Efficacy of "Tailored Physical Activity" in Health Care Workers

This study is ongoing, but not recruiting participants.
Sponsor:
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: February 3, 2014
Last verified: February 2014
  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 ]

Enrollment: 54
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: June 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

Locations
Denmark
Health Care Centre
Sønderborg, Denmark, 6400
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 by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 3, 2014
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 April 17, 2014