NCT05425693

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

June 13, 2022

Last Update Submit

June 16, 2022

Conditions

Keywords

Pain / injuries / warm-up intervention / vineyard workers / physical activity

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Work performance

    number of grapevine pruned

    After one hour of work (Time 3)

  • Work performance

    number of grapevine pruned

    After two hours of work (Time 4)

  • Work performance

    number of grapevine pruned

    After three hours of work (Time 5)

Secondary Outcomes (22)

  • Handgrip Strength

    Before the warm-up intervention (Time 0)

  • Handgrip Strength

    After the warm-up intervention (Time 1)

  • Handgrip Strength

    After three hour of work (Time 5)

  • Flexibility

    Before the warm-up intervention (Time 0)

  • Flexibility

    After the warm-up intervention (Time 1)

  • +17 more secondary outcomes

Study Arms (4)

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

Interventions

Dynamic + stretching exercises

Hybrid warm-up intervention

Dynamic exercises

Dynamic warm-up intervention

Stretching exercises

Stretching warm-up intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • working full time
  • having at least 1 year of employment in the company

You may not qualify if:

  • \- not to present previous surgery in the low back region in the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OptiMouv

Pauillac, Gironde, 33250, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

PainWounds and InjuriesMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nicolas Vuillerme, Phd

    UniversitéGrenobleAlpes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 21, 2022

Study Start

November 1, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations