- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gironde
-
Pauillac, Gironde, France, 33250
- OptiMouv
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hybrid warm-up intervention
|
Dynamic + stretching exercises
|
|
Experimental: Dynamic warm-up intervention
|
Dynamic exercises
|
|
Experimental: Stretching warm-up intervention
|
Stretching exercises
|
|
No Intervention: No warm-up intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived pain intensity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: After one hour of work (Time 3)
|
number of grapevine pruned
|
After one hour of work (Time 3)
|
|
Work performance
Time Frame: After two hours of work (Time 4)
|
number of grapevine pruned
|
After two hours of work (Time 4)
|
|
Work performance
Time Frame: After three hours of work (Time 5)
|
number of grapevine pruned
|
After three hours of work (Time 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Handgrip Strength
Time Frame: Before the warm-up intervention (Time 0)
|
Handgrip Strength
|
Before the warm-up intervention (Time 0)
|
|
Handgrip Strength
Time Frame: After the warm-up intervention (Time 1)
|
Handgrip Strength
|
After the warm-up intervention (Time 1)
|
|
Handgrip Strength
Time Frame: After three hour of work (Time 5)
|
Handgrip Strength
|
After three hour of work (Time 5)
|
|
Flexibility
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Before the warm-up intervention (Time 0)
|
Flexibility of the shoulders - Back scratch test
|
Before the warm-up intervention (Time 0)
|
|
Flexibility
Time Frame: After the warm-up intervention (Time 1)
|
Flexibility of the shoulders - Back scratch test
|
After the warm-up intervention (Time 1)
|
|
Flexibility
Time Frame: After three hour of work (Time 5)
|
Flexibility of the shoulders - Back scratch test
|
After three hour of work (Time 5)
|
|
Heart rate
Time Frame: Time 0
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 0
|
|
Heart rate
Time Frame: Time 1
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 1
|
|
Heart rate
Time Frame: Time 2
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 2
|
|
Heart rate
Time Frame: Time 3
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 3
|
|
Heart rate
Time Frame: Time 4
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 4
|
|
Heart rate
Time Frame: Time 5
|
Heart rate with a heart rate monitor placed on the wrist
|
Time 5
|
|
Readiness to work
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Time 5
|
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
|
Time 5
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Nicolas Vuillerme, Phd, UniversitéGrenobleAlpes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00012476-2021-06-12-137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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