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

September 29, 2014 updated by: Lars L. Andersen, National Research Centre for the Working Environment, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • National Research Centre for the Working Environment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMG gaps
Time Frame: change from baseline to week 10
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
Time Frame: change from baseline to week 10
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
Time Frame: change from baseline til 10 week followup
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre for the Working Environment, Denmark

Collaborators

University of Southampton

Investigators

  • Principal Investigator: Lars L Andersen, PhD, National Research Centre for the Working Environment, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 26, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRMA10

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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