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

Stress Clinical Trial

— IRMA10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047682
• Other study ID #: IRMA10
• Status: Completed
• Phase: N/A
• First received: January 26, 2014
• Last updated: September 29, 2014
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: National Research Centre for the Working Environment, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 67 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Disorders
• Stress

Intervention

Behavioral:
• Biopsychosocial

• Reference

Locations

Country	Name	City	State
Denmark	National Research Centre for the Working Environment	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark	University of Southampton

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No