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OpenTrials
Completed

NCT Number: NCT02029131

Exercise and Low Back Pain

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.

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Key information

Conditions

Healthy Volunteers With and Without Chronic Low Back Pain

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  1. Back strength (kg)

    Time frame: At baseline and after 20 weeks

    Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)

Secondary outcomes

  1. 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)

  2. Oswestry Low Back Pain Disability Score

    Time frame: At baseline and after 20 weeks

    Assessed with the Oswestry Low Back Pain Disability questionaire

  3. Pain (scale)

    Time frame: At baseline and after 20 weeks

    Assessed with the visual analog scale

  4. Quality of life (score)

    Time frame: At baseline and after 20 weeks

    Assessed with the short form 36 questionaire

  5. Work ability index (score)

    Time frame: At baseline and afetr 20 weeks

    Assessed with the WAI questionaire

  6. Physical activity (score)

    Time frame: At baseline and after 20 weeks

    Assessed with the "Freiburger activity questionaire"

  7. Fat mass and fat-free mass (kg)

    Time frame: At baseline and after 20 weeks

    Assessed with Bio Impedance Analysis

  8. 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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Jan 7, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.