- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01027390
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS)
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS, Danish Acronym)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Rigspolitiet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- office workers
- employed
Exclusion Criteria:
- physically heavy work
- trauma
- leif threatening disease, e.g. cancer,
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 hr training 50% supervision
|
physical exercise training at the work site during work time
|
Experimental: 3 x 20 min training 50% supervision
|
physical exercise training at the work site during work time
|
Experimental: 3 x 20 min training initial instructions
|
physical exercise training at the work site during work time
|
Experimental: 10 x 6 min training 50% supervision
|
physical exercise training at the work site during work time
|
No Intervention: reference
no training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
neck/shoulder pain, selfreported
Time Frame: 20 weeks
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle strength and endurance
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gisela Sjogaard, Dr.Med.Sci., University of Southern Denmark
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-2008-103
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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