PainNCT05425693
Effects of Three Warm-up Interventions at the Workplace Among Vineyard Workers - a Protocol Study
A study testing Hybrid Warm-up, Dynamic Warm-up and Stretching Warm-up in people with Pain and Injuries, run by Opti'Mouv at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Hybrid Warm-up, Dynamic Warm-up and Stretching Warm-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- working full time
- having at least 1 year of employment in the company
Who cannot join
- not to present previous surgery in the low back region in the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read more
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.
- Being tested
- Hybrid Warm-up, Dynamic Warm-up, Stretching Warm-up
- Keywords
- Pain / injuries / warm-up intervention / vineyard workers / physical activity
- Medical subject headings
- Pain, Wounds and Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Warm-upOther
Dynamic + stretching exercises
Dynamic Warm-upOther
Dynamic exercises
Stretching Warm-upOther
Stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Hybrid warm-up intervention | Experimental | Not described Receives: Other: Hybrid Warm-up |
| Dynamic warm-up intervention | Experimental | Not described Receives: Other: Dynamic Warm-up |
| Stretching warm-up intervention | Experimental | Not described Receives: Other: Stretching Warm-up |
| No warm-up intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Pain intensity will be rated for the last 3 months
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".
Measured: Pain intensity will be rated before the warm-up intervention (Time 0)
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".
Measured: Pain intensity will be rated after the warm-up intervention (Time 1)
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".
Measured: Pain intensity will be rated at the beginning of the working activity (Time 2)
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".
Measured: Pain intensity will be rated after the first hour of work (Time 3)
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".
Measured: Pain intensity will be rated after the second hour of work (Time 4)
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".
Measured: Pain intensity will be rated after three hour of work (Time 5)
Work performance
number of grapevine pruned
Measured: After one hour of work (Time 3)
Work performance
number of grapevine pruned
Measured: After two hours of work (Time 4)
Work performance
number of grapevine pruned
Measured: After three hours of work (Time 5)
Secondary outcomes (22)
Handgrip Strength
Handgrip Strength
Measured: Before the warm-up intervention (Time 0)
Handgrip Strength
Handgrip Strength
Measured: After the warm-up intervention (Time 1)
Handgrip Strength
Handgrip Strength
Measured: After three hour of work (Time 5)
Flexibility
Flexibility of the trunk and the hamstrings - Finger to floor test
Measured: Before the warm-up intervention (Time 0)
Flexibility
Flexibility of the trunk and the hamstrings - Finger to floor test
Measured: After the warm-up intervention (Time 1)
Flexibility
Flexibility of the trunk and the hamstrings - Finger to floor test
Measured: After three hour of work (Time 5)
Flexibility
Flexibility of the shoulders - Back scratch test
Measured: Before the warm-up intervention (Time 0)
Flexibility
Flexibility of the shoulders - Back scratch test
Measured: After the warm-up intervention (Time 1)
Flexibility
Flexibility of the shoulders - Back scratch test
Measured: After three hour of work (Time 5)
Heart rate
Heart rate with a heart rate monitor placed on the wrist
Measured: Time 0
Heart rate
Heart rate with a heart rate monitor placed on the wrist
Measured: Time 1
Heart rate
Heart rate with a heart rate monitor placed on the wrist
Measured: Time 2
Heart rate
Heart rate with a heart rate monitor placed on the wrist
Measured: Time 3
Heart rate
Heart rate with a heart rate monitor placed on the wrist
Measured: Time 4
Heart rate
Heart rate with a heart rate monitor placed on the wrist
Measured: Time 5
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"
Measured: Time 1
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"
Measured: Time 2
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.
Measured: Time 5
Workload
NASA Task Load Index (NASA TLX) is a multi-dimensional scale used to estimate workload from a worker.
Measured: Time 5
Visuomotor reaction time
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
Measured: Time 0
Visuomotor reaction time
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
Measured: Time 1
Visuomotor reaction time
The FITLIGHT Trainer (FITLIGHT Sports Corp., Ontario, Canada) will be used to measure the visuomotor reaction time (VMRT).
Measured: Time 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Nov 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opti'Mouv
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Nicolas Vuillerme, Phd, Study director, UniversitéGrenobleAlpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425693
- Sponsor's protocol ID
- IRB00012476-2021-06-12-137
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larinier N, Vuillerme N, Jadaud A, Malherbe S, Giraud E, Balaguier R. Acute Effects of a Warm-Up Intervention on Pain, Productivity, Physical Capacities and Psychological Perceptions Among Vineyard Workers: a Cluster Randomized Trial. J Occup Rehabil. 2024 Mar;34(1):100-115. doi: 10.1007/s10926-023-10134-2. Epub 2023 Aug 28.
PubMed 37635160
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05425693
- Acronym / sponsor ID
- IRB00012476-2021-06-12-137
- Keywords
- Pain / injuries / warm-up intervention / vineyard workers / physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Opti'MouvIndustry (pharma, biotech, devices)
- Collaborators
- University Grenoble Alps
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hybrid warm-up intervention | Experimental | Other: Hybrid Warm-up |
| Dynamic warm-up intervention | Experimental | Other: Dynamic Warm-up |
| Stretching warm-up intervention | Experimental | Other: Stretching Warm-up |
| No warm-up intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- working full time
- having at least 1 year of employment in the company
Key exclusion criteria (1 listed)
- not to present previous surgery in the low back region in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Warm-upDynamic + stretching exercises | Other | Hybrid warm-up intervention |
| Dynamic Warm-upDynamic exercises | Other | Dynamic warm-up intervention |
| Stretching Warm-upStretching exercises | Other | Stretching warm-up intervention |
Primary outcome
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".
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".
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".
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".
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".
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".
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".
Work performance
Time frame: After one hour of work (Time 3)
number of grapevine pruned
Work performance
Time frame: After two hours of work (Time 4)
number of grapevine pruned
Work performance
Time frame: After three hours of work (Time 5)
number of grapevine pruned
22 secondary outcomes
Handgrip Strength
Time frame: Before the warm-up intervention (Time 0)
Handgrip Strength
Time frame: After the warm-up intervention (Time 1)
Handgrip Strength
Time frame: After three hour of work (Time 5)
Flexibility
Time frame: Before the warm-up intervention (Time 0)
Flexibility
Time frame: After the warm-up intervention (Time 1)
Flexibility
Time frame: After three hour of work (Time 5)
Flexibility
Time frame: Before the warm-up intervention (Time 0)
Flexibility
Time frame: After the warm-up intervention (Time 1)
Flexibility
Time frame: After three hour of work (Time 5)
Heart rate
Time frame: Time 0
Heart rate
Time frame: Time 1
Heart rate
Time frame: Time 2
Heart rate
Time frame: Time 3
Heart rate
Time frame: Time 4
Heart rate
Time frame: Time 5
Readiness to work
Time frame: Time 1
Readiness to work
Time frame: Time 2
Work quality
Time frame: Time 5
Workload
Time frame: Time 5
Visuomotor reaction time
Time frame: Time 0
Visuomotor reaction time
Time frame: Time 1
Visuomotor reaction time
Time frame: Time 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 37635160Larinier N, Vuillerme N, Jadaud A, Malherbe S, Giraud E, Balaguier R. Acute Effects of a Warm-Up Intervention on Pain, Productivity, Physical Capacities and Psychological Perceptions Among Vineyard Workers: a Cluster Randomized Trial. J Occup Rehabil. 2024 Mar;34(1):100-115. doi: 10.1007/s10926-023-10134-2. Epub 2023 Aug 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Vuillerme, Phd study director
UniversitéGrenobleAlpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Warm-up, Dynamic Warm-up and Stretching Warm-up in people with Pain and Injuries, run by Opti'Mouv at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived pain intensity (time frame: Pain intensity will be rated for the last 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05425693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.