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Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers (IRMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01921764
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):
Lars L. Andersen, National Research Centre for the Working Environment, Denmark

Tracking Information
First Submitted Date  ICMJE August 10, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date January 28, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2013)
Pain intensity [ Time Frame: change from baseline to week 10 ]
The change in "pain intensity during the last week" from baseline to 10 week follow-up between the workplace- and home-training group. The home-training group will be considered the reference group. 2-way analysis of variance (Proc Mixed of SAS) with repeated measures will be used, with time and group as fixed factors and subject as random factor. Department will be added as a cluster effect.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2013)
  • Muscle function [ Time Frame: change from baseline to week 10 ]
  • Work ability index (WAI) [ Time Frame: change from baseline to week 10 ]
  • Physical exertion during work [ Time Frame: change from baseline to week 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers
Official Title  ICMJE Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers
Brief Summary

The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous studies have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or in the private sphere at home. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase compliance. On the other hand, physical exercise at the workplace may be costly for the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study investigates the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers.

The main hypothesis is that physical exercise at the workplace for 10 weeks compared with physical exercise at home results in reduced musculoskeletal pain among healthcare workers.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Musculoskeletal Disorders
Intervention  ICMJE
  • Behavioral: Workplace physical exercise
  • Behavioral: Home physical exercise
Study Arms  ICMJE
  • Experimental: Workplace physical exercise
    Physical exercise (kettlebells, elastic bands, exercise balls) performed at the workplace with coaching
    Intervention: Behavioral: Workplace physical exercise
  • Active Comparator: Home physical exercise
    Physical exercise performed at home with elastic bands and bodyweight exercises with instruction to follow the exercises at http://www.jobogkrop.dk/Oevelser-til-nakke-og-ryg/Oevelser
    Intervention: Behavioral: Home physical exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthcare worker
  • female
  • age 18-67

Exclusion Criteria:

  • life threatening disease
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921764
Other Study ID Numbers  ICMJE IRMA08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lars L. Andersen, National Research Centre for the Working Environment, Denmark
Study Sponsor  ICMJE National Research Centre for the Working Environment, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Research Centre for the Working Environment, Denmark
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP