Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS)
Primary Purpose
Musculoskeletal Disorders
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
physical training exercise
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Disorders focused on measuring neck/shoulder
Eligibility Criteria
Inclusion Criteria:
- office workers
- employed
Exclusion Criteria:
- physically heavy work
- trauma
- leif threatening disease, e.g. cancer,
- pregnancy
Sites / Locations
- Rigspolitiet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
1 hr training 50% supervision
3 x 20 min training 50% supervision
3 x 20 min training initial instructions
10 x 6 min training 50% supervision
reference
Arm Description
1 hr training 50% supervision
3 x 20 min training 50% supervision
3 x 20 min training initial instructions
10 x 6 min training 50% supervision
no training
Outcomes
Primary Outcome Measures
neck/shoulder pain, selfreported
Secondary Outcome Measures
muscle strength and endurance
Full Information
NCT ID
NCT01027390
First Posted
December 7, 2009
Last Updated
December 8, 2012
Sponsor
University of Southern Denmark
Collaborators
National Research Centre for the Working Environment, Denmark, University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01027390
Brief Title
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
Acronym
VIMS
Official Title
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS, Danish Acronym)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
National Research Centre for the Working Environment, Denmark, University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder area.
The hypothesis is, that specific strength training of the neck/shoulder muscles will alleviate the pain.
The two sub-hypotheses are
Alleviation of pain is independent of training frequency
Alleviation of pain is higher following supervised training vs training with initial instruction only
Detailed Description
Recent studies have shown a positive effect of work site physical exercise intervention, however, there is a lack of evidence regarding: 1) extend of instruction and supervision, and 2) frequency of training session during the wek.
Questionnaires will be send to around 2000 office workers inviting them to participate in work site training for 1 hr per week for 20 weeks. Those accepting the invitation will be randomized into 5 different groups:
training 1 hr one time per week supervized 50% of the time
training 3 x 20 min per week supervised 50 % of the time
training 3 x 20 min per week supervised only initially with careful instructions
training 10 x 6 min per week supervised 50 % of the time
no training serving as reference control group At termination of the training period there will be a follow-up questionnaire survey
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders
Keywords
neck/shoulder
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
573 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 hr training 50% supervision
Arm Type
Experimental
Arm Description
1 hr training 50% supervision
Arm Title
3 x 20 min training 50% supervision
Arm Type
Experimental
Arm Description
3 x 20 min training 50% supervision
Arm Title
3 x 20 min training initial instructions
Arm Type
Experimental
Arm Description
3 x 20 min training initial instructions
Arm Title
10 x 6 min training 50% supervision
Arm Type
Experimental
Arm Description
10 x 6 min training 50% supervision
Arm Title
reference
Arm Type
No Intervention
Arm Description
no training
Intervention Type
Behavioral
Intervention Name(s)
physical training exercise
Intervention Description
physical exercise training at the work site during work time
Primary Outcome Measure Information:
Title
neck/shoulder pain, selfreported
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
muscle strength and endurance
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
office workers
employed
Exclusion Criteria:
physically heavy work
trauma
leif threatening disease, e.g. cancer,
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisela Sjogaard, Dr.Med.Sci.
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigspolitiet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22753863
Citation
Andersen CH, Andersen LL, Gram B, Pedersen MT, Mortensen OS, Zebis MK, Sjogaard G. Influence of frequency and duration of strength training for effective management of neck and shoulder pain: a randomised controlled trial. Br J Sports Med. 2012 Nov;46(14):1004-10. doi: 10.1136/bjsports-2011-090813. Epub 2012 Jun 29.
Results Reference
result
PubMed Identifier
20687940
Citation
Andersen LL, Zebis MK, Pedersen MT, Roessler KK, Andersen CH, Pedersen MM, Feveile H, Mortensen OS, Sjogaard G. Protocol for work place adjusted intelligent physical exercise reducing musculoskeletal pain in shoulder and neck (VIMS): a cluster randomized controlled trial. BMC Musculoskelet Disord. 2010 Aug 5;11:173. doi: 10.1186/1471-2474-11-173.
Results Reference
result
PubMed Identifier
25816746
Citation
Dalager T, Bredahl TG, Pedersen MT, Boyle E, Andersen LL, Sjogaard G. Does training frequency and supervision affect compliance, performance and muscular health? A cluster randomized controlled trial. Man Ther. 2015 Oct;20(5):657-65. doi: 10.1016/j.math.2015.01.016. Epub 2015 Feb 28.
Results Reference
derived
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Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
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