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Exercise and Low Back Pain

Primary Purpose

Healthy Volunteers With and Without Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Volunteers With and Without Chronic Low Back Pain

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hannover Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Controls

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2014
Last Updated
February 22, 2017
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02029131
Brief Title
Exercise and Low Back Pain
Official Title
Effects of a Home-based Exercise Program on Low Back Pain in Employees
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers With and Without Chronic Low Back Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Controls
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Back strength (kg)
Description
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
Time Frame
At baseline and after 20 weeks
Secondary Outcome Measure Information:
Title
Strenght at lateral flexion of the trunk (kg)
Description
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
Time Frame
At baseline and after 20 weeks
Title
Oswestry Low Back Pain Disability Score
Description
Assessed with the Oswestry Low Back Pain Disability questionaire
Time Frame
At baseline and after 20 weeks
Title
Pain (scale)
Description
Assessed with the visual analog scale
Time Frame
At baseline and after 20 weeks
Title
Quality of life (score)
Description
Assessed with the short form 36 questionaire
Time Frame
At baseline and after 20 weeks
Title
Work ability index (score)
Description
Assessed with the WAI questionaire
Time Frame
At baseline and afetr 20 weeks
Title
Physical activity (score)
Description
Assessed with the "Freiburger activity questionaire"
Time Frame
At baseline and after 20 weeks
Title
Fat mass and fat-free mass (kg)
Description
Assessed with Bio Impedance Analysis
Time Frame
At baseline and after 20 weeks
Title
sick days (numbers)
Description
sick days at work will be assessed for the 20 weeks of the active intervention and the whole year the intervention is conducted
Time Frame
At baseline and after 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35144658
Citation
Bayerle P, Kerling A, Kuck M, Rolff S, Boeck HT, Sundermeier T, Ensslen R, Tegtbur U, Lauenstein D, Bothig D, Bara C, Hanke A, Terkamp C, Haverich A, Stiesch M, de Zwaan M, Haufe S, Nachbar L. Effectiveness of wearable devices as a support strategy for maintaining physical activity after a structured exercise intervention for employees with metabolic syndrome: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Feb 10;14(1):24. doi: 10.1186/s13102-022-00409-1.
Results Reference
derived

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Exercise and Low Back Pain

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