- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01543984
Efficacy of "Tailored Physical Activity" in Health Care Workers
Efficacy of "Tailored Physical Activity" on the Number of Sick Days: a Randomized Controlled Trial in Health Care Workers That Have Experienced Pain Related to the Spine or Upper Body
The purpose of this study is to test the effect of "Tailored Physical Activity" on the number of sick-days.
The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Health care workers have high prevalence of musculoskeletal pain. Pain in the back and neck and other musculoskeletal disorders are the leading cause for long-term sick leave.
This study test the effect of "Tailored Physical Activity" on self-reported days on sick leave and parameters regarding pain, function and quality of life respectively on the body function and participation level of health care workers which have experienced musculoskeletal pain related to the back or upper body.
A minimum of 44 health care workers in DK-Sønderborg Municipality will be randomized for "Tailored Physical Activity" or a reference group.
Primary endpoint is 3 months and 12 months follow-up.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Sønderborg, Denmark, 6400
- Health Care Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Health care workers in municipality of Sønderborg that have experienced musculoskeletal pain related to the spine or upper body.
Exclusion Criteria:
Medically safety.
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: Tailored Physical Activity
Health guidance (1,5h) and "Tailored Physical Activity" (3*50 min/week in 10 weeks)
|
Tailored Physical Activity (3*50 min/week in 10 weeks)
|
Other: Reference group
Health Counselling (1,5h)
|
Health guidance (1,5h)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported number of sick-days
Time Frame: 3 months
|
"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months" ((0 days, 1-7 days, 8-30 days, 30 days).
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic capacity
Time Frame: 3 months
|
3 months
|
|
Body weight, waist circumference, hip circumference
Time Frame: 3 months
|
3 months
|
|
Questionnaire
Time Frame: 3 months
|
3 months
|
|
Body weight, waist circumference, hip circumference
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Hand-grip strength
Time Frame: 3 months
|
3 months
|
|
Self-reported number of sick-days
Time Frame: 12 months follow-up
|
"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months" ((0 days, 1-7 days, 8-30 days, 30 days).
|
12 months follow-up
|
Aerobic capacity
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Hand-grip strength
Time Frame: 12- months follow-up
|
12- months follow-up
|
|
Questionnaire
Time Frame: 12 months follow-up
|
12 months follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lotte Nygaard Andersen, cand.scient, University of Southern Denmark
Publications and helpful links
General Publications
- Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' on reducing sickness absence among health care workers: A 3-months randomised controlled trial. Man Ther. 2015 Oct;20(5):666-71. doi: 10.1016/j.math.2015.04.017. Epub 2015 May 2.
- Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' in reducing sickness absence among health care workers: design of a randomised controlled trial. BMC Public Health. 2013 Oct 2;13:917. doi: 10.1186/1471-2458-13-917.
Helpful Links
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
Other Study ID Numbers
- 95-154-32028T
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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