- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Gironde
-
Pauillac, Gironde, Francie, 33250
- OptiMouv
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Hybrid warm-up intervention
|
Dynamic + stretching exercises
|
|
Experimentální: Dynamic warm-up intervention
|
Dynamic exercises
|
|
Experimentální: Stretching warm-up intervention
|
Stretching exercises
|
|
Žádný zásah: No warm-up intervention
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Perceived pain intensity
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: After one hour of work (Time 3)
|
number of grapevine pruned
|
After one hour of work (Time 3)
|
|
Work performance
Časové okno: After two hours of work (Time 4)
|
number of grapevine pruned
|
After two hours of work (Time 4)
|
|
Work performance
Časové okno: After three hours of work (Time 5)
|
number of grapevine pruned
|
After three hours of work (Time 5)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Handgrip Strength
Časové okno: Before the warm-up intervention (Time 0)
|
Handgrip Strength
|
Before the warm-up intervention (Time 0)
|
|
Handgrip Strength
Časové okno: After the warm-up intervention (Time 1)
|
Handgrip Strength
|
After the warm-up intervention (Time 1)
|
|
Handgrip Strength
Časové okno: After three hour of work (Time 5)
|
Handgrip Strength
|
After three hour of work (Time 5)
|
|
Flexibility
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Before the warm-up intervention (Time 0)
|
Flexibility of the shoulders - Back scratch test
|
Before the warm-up intervention (Time 0)
|
|
Flexibility
Časové okno: After the warm-up intervention (Time 1)
|
Flexibility of the shoulders - Back scratch test
|
After the warm-up intervention (Time 1)
|
|
Flexibility
Časové okno: After three hour of work (Time 5)
|
Flexibility of the shoulders - Back scratch test
|
After three hour of work (Time 5)
|
|
Heart rate
Časové okno: Time 0
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 0
|
|
Heart rate
Časové okno: Time 1
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 1
|
|
Heart rate
Časové okno: Time 2
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 2
|
|
Heart rate
Časové okno: Time 3
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 3
|
|
Heart rate
Časové okno: Time 4
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 4
|
|
Heart rate
Časové okno: Time 5
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 5
|
|
Readiness to work
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Time 5
|
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
|
Time 5
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Nicolas Vuillerme, Phd, UniversitéGrenobleAlpes
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- IRB00012476-2021-06-12-137
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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