Efficacy of "Tailored Physical Activity" in Health Care Workers

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543984
• Other study ID #: 95-154-32028T
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 27, 2012
• Last updated: November 19, 2015
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Tailored Physical Activity
Tailored Physical Activity (3*50 min/week in 10 weeks)

Behavioral:
• Health Counselling
Health guidance (1,5h)

Locations

Country	Name	City	State
Denmark	Health Care Centre	Sønderborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Municipality of Sønderborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported number of sick-days	"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	No
Secondary	Aerobic capacity		3 months	No
Secondary	Hand-grip strength		3 months	No
Secondary	Body weight, waist circumference, hip circumference		3 months	No
Secondary	Questionnaire		3 months	No
Secondary	Self-reported number of sick-days	"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	No
Secondary	Aerobic capacity		12 months follow-up	No
Secondary	Hand-grip strength		12- months follow-up	No
Secondary	Body weight, waist circumference, hip circumference		12 months follow-up	No
Secondary	Questionnaire		12 months follow-up	No

External Links

•   University of Southern Denmark