Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load
IRMA10
1 other identifier
interventional
36
1 country
1
Brief Summary
Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal disorders and sickness absence. Objective measurements of occupational loadings - EMG for muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate variability, actigraphy for bodily movements - may provide useful early indicators of muscular, cognitive and cardiovascular overload. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on these risk factors in lab technicians with a history of work-related musculoskeletal pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedSeptember 30, 2014
September 1, 2014
5 months
January 26, 2014
September 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
EMG gaps
Electromyography (EMG) is measured in the neck and shoulder muscles throughout a normal workday before and after the intervention. EMG gaps is defined as periods with muscular inactivity. Actigraphs are used to measure bodily movements, and only period with sitting or standing work are included in the analysis (i.e. walking activities are excluded from the analyses)
change from baseline to week 10
Secondary Outcomes (2)
EEG
change from baseline to week 10
HRV
change from baseline til 10 week followup
Study Arms (2)
Biopsychosocial
EXPERIMENTALBiopsychosocial intervention with Individually tailored physical exercises and stress management
Reference
ACTIVE COMPARATORReference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises
Interventions
Eligibility Criteria
You may qualify if:
- Laboratory technician
- Pain intensity \>= 3 (scale of 0-10)
- Pain duration \>= 3 months
- Pain frequency \>= 3 days per week
You may not qualify if:
- life threatening disease
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Research Centre for the Working Environment
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars L Andersen, PhD
National Research Centre for the Working Environment, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD
Study Record Dates
First Submitted
January 26, 2014
First Posted
January 28, 2014
Study Start
February 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
September 30, 2014
Record last verified: 2014-09