Lower Back Injury Clinical Trial
Official title:
Reduction of Risk for Low Back Injury in Theater of Operations
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05834959 -
Implementation of a Fitness Education and Training Program to Support Safe Patient Handling and Safe Lifting
|
N/A |