- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05425693
Effects of Three Warm-up Interventions at the Workplace Among Vineyard Workers - a Protocol Study
Comparison of the Effects of Three Warm-up Interventions at the Workplace on Pain, Heart Rate, Work Performance and Physical Capacities Among Vineyard Workers - a Protocol Study
Background:
Physical activity programs at the workplace have shown positive results on physical capacities and pain for several years. Due to the duration of the training session, the need of instructor, and the need of a place to practice, these programs are commonly complex to implement. For this reason, many of companies, especially companies in manual sectors are turning to another solution, i.e warm-up intervention before work shift. These interventions present on paper numerous advantages such as short duration, no need to specifically allocate a place in companies and the possibility to perform exercises in working clothes… Surprisingly, while positive effects of warm-up interventions on pain, performance physical and psychological capacities, are expansively reported in sport context, effects of workplace warm-up intervention are lacking. Therefore, the aims of this study are (1) to implement such intervention among vineyard-workers, workers highly exposed to heavy physical workload and pain and (2) to assess their effects on physical (pain, strength, flexibility) and psychological (workload) functions and also on work-related outcomes (work performance, readiness to work)
Methods:
A cluster randomized study will be implemented among French vineyard workers. Four groups of 30 participants will be constituted; corresponding to four different conditions: (1) hybrid warm-up intervention (HWU); (2) dynamic warm-up intervention (DWU); (3) stretching warm-up intervention (SWU); (4) no warm-up intervention (NWU). A total of 120 vineyard-workers will be recruited to participate in the study.
Discussion:
The results will provide more evidence about the short-term effects of warm-up interventions at the workplace, and will provide more evidence on which warm-up modality is the most effective on pain, performance, physical and psychological capacities among vineyard workers.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Gironde
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Pauillac, Gironde, Francia, 33250
- OptiMouv
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- working full time
- having at least 1 year of employment in the company
Exclusion Criteria:
- not to present previous surgery in the low back region in the last 12 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Hybrid warm-up intervention
|
Dynamic + stretching exercises
|
|
Experimental: Dynamic warm-up intervention
|
Dynamic exercises
|
|
Experimental: Stretching warm-up intervention
|
Stretching exercises
|
|
Sin intervención: No warm-up intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated for the last 3 months
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated for the last 3 months
|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated before the warm-up intervention (Time 0)
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated before the warm-up intervention (Time 0)
|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated after the warm-up intervention (Time 1)
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated after the warm-up intervention (Time 1)
|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated at the beginning of the working activity (Time 2)
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated at the beginning of the working activity (Time 2)
|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated after the first hour of work (Time 3)
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated after the first hour of work (Time 3)
|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated after the second hour of work (Time 4)
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated after the second hour of work (Time 4)
|
|
Perceived pain intensity
Periodo de tiempo: Pain intensity will be rated after three hour of work (Time 5)
|
Participants will be asked to rate their pain intensity over 15 anatomical locations using a 0-10 numerical rating scale (NRS), where 0 is used to indicate "no pain" while 10 indicate the "worst possible pain".
|
Pain intensity will be rated after three hour of work (Time 5)
|
|
Work performance
Periodo de tiempo: After one hour of work (Time 3)
|
number of grapevine pruned
|
After one hour of work (Time 3)
|
|
Work performance
Periodo de tiempo: After two hours of work (Time 4)
|
number of grapevine pruned
|
After two hours of work (Time 4)
|
|
Work performance
Periodo de tiempo: After three hours of work (Time 5)
|
number of grapevine pruned
|
After three hours of work (Time 5)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Handgrip Strength
Periodo de tiempo: Before the warm-up intervention (Time 0)
|
Handgrip Strength
|
Before the warm-up intervention (Time 0)
|
|
Handgrip Strength
Periodo de tiempo: After the warm-up intervention (Time 1)
|
Handgrip Strength
|
After the warm-up intervention (Time 1)
|
|
Handgrip Strength
Periodo de tiempo: After three hour of work (Time 5)
|
Handgrip Strength
|
After three hour of work (Time 5)
|
|
Flexibility
Periodo de tiempo: Before the warm-up intervention (Time 0)
|
Flexibility of the trunk and the hamstrings - Finger to floor test
|
Before the warm-up intervention (Time 0)
|
|
Flexibility
Periodo de tiempo: After the warm-up intervention (Time 1)
|
Flexibility of the trunk and the hamstrings - Finger to floor test
|
After the warm-up intervention (Time 1)
|
|
Flexibility
Periodo de tiempo: After three hour of work (Time 5)
|
Flexibility of the trunk and the hamstrings - Finger to floor test
|
After three hour of work (Time 5)
|
|
Flexibility
Periodo de tiempo: Before the warm-up intervention (Time 0)
|
Flexibility of the shoulders - Back scratch test
|
Before the warm-up intervention (Time 0)
|
|
Flexibility
Periodo de tiempo: After the warm-up intervention (Time 1)
|
Flexibility of the shoulders - Back scratch test
|
After the warm-up intervention (Time 1)
|
|
Flexibility
Periodo de tiempo: After three hour of work (Time 5)
|
Flexibility of the shoulders - Back scratch test
|
After three hour of work (Time 5)
|
|
Heart rate
Periodo de tiempo: Time 0
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 0
|
|
Heart rate
Periodo de tiempo: Time 1
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 1
|
|
Heart rate
Periodo de tiempo: Time 2
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 2
|
|
Heart rate
Periodo de tiempo: Time 3
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 3
|
|
Heart rate
Periodo de tiempo: Time 4
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 4
|
|
Heart rate
Periodo de tiempo: Time 5
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 5
|
|
Readiness to work
Periodo de tiempo: Time 1
|
Readiness to work was rated subjectively using a 0-10 numerical rating scale, where 0 was used to indicate "not at all ready" and 10 "perfectly ready to work"
|
Time 1
|
|
Readiness to work
Periodo de tiempo: Time 2
|
Readiness to work was rated subjectively using a 0-10 numerical rating scale, where 0 was used to indicate "not at all ready" and 10 "perfectly ready to work"
|
Time 2
|
|
Work quality
Periodo de tiempo: Time 5
|
Work quality will be assessed by the workers supervisors, with the same 0-10 scale in every company, developed by the research team and a vineyard growing specialist.
|
Time 5
|
|
Workload
Periodo de tiempo: Time 5
|
NASA Task Load Index (NASA TLX) is a multi-dimensional scale used to estimate workload from a worker.
|
Time 5
|
|
Visuomotor reaction time
Periodo de tiempo: Time 0
|
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
|
Time 0
|
|
Visuomotor reaction time
Periodo de tiempo: Time 1
|
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
|
Time 1
|
|
Visuomotor reaction time
Periodo de tiempo: Time 5
|
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
|
Time 5
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Nicolas Vuillerme, Phd, UniversitéGrenobleAlpes
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
Otros números de identificación del estudio
- IRB00012476-2021-06-12-137
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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