Exercise and Low Back Pain

February 22, 2017 updated by: Sven Haufe, Hannover Medical School

Effects of a Home-based Exercise Program on Low Back Pain in Employees

Evaluation of the effectiveness of an individually educated exercise program for the lower back at home in employees over a period of 20 weeks.

We hypothesize that regular exercise for the lower back results in greater improvements of low back strengths compared to controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women
  • age between 18 and 67 years

Exclusion Criteria:

  • beeing currently involved in an exercise program for the lower back
  • known drug or alcohol abuse
  • any disease that excludes the participation in an exercise program
  • clinical relevant acute or chronic infections
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Exercise
Behavioral: Exercise
Educated exercise training for the trunk 3 times per week, each for 20 min. Recommendation of additional fitness courses as offered by the local healthy insurance company.
No Intervention: Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back strength (kg)
Time Frame: At baseline and after 20 weeks
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
At baseline and after 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strenght at lateral flexion of the trunk (kg)
Time Frame: At baseline and after 20 weeks
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
At baseline and after 20 weeks
Oswestry Low Back Pain Disability Score
Time Frame: At baseline and after 20 weeks
Assessed with the Oswestry Low Back Pain Disability questionaire
At baseline and after 20 weeks
Pain (scale)
Time Frame: At baseline and after 20 weeks
Assessed with the visual analog scale
At baseline and after 20 weeks
Quality of life (score)
Time Frame: At baseline and after 20 weeks
Assessed with the short form 36 questionaire
At baseline and after 20 weeks
Work ability index (score)
Time Frame: At baseline and afetr 20 weeks
Assessed with the WAI questionaire
At baseline and afetr 20 weeks
Physical activity (score)
Time Frame: At baseline and after 20 weeks
Assessed with the "Freiburger activity questionaire"
At baseline and after 20 weeks
Fat mass and fat-free mass (kg)
Time Frame: At baseline and after 20 weeks
Assessed with Bio Impedance Analysis
At baseline and after 20 weeks
sick days (numbers)
Time Frame: At baseline and after 20 weeks
sick days at work will be assessed for the 20 weeks of the active intervention and the whole year the intervention is conducted
At baseline and after 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SpoMed Low Back

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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