Healthy Volunteers With and Without Chronic Low Back Pain Clinical Trial
Official title:
Effects of a Home-based Exercise Program on Low Back Pain in Employees
| Verified date | February 2017 |
| Source | Hannover Medical School |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 226 |
| Est. completion date | February 2017 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 67 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Hannover Medical School | Hannover | Lower Saxony |
| Lead Sponsor | Collaborator |
|---|---|
| Hannover Medical School |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Back strength (kg) | Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention) | At baseline and after 20 weeks | |
| Secondary | Strenght at lateral flexion of the trunk (kg) | Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention) | At baseline and after 20 weeks | |
| Secondary | Oswestry Low Back Pain Disability Score | Assessed with the Oswestry Low Back Pain Disability questionaire | At baseline and after 20 weeks | |
| Secondary | Pain (scale) | Assessed with the visual analog scale | At baseline and after 20 weeks | |
| Secondary | Quality of life (score) | Assessed with the short form 36 questionaire | At baseline and after 20 weeks | |
| Secondary | Work ability index (score) | Assessed with the WAI questionaire | At baseline and afetr 20 weeks | |
| Secondary | Physical activity (score) | Assessed with the "Freiburger activity questionaire" | At baseline and after 20 weeks | |
| Secondary | Fat mass and fat-free mass (kg) | Assessed with Bio Impedance Analysis | At baseline and after 20 weeks | |
| Secondary | 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 | At baseline and after 20 weeks |