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

Primary Purpose

Musculoskeletal Disorders, Stress

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Biopsychosocial
Reference
Sponsored by
National Research Centre for the Working Environment, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Musculoskeletal Disorders

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • National Research Centre for the Working Environment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biopsychosocial

Reference

Arm Description

Biopsychosocial intervention with Individually tailored physical exercises and stress management

Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
January 26, 2014
Last Updated
September 29, 2014
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
University of Southampton
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1. Study Identification

Unique Protocol Identification Number
NCT02047682
Brief Title
Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load
Acronym
IRMA10
Official Title
Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
University of Southampton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders, Stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biopsychosocial
Arm Type
Experimental
Arm Description
Biopsychosocial intervention with Individually tailored physical exercises and stress management
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
Reference group receiving "usual care" in terms of standard workplace ergonomics and physical exercises
Intervention Type
Behavioral
Intervention Name(s)
Biopsychosocial
Intervention Type
Behavioral
Intervention Name(s)
Reference
Primary Outcome Measure Information:
Title
EMG gaps
Description
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)
Time Frame
change from baseline to week 10
Secondary Outcome Measure Information:
Title
EEG
Description
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)
Time Frame
change from baseline to week 10
Title
HRV
Description
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)
Time Frame
change from baseline til 10 week followup

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Principal Investigator
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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

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