- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498197
Participatory Intervention Among Construction Workers (IRMA11) (IRMA11)
Deltagerinvolverende Intervention Mod Fysiske Risikofaktorer for Muskel- og skeletbesvær i Byggebranchen
There is high prevalence of back pain and neck-shoulder pain among blue collar workers. Physical excessive exposures such as heavy lifting or working with a bended or twisted back are independent risk factors for back pain among workers in the construction industry. Participatory ergonomic initiatives increase the success of interventions aimed at reducing physical excessive exposures.
The objectives are in two phases to; 1) determine which work-tasks in selected job-groups involve the highest load of the back and shoulders during a normal working day (using EMG, Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical workloads, drawing on information from objective measurements from phase 1.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- National Research Centre for the Working Environment
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full time construction workers who are member of a labor union and can read and understand Danish.
- The type of work must include manual work that involves lifting
Exclusion Criteria:
- life-threatening diseases
- pregnancy
- hypertension >160/100 mmHg
- unable to participate in the measurements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participatory Intervention
Participatory intervention with workers and their leaders.
Workshops with presentation of work tasks with excessive physical load and subsequently plans to reduce these loads
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Active Comparator: Control
Receive standard information about correct lifting technics, use of assistive technology, and ergonomics
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excessive physical load
Time Frame: change from baseline to 3 months follow-up
|
The primary outcome of the present study is the change from baseline to follow-up in frequency of events with excessive physical load
|
change from baseline to 3 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity (0-10)
Time Frame: change from baseline to 3 months follow-up
|
Change in "low back pain intensity during the last week" from baseline to follow-up.
A horizontally oriented modified VAS scale will be used with 11 points from 0 to 10.
|
change from baseline to 3 months follow-up
|
WAI questionnaire
Time Frame: change from baseline to 3 months follow-up
|
Work Ability Index (Ilmarinen et al)
|
change from baseline to 3 months follow-up
|
Self-efficacy Questionnaire
Time Frame: change from baseline to 3 months follow-up
|
Self-efficacy to improve the physical work environment
|
change from baseline to 3 months follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Capital questionnaire
Time Frame: change from baseline to 3 months follow-up
|
Social Capital within work teams, between work teams, and between teams and their leaders Reference for questionnaire: http://www.ncbi.nlm.nih.gov/pubmed/26261190
|
change from baseline to 3 months follow-up
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Brandt M, Madeleine P, Samani A, Ajslev JZ, Jakobsen MD, Sundstrup E, Andersen LL. Effects of a Participatory Ergonomics Intervention With Wearable Technical Measurements of Physical Workload in the Construction Industry: Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Dec 19;20(12):e10272. doi: 10.2196/10272.
- Brandt M, Madeleine P, Ajslev JZ, Jakobsen MD, Samani A, Sundstrup E, Kines P, Andersen LL. Participatory intervention with objectively measured physical risk factors for musculoskeletal disorders in the construction industry: study protocol for a cluster randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 16;16:302. doi: 10.1186/s12891-015-0758-0.
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRMA11
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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