Reduction of Risk for Low Back Injury in Theater of Operations

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
William Quillen, University of South Florida
ClinicalTrials.gov Identifier:
NCT01401842
First received: June 15, 2011
Last updated: October 7, 2013
Last verified: October 2013
  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 12-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: High intensity progressive resistance exercise on specialized equipment for the lumbar extensor muscles
Other: Low intensity stability exercises for the core muscles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of South Florida:

Primary Outcome Measures:
  • Change from baseline in Isometric lumbar extensor muscular strength at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Isometric lumbar extensor muscular strength (torque) as assessed by a validated physical performance test on the lumbar dynamometer.


Secondary Outcome Measures:
  • Change from baseline in endurance as measured through physical performance tests at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Secondary measures include dynamic lumbar extension endurance, isometric trunk extension endurance, dynamic trunk extension endurance, and isometric core stability muscular endurance by validated physical performance tests.


Estimated Enrollment: 1140
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strengthening Exercise
Strengthening exercise.
Other: High intensity progressive resistance exercise on specialized equipment for the lumbar extensor muscles
1 set, 1x/week, 12 weeks
Active Comparator: Stabilization exercise
Stabilization exercise.
Other: Low intensity stability exercises for the core muscles
1 set, 1x/week, 12 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 12-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 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 control group will perform 5 minutes of low intensity core stabilization exercises on the floor. Interventions will be carried out 1X/week for 12 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 12-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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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,FACSM University of South Florida
Study Director: John M Mayer, DC,PhD University of South Florida
  More Information

No publications provided

Responsible Party: William Quillen, Associate Dean & Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01401842     History of Changes
Other Study ID Numbers: 10193004
Study First Received: June 15, 2011
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Back Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014