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Reduction of Risk for Low Back Injury in Theater of Operations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401842
First Posted: July 25, 2011
Last Update Posted: May 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
William Quillen, University of South Florida
  Purpose
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.

Condition Intervention
Lower Back Injury Other: Lumbar ext. high intensity progressive resistance exercise Other: Low intensity core stabilization exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Risk for Low Back Injury in Theater of Operations

Resource links provided by NLM:


Further study details as provided by William Quillen, University of South Florida:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 582
Study Start Date: June 2012
Study Completion Date: March 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401842


Locations
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
Sponsors and Collaborators
University of South Florida
Brooke Army Medical Center
Investigators
Principal Investigator: William S Quillen, PT,DPT,PhD University of South Florida
Study Director: John M Mayer, DC,PhD University of South Florida
  More Information

Responsible Party: William Quillen, Associate Dean & Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01401842     History of Changes
Other Study ID Numbers: 10193004
First Submitted: June 15, 2011
First Posted: July 25, 2011
Results First Submitted: May 5, 2015
Results First Posted: May 25, 2015
Last Update Posted: May 25, 2015
Last Verified: May 2015

Keywords provided by William Quillen, University of South Florida:
low back muscular strength and endurance

Additional relevant MeSH terms:
Wounds and Injuries
Back Injuries