Reduction of Risk for Low Back Injury in Theater of Operations
|ClinicalTrials.gov Identifier: NCT01401842|
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : May 25, 2015
Last Update Posted : May 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lower Back Injury||Other: Lumbar ext. high intensity progressive resistance exercise Other: Low intensity core stabilization exercise||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||582 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reduction of Risk for Low Back Injury in Theater of Operations|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||March 2015|
Experimental: Strengthening Exercise
Lumbar ext. high intensity progressive resistance exercise
Other: Lumbar ext. high intensity progressive resistance exercise
1 active set of 1 exercise, 1x/week, 11 weeks
Active Comparator: Stabilization Exercise
Low intensity core stabilization exercise
Other: Low intensity core stabilization exercise
1 set of 5 exercises, 1x/week, 11 weeks
- 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
- Isometric Core Muscular Endurance at 11 Weeks [ Time Frame: 11 weeks ]Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)
- Dynamic Lumbar Extension Muscular Endurance at 11 Weeks [ Time Frame: 11 weeks ]Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401842
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|Principal Investigator:||William S Quillen, PT,DPT,PhD||University of South Florida|
|Study Director:||John M Mayer, DC,PhD||University of South Florida|