Healthy Volunteers With and Without Chronic Low Back PainNCT02029131
Exercise and Low Back Pain
A study testing Exercise in people with Healthy Volunteers With and Without Chronic Low Back Pain, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers With and Without Chronic Low Back Pain
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women
- age between 18 and 67 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back strength (kg)
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
Measured: At baseline and after 20 weeks
Secondary outcomes (8)
Strenght at lateral flexion of the trunk (kg)
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
Measured: At baseline and after 20 weeks
Oswestry Low Back Pain Disability Score
Assessed with the Oswestry Low Back Pain Disability questionaire
Measured: At baseline and after 20 weeks
Pain (scale)
Assessed with the visual analog scale
Measured: At baseline and after 20 weeks
Quality of life (score)
Assessed with the short form 36 questionaire
Measured: At baseline and after 20 weeks
Work ability index (score)
Assessed with the WAI questionaire
Measured: At baseline and afetr 20 weeks
Physical activity (score)
Assessed with the "Freiburger activity questionaire"
Measured: At baseline and after 20 weeks
Fat mass and fat-free mass (kg)
Assessed with Bio Impedance Analysis
Measured: At baseline and after 20 weeks
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
Measured: At baseline and after 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers With and Without Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Haufe, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029131
- Sponsor's protocol ID
- SpoMed Low Back
- Status last verified
- Feb 2017
- First submitted
- 3 Jan 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35144658
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Exercise Program on Low Back Pain in Employees
- ClinicalTrials.gov ID
- NCT02029131
- Acronym / sponsor ID
- SpoMed Low Back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Controls | No intervention | – |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men and women
- age between 18 and 67 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEducated 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. | Behavioural | Exercise |
Primary outcome
Back strength (kg)
Time frame: At baseline and after 20 weeks
Assessed with the back-check 607 (Dr. WOLFF Sports and Prevention)
8 secondary outcomes
Strenght at lateral flexion of the trunk (kg)
Time frame: At baseline and after 20 weeks
Oswestry Low Back Pain Disability Score
Time frame: At baseline and after 20 weeks
Pain (scale)
Time frame: At baseline and after 20 weeks
Quality of life (score)
Time frame: At baseline and after 20 weeks
Work ability index (score)
Time frame: At baseline and afetr 20 weeks
Physical activity (score)
Time frame: At baseline and after 20 weeks
Fat mass and fat-free mass (kg)
Time frame: At baseline and after 20 weeks
sick days (numbers)
Time frame: At baseline and after 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 35144658Bayerle 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy Volunteers With and Without Chronic Low Back Pain, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back strength (kg) (time frame: At baseline and after 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.