Efficacy of "Tailored Physical Activity" in Health Care Workers
This study is currently recruiting participants.
Verified April 2013 by University of Southern Denmark
Sponsor:
University of Southern Denmark
Collaborator:
Municipality of Sønderborg
Information provided by (Responsible Party):
Lotte Nygaard Andersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01543984
First received: February 27, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Other: Tailored Physical Activity Behavioral: Health Counselling |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Further study details as provided by University of Southern Denmark:
Primary Outcome Measures:
- Self-reported number of sick-days [ Time Frame: 3 months ] [ Designated as safety issue: No ]"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).
Secondary Outcome Measures:
- Aerobic capacity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Hand-grip strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Body weight, waist circumference, hip circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Self-reported number of sick-days [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]"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).
- Aerobic capacity [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
- Hand-grip strength [ Time Frame: 12- months follow-up ] [ Designated as safety issue: No ]
- Body weight, waist circumference, hip circumference [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
- Questionnaire [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tailored Physical Activity
Health guidance (1,5h) and "Tailored Physical Activity" (3*50 min/week in 10 weeks)
|
Other: Tailored Physical Activity
Tailored Physical Activity (3*50 min/week in 10 weeks)
|
|
Reference group
Health Counselling (1,5h)
|
Behavioral: Health Counselling
Health guidance (1,5h)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543984
Contacts
| Contact: Karen Søgaard, Professor | 004565504409 | ksogaard@health.sdu.dk |
| Contact: Lotte Nygaard Andersen, cand.scient. | 004524407841 | lonygaard@health.sdu.dk |
Locations
| Denmark | |
| Health Care Centre | Recruiting |
| Sønderborg, Denmark, 6400 | |
| Contact: Lene Gram Herborg 004588725192 lghe@sonderborg.dk | |
Sponsors and Collaborators
University of Southern Denmark
Municipality of Sønderborg
Investigators
| Principal Investigator: | Lotte Nygaard Andersen, cand.scient | University of Southern Denmark |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lotte Nygaard Andersen, Ph.d. fellow, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT01543984 History of Changes |
| Other Study ID Numbers: | 95-154-32028T |
| Study First Received: | February 27, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Southern Denmark:
|
health care workers tailored physical activity prevention |
spine upper body pain related to Spine or Upper body |
ClinicalTrials.gov processed this record on June 18, 2013