Lower Back InjuryNCT01401842
Reduction of Risk for Low Back Injury in Theater of Operations
A study testing Lumbar ext. high intensity progressive resistance exercise and Low intensity core stabilization exercise in people with Lower Back Injury, run by University of South Florida at 2 sites in United States.
Trial summary
The investigators will conduct a controlled clinical trial with U.S. Army soldiers training to become combat medics. The purpose of this study is to determine if a 11-week, high intensity exercise program targeting the low back muscles using specialized equipment will result in a 25% increase in low back muscular… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Injury
- What is being tested?
- Lumbar ext. high intensity progressive resistance exercise and Low intensity core stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 years
- Active duty soldiers in the US Army training to become combat medics at Fort Sam Houston
Who cannot join
- Cardiovascular contraindications to resistance exercise as identified by history and physical examination
- Orthopedic contraindications to resistance exercise as identified by history and physical examination
- History of systemic inflammatory disease or spinal surgery
- Low back pain intensity > "mild"
- Disability >= 50% on the Roland Morris Disability Questionnaire
- Currently receiving care for spinal pain disorder/injury
Show all 15Show fewer
- Currently disabled due to spinal pain disorder/injury
- Currently diagnosed with or receiving treatment for a psychological or psychiatric disorder
- Currently performing progressive resistance exercises for the lumbar extensor muscles other than those included in standard for military fitness programs
- Active workers' compensation or personal injury case
- Pregnant
- Simultaneously enrolled in another biomedical clinical trial
- Drug or alcohol abuse within the past year
- Any other condition, which in the opinion of the investigators or military medical authority, would put the candidate at increased safety risk or otherwise make the candidate unsuitable for this study
- Unable or unwilling to complete the study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
University of South Florida
Tampa, Florida, 33612
About this study
The investigators will conduct a controlled clinical trial with U.S. Army soldiers training to become combat medics. The purpose of this study is to determine if a 11-week, high intensity exercise program targeting the low back muscles using specialized equipment will result in a 25% increase in low back muscular strength and endurance compared with a lower intensity general core stability exercise.
Read the detailed description
Background Low back injury is responsible for the largest percentage of non-battle injuries in the theater of operations and is a large contributor to non-expiration of active service attrition in the US Armed Forces. Weakness and poor endurance of the back muscles are associated with low back injury. Targeted, high intensity exercise approaches using specialized equipment to develop the strength and endurance of the "weak link" muscle group (the lumbar extensors) have been shown to reduce risk for low back injury in high-risk civilian workers, but have not been widely implemented in military settings.
Objective/Hypothesis Specific Aim: In a controlled clinical trial, the investigators will assess the effectiveness of a high intensity progressive resistance exercise training program targeting the lumbar extensors to improve lumbar extensor muscular strength and endurance in US Army soldiers.
Hypothesis: A high intensity progressive resistance exercise for the lumbar extensors will result in a 25% increase in lumbar extensor muscular strength and endurance compared with control following the 11-week intervention.
Study Design A mixed methods, two-arm, controlled clinical trial with cluster randomization will be conducted. The sampling frame will be soldiers training to become combat medics from one domestic US Army base. Soldiers will be randomly assigned (by platoon) to one of two interventions - experimental or control. All participants at a given platoon will receive the same intervention and all interventions will be carried out at the US Army base, in addition to the soldiers' usual physical fitness training program. Participants randomized to the experimental group (strengthening exercise) will perform lumbar extensor muscle progressive resistance exercise using standardized protocols. Exercise training will consist of 1 set of high intensity progressive resistance exercise for lumbar extensors on specialized equipment. Participants in the active comparator control group (stabilization exercise) will perform 5 minutes of low intensity core stabilization exercises on the floor. Interventions will be carried out 1X/week for 11 weeks. Outcome measures that will be utilized to test the hypothesis of Aim 1 include validated physical fitness tests for lumbar extension muscular strength and endurance. Fitness tests will be conducted at baseline and following the 11-week intervention period.
Relevance Soldiers preparing for deployment are in need of advanced technology to help improve and optimize the functional capacity of the lumbar extensor muscles. Assuming positive results from this study and confirmatory trials, implementation of this targeted exercise protocol will maximize resilience in soldiers at high risk for low back injury, thereby helping them become more physically fit to counteract the extreme physical demands required in combat.
- Conditions
- Lower Back Injury
- Being tested
- Lumbar ext. high intensity progressive resistance exercise, Low intensity core stabilization exercise
- Keywords
- low back muscular strength and endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar ext. high intensity progressive resistance exerciseOther
1 active set of 1 exercise, 1x/week, 11 weeks
Low intensity core stabilization exerciseOther
1 set of 5 exercises, 1x/week, 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| Strengthening Exercise | Experimental | Lumbar ext. high intensity progressive resistance exercise Receives: Other: Lumbar ext. high intensity progressive resistance exercise |
| Stabilization Exercise | Active comparator | Low intensity core stabilization exercise Receives: Other: Low intensity core stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Lumbar Extension Muscular Strength at 11 Weeks
Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer
Measured: 11 weeks
Secondary outcomes (2)
Isometric Core Muscular Endurance at 11 Weeks
Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)
Measured: 11 weeks
Dynamic Lumbar Extension Muscular Endurance at 11 Weeks
Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back InjuryStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center
- Responsible party
- Principal investigator, William Quillen, University of South Florida
- Investigators
- William S Quillen, PT,DPT,PhD, Principal investigator, University of South FloridaJohn M Mayer, DC,PhD, Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401842
- Sponsor's protocol ID
- 10193004
- Status last verified
- May 2015
- First submitted
- 15 Jun 2011
- Last updated
- 25 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mayer JM, Childs JD, Neilson BD, Chen H, Koppenhaver SL, Quillen WS. Effect of Lumbar Progressive Resistance Exercise on Lumbar Muscular Strength and Core Muscular Endurance in Soldiers. Mil Med. 2016 Nov;181(11):e1615-e1622. doi: 10.7205/MILMED-D-15-00543.
PubMed 27849497
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Risk for Low Back Injury in Theater of Operations
- ClinicalTrials.gov ID
- NCT01401842
- Acronym / sponsor ID
- 10193004
- Conditions
- Lower Back Injury
- Keywords
- low back muscular strength and endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 25 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a controlled clinical trial with U.S. Army soldiers training to become combat medics. The purpose of this study is to determine if a 11-week, high intensity exercise program targeting the low back muscles using specialized equipment will result in a 25% increase in low back muscular strength and endurance compared with a lower intensity general core stability exercise.
Detailed description
Background Low back injury is responsible for the largest percentage of non-battle injuries in the theater of operations and is a large contributor to non-expiration of active service attrition in the US Armed Forces. Weakness and poor endurance of the back muscles are associated with low back injury. Targeted, high intensity exercise approaches using specialized equipment to develop the strength and endurance of the "weak link" muscle group (the lumbar extensors) have been shown to reduce risk for low back injury in high-risk civilian workers, but have not been widely implemented in military settings.
Objective/Hypothesis Specific Aim: In a controlled clinical trial, the investigators will assess the effectiveness of a high intensity progressive resistance exercise training program targeting the lumbar extensors to improve lumbar extensor muscular strength and endurance in US Army soldiers.
Hypothesis: A high intensity progressive resistance exercise for the lumbar extensors will result in a 25% increase in lumbar extensor muscular strength and endurance compared with control following the 11-week intervention.
Study Design A mixed methods, two-arm, controlled clinical trial with cluster randomization will be conducted. The sampling frame will be soldiers training to become combat medics from one domestic US Army base. Soldiers will be randomly assigned (by platoon) to one of two interventions - experimental or control. All participants at a given platoon will receive the same intervention and all interventions will be carried out at the US Army base, in addition to the soldiers' usual physical fitness training program. Participants randomized to the experimental group (strengthening exercise) will perform lumbar extensor muscle progressive resistance exercise using standardized protocols. Exercise training will consist of 1 set of high intensity progressive resistance exercise for lumbar extensors on specialized equipment. Participants in the active comparator control group (stabilization exercise) will perform 5 minutes of low intensity core stabilization exercises on the floor. Interventions will be carried out 1X/week for 11 weeks. Outcome measures that will be utilized to test the hypothesis of Aim 1 include validated physical fitness tests for lumbar extension muscular strength and endurance. Fitness tests will be conducted at baseline and following the 11-week intervention period.
Relevance Soldiers preparing for deployment are in need of advanced technology to help improve and optimize the functional capacity of the lumbar extensor muscles. Assuming positive results from this study and confirmatory trials, implementation of this targeted exercise protocol will maximize resilience in soldiers at high risk for low back injury, thereby helping them become more physically fit to counteract the extreme physical demands required in combat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening Exercise | Experimental | Other: Lumbar ext. high intensity progressive resistance exerciseLumbar ext. high intensity progressive resistance exercise |
| Stabilization Exercise | Active comparator | Other: Low intensity core stabilization exerciseLow intensity core stabilization exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-35 years
- Active duty soldiers in the US Army training to become combat medics at Fort Sam Houston
Key exclusion criteria (15 listed)
- Cardiovascular contraindications to resistance exercise as identified by history and physical examination
- Orthopedic contraindications to resistance exercise as identified by history and physical examination
- History of systemic inflammatory disease or spinal surgery
- Low back pain intensity > "mild"
- Disability >= 50% on the Roland Morris Disability Questionnaire
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 |
|---|---|---|
| Lumbar ext. high intensity progressive resistance exercise1 active set of 1 exercise, 1x/week, 11 weeks | Other | Strengthening Exercise |
| Low intensity core stabilization exercise1 set of 5 exercises, 1x/week, 11 weeks | Other | Stabilization Exercise |
Primary outcome
Isometric Lumbar Extension Muscular Strength at 11 Weeks
Time frame: 11 weeks
Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer
2 secondary outcomes
Isometric Core Muscular Endurance at 11 Weeks
Time frame: 11 weeks
Dynamic Lumbar Extension Muscular Endurance at 11 Weeks
Time frame: 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27849497Mayer JM, Childs JD, Neilson BD, Chen H, Koppenhaver SL, Quillen WS. Effect of Lumbar Progressive Resistance Exercise on Lumbar Muscular Strength and Core Muscular Endurance in Soldiers. Mil Med. 2016 Nov;181(11):e1615-e1622. doi: 10.7205/MILMED-D-15-00543.
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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.
William S Quillen, PT,DPT,PhD principal investigator
University of South Florida
John M Mayer, DC,PhD study director
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar ext. high intensity progressive resistance exercise and Low intensity core stabilization exercise in people with Lower Back Injury, run by University of South Florida at 2 sites in United States.
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 15 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Isometric Lumbar Extension Muscular Strength at 11 Weeks (time frame: 11 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 NCT01401842, 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 25 May 2015.