- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02552680
Preventive Program for Work-Related Musculoskeletal Disorders
Influence of a Preventive Program (Educational and Gymnastics) for Work-Related Musculoskeletal Disorders in Surgeons
Introduction: Work-Related Musculoskeletal Disorders (WMSDs) are characterized by inflammation of muscles, tendons, fascia and nerves of upper limbs, shoulder girdle and neck. Its incidence is increasing and there is evidence of its association with the pace of work. As WMSDs, another major public health problem is back pain, which also negatively influence the quality of life of patients. These diseases affect many workers, among them, workers in the health area, including surgeons. Studies show that many surgeons are suffering from fatigue and musculoskeletal pain after undergoing surgery, especially laparoscopy. Regarding the quality of life of doctors, a study indicates that surgeons have commitment of domains "Vitality" and "Pain". For these reasons it is important to develop strategies for prevention of occupational risks (WMSDs) in this class of workers.
Objectives: To evaluate the influence of a Preventive Program (educational and gymnastics) for prevention of WMSDs, in the quality of life, in limitation of the work, in intensity and frequency of musculoskeletal pain in surgeons of the Hospital de Clínicas de Porto Alegre. There will also be evaluated the effects of the program on muscular strength and flexibility of medics participating in the Preventive Program.
Methodology: Randomized clinical trial with a sample of 54 surgeons, divided into two groups: A ("Intervention": will participate in eight meetings consisting of exercise and guidelines on care and prevention of WMSDs in activities of daily living, especially those relating work activities) and B ("Control": will receive a manual-brochure - containing information about general health). Participants will sign a Letter of Consent.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Clinical Trial Study with 54 surgeons allocated in two groups: A and B. They received two protocols in accordance with the groups they have been allocated.
Group A: participated in eight meetings supervised by physical education professionals, with 15 minutes duration, individually administered, twice a week, during the surgeons working hours, at times and places combined with them. The meetings were composed of endurance exercise, mobility and muscle stretching. They were also given guidance on care and prevention of Work-Related Musculoskeletal Disorders in activities fo daily life, especially those related to work activities.
Group B: received a manual (brochure ) containing information on general health care, especially designed for this study. With food guide, sleep, physical activity and smoking.
Were measured the quality of life, muscle force, muscle stretching and pain. The dates were collected at the beginning of the procedures, 4 weeks after the protocols and 26 after the protocols.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- surgeons (teachers, contractors and medical residents)
- of the Hospital de Clínicas de Porto Alegre
- members of General Surgery teams, Digestive Surgery , Plastic Surgery and Coloproctology
- of both sexes
Exclusion Criteria:
- individuals who did not agree to participate in the study
- those who were not present at the time of the study (regardless of reason)
- those who had some more serious illness that prevented the achievement of study protocols
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exercise + guideline
Participants will participate in eight meetings consisting of exercise and guidelines on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.
|
Physical Exercise
Guideline on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.
|
|
Comparador activo: brochure
Participants will receive a manual-brochure - containing information about general health.
|
Manual/brochure containing information about general health
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of life
Periodo de tiempo: 26 weeks after the interventions
|
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36).
Unit of measure: Scale of Quality of life.
|
26 weeks after the interventions
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle strength - Grip and Pinch Strength
Periodo de tiempo: 4 weeks and 26 weeks after the interventions
|
Evaluated by hand grip dynamometer and pinch grip dynamometer.
Unit of measure: kilogram force (kgf) (both evaluations).
|
4 weeks and 26 weeks after the interventions
|
|
Muscle flexibility
Periodo de tiempo: 4 weeks and 26 weeks after the interventions
|
Evaluated by "Banco de Wells".
Unit of measure: centimeters (cm)
|
4 weeks and 26 weeks after the interventions
|
|
Musculoskeletal intensity of pain
Periodo de tiempo: 4 weeks and 26 weeks after the interventions
|
Evaluated by Questionnaire.
Unit of measure: Scale of pain.
|
4 weeks and 26 weeks after the interventions
|
|
Quality of life - after 4 weeks
Periodo de tiempo: 4 weeks after the interventions
|
Quality of life evaluated by the Short-Form Survey Questionnaire (SF-36).
Unit of measure: Scale of Quality of life.
|
4 weeks after the interventions
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Antônio C dos Santos, Doctorate, Federal University of Rio Grande do Sul
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- GPPG100432
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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