Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load

Study Overview
=================
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.

Official Title
-----------------
Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load

Conditions
-----------------
Musculoskeletal Disorders, Stress

Intervention / Treatment
-----------------
* Behavioral: Biopsychosocial
* Behavioral: Reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboratory technician Pain intensity >= 3 (scale of 0-10) Pain duration >= 3 months Pain frequency >= 3 days per week Exclusion Criteria: life threatening disease pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsychosocial<br>Biopsychosocial intervention with Individually tailored physical exercises and stress management | Behavioral: Biopsychosocial<br> <br> |
| Active Comparator: Reference<br>Reference group receiving usual care in terms of standard workplace ergonomics and physical exercises | Behavioral: Reference<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG | Electroencephalography is measured throughout a normal workday before and after the intervention. 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 | 
| HRV | Heart Rate Variability (HRV) is measured with Actiheart throughout the working day before and after the intervention. 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 til 10 week followup |