
Exclusion Criteria:
- The exclusion criterial were sick leave
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control Group
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance).
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Comparador activo: Intervention group 1
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance), and will perform exercise at workplace three times per week, during 15 minutes
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The exercise at workplace will be occur during the workday during the rest breaks.
The exercises perform are stretching, and using load.
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Comparador activo: Intervention group 2
The workers will be receive orientation about manual material handling, postural and low back care (lecture and guidance) and and will perform exercise at workplace four times per week, during 15 minutes.
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The exercise at workplace will be occur during the workday during the rest breaks.
The exercises perform are stretching, and using load.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Pain Intensity at 6 months
Periodo de tiempo: At baseline and after six months
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Likert scale (0-10 points)
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At baseline and after six months
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Change from electromyographic signal at 6 months
Periodo de tiempo: At baseline and after six months
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RMS (root mean square error) signal and peak signal by Electromyographic (EMG)
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At baseline and after six months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from palmar grip strength at 6 months
Periodo de tiempo: At baseline and six months
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Three measure palmar grip strength to use the mean by dynamometer
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At baseline and six months
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Change from body mass index at 6 months
Periodo de tiempo: At baseline and after six months
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The body mass index will be calculated on height divided by square weight
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At baseline and after six months
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Change of behavior to exercise
Periodo de tiempo: At baseline and after six months
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Practice of exercise (practice - yes or no; number of times per week)
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At baseline and after six months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 2.372.435
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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