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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05425693
Other study ID # IRB00012476-2021-06-12-137
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date May 31, 2022

Study information

Verified date June 2022
Source Opti'Mouv
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hybrid Warm-up
Dynamic + stretching exercises
Dynamic Warm-up
Dynamic exercises
Stretching Warm-up
Stretching exercises

Locations

Country Name City State
France OptiMouv Pauillac Gironde

Sponsors (2)

Lead Sponsor Collaborator
Opti'Mouv Université Grenoble-Alpes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived pain intensity 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
Primary Perceived pain intensity 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)
Primary Perceived pain intensity 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)
Primary Perceived pain intensity 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)
Primary Perceived pain intensity 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)
Primary Perceived pain intensity 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)
Primary Perceived pain intensity 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)
Primary Work performance number of grapevine pruned After one hour of work (Time 3)
Primary Work performance number of grapevine pruned After two hours of work (Time 4)
Primary Work performance number of grapevine pruned After three hours of work (Time 5)
Secondary Handgrip Strength Handgrip Strength Before the warm-up intervention (Time 0)
Secondary Handgrip Strength Handgrip Strength After the warm-up intervention (Time 1)
Secondary Handgrip Strength Handgrip Strength After three hour of work (Time 5)
Secondary Flexibility Flexibility of the trunk and the hamstrings - Finger to floor test Before the warm-up intervention (Time 0)
Secondary Flexibility Flexibility of the trunk and the hamstrings - Finger to floor test After the warm-up intervention (Time 1)
Secondary Flexibility Flexibility of the trunk and the hamstrings - Finger to floor test After three hour of work (Time 5)
Secondary Flexibility Flexibility of the shoulders - Back scratch test Before the warm-up intervention (Time 0)
Secondary Flexibility Flexibility of the shoulders - Back scratch test After the warm-up intervention (Time 1)
Secondary Flexibility Flexibility of the shoulders - Back scratch test After three hour of work (Time 5)
Secondary Heart rate Heart rate with a heart rate monitor placed on the wrist Time 0
Secondary Heart rate Heart rate with a heart rate monitor placed on the wrist Time 1
Secondary Heart rate Heart rate with a heart rate monitor placed on the wrist Time 2
Secondary Heart rate Heart rate with a heart rate monitor placed on the wrist Time 3
Secondary Heart rate Heart rate with a heart rate monitor placed on the wrist Time 4
Secondary Heart rate Heart rate with a heart rate monitor placed on the wrist Time 5
Secondary Readiness to work 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
Secondary Readiness to work 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
Secondary Work quality 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
Secondary Workload NASA Task Load Index (NASA TLX) is a multi-dimensional scale used to estimate workload from a worker. Time 5
Secondary Visuomotor reaction time The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT). Time 0
Secondary Visuomotor reaction time The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT). Time 1
Secondary Visuomotor reaction time The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT). Time 5
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