Reduction of Risk for Low Back Injury in Theater of Operations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance

NCT06396247

Mobility Limitation

RECRUITING PHASE2/PHASE3

Minimal Equipment Training Approach to Improve Warfighter Performance

NCT05003778

Healthy Military Operations

COMPLETED NA

Effects of Low-Intensity Blood Flow Restriction Training in Normoxia and Hypoxia Conditions

NCT06171841

Hypoxia, Altitude Blood Flow Restriction Resistance Training

ACTIVE_NOT_RECRUITING NA

Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

NCT01216722

Liver Transplantation Resistance Training Activities of Daily Living

COMPLETED NA

Effectiveness of Blood Flow Restriction During Aerobic Cycling

NCT04808869

Exercise Intervention

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Back Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Strengthening Exercise

Lumbar ext. high intensity progressive resistance exercise

Group Type EXPERIMENTAL

Lumbar ext. high intensity progressive resistance exercise

Intervention Type OTHER

1 active set of 1 exercise, 1x/week, 11 weeks

Stabilization Exercise

Low intensity core stabilization exercise

Group Type ACTIVE_COMPARATOR

Low intensity core stabilization exercise

Intervention Type OTHER

1 set of 5 exercises, 1x/week, 11 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lumbar ext. high intensity progressive resistance exercise

1 active set of 1 exercise, 1x/week, 11 weeks

Intervention Type OTHER

Low intensity core stabilization exercise

1 set of 5 exercises, 1x/week, 11 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-35 years
* Active duty soldiers in the US Army training to become combat medics at Fort Sam Houston

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes