Participatory Intervention Among Construction Workers (IRMA11) (IRMA11)
Primary Purpose
Musculoskeletal Disorders
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Participatory Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Disorders
Eligibility Criteria
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
Sites / Locations
- National Research Centre for the Working Environment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Participatory Intervention
Control
Arm Description
Participatory intervention with workers and their leaders. Workshops with presentation of work tasks with excessive physical load and subsequently plans to reduce these loads
Receive standard information about correct lifting technics, use of assistive technology, and ergonomics
Outcomes
Primary Outcome Measures
Excessive physical load
The primary outcome of the present study is the change from baseline to follow-up in frequency of events with excessive physical load
Secondary Outcome Measures
Pain intensity (0-10)
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.
WAI questionnaire
Work Ability Index (Ilmarinen et al)
Self-efficacy Questionnaire
Self-efficacy to improve the physical work environment
Full Information
NCT ID
NCT02498197
First Posted
June 29, 2015
Last Updated
August 10, 2018
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT02498197
Brief Title
Participatory Intervention Among Construction Workers (IRMA11)
Acronym
IRMA11
Official Title
Deltagerinvolverende Intervention Mod Fysiske Risikofaktorer for Muskel- og skeletbesvær i Byggebranchen
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Aalborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participatory Intervention
Arm Type
Experimental
Arm Description
Participatory intervention with workers and their leaders. Workshops with presentation of work tasks with excessive physical load and subsequently plans to reduce these loads
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Receive standard information about correct lifting technics, use of assistive technology, and ergonomics
Intervention Type
Behavioral
Intervention Name(s)
Participatory Intervention
Intervention Type
Behavioral
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Excessive physical load
Description
The primary outcome of the present study is the change from baseline to follow-up in frequency of events with excessive physical load
Time Frame
change from baseline to 3 months follow-up
Secondary Outcome Measure Information:
Title
Pain intensity (0-10)
Description
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.
Time Frame
change from baseline to 3 months follow-up
Title
WAI questionnaire
Description
Work Ability Index (Ilmarinen et al)
Time Frame
change from baseline to 3 months follow-up
Title
Self-efficacy Questionnaire
Description
Self-efficacy to improve the physical work environment
Time Frame
change from baseline to 3 months follow-up
Other Pre-specified Outcome Measures:
Title
Social Capital questionnaire
Description
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
Time Frame
change from baseline to 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Andersen, PhD
Organizational Affiliation
National Research Centre for the Working Environment, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
30567694
Citation
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.
Results Reference
derived
PubMed Identifier
26474867
Citation
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.
Results Reference
derived
Learn more about this trial
Participatory Intervention Among Construction Workers (IRMA11)
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