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Reduction of Risk for Low Back Injury in Theater of Operations

Primary Purpose

Lower Back Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar ext. high intensity progressive resistance exercise
Low intensity core stabilization exercise
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lower Back Injury focused on measuring low back muscular strength and endurance

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Florida
  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strengthening Exercise

Stabilization Exercise

Arm Description

Lumbar ext. high intensity progressive resistance exercise

Low intensity core stabilization exercise

Outcomes

Primary Outcome Measures

Isometric Lumbar Extension Muscular Strength at 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
Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)
Dynamic Lumbar Extension Muscular Endurance at 11 Weeks
Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer

Full Information

First Posted
June 15, 2011
Last Updated
May 22, 2015
Sponsor
University of South Florida
Collaborators
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01401842
Brief Title
Reduction of Risk for Low Back Injury in Theater of Operations
Official Title
Reduction of Risk for Low Back Injury in Theater of Operations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
Collaborators
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Injury
Keywords
low back muscular strength and endurance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strengthening Exercise
Arm Type
Experimental
Arm Description
Lumbar ext. high intensity progressive resistance exercise
Arm Title
Stabilization Exercise
Arm Type
Active Comparator
Arm Description
Low intensity core stabilization exercise
Intervention Type
Other
Intervention Name(s)
Lumbar ext. high intensity progressive resistance exercise
Intervention Description
1 active set of 1 exercise, 1x/week, 11 weeks
Intervention Type
Other
Intervention Name(s)
Low intensity core stabilization exercise
Intervention Description
1 set of 5 exercises, 1x/week, 11 weeks
Primary Outcome Measure Information:
Title
Isometric Lumbar Extension Muscular Strength at 11 Weeks
Description
Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Isometric Core Muscular Endurance at 11 Weeks
Description
Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)
Time Frame
11 weeks
Title
Dynamic Lumbar Extension Muscular Endurance at 11 Weeks
Description
Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William S Quillen, PT,DPT,PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John M Mayer, DC,PhD
Organizational Affiliation
University of South Florida
Official's Role
Study Director
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27849497
Citation
Mayer JM, Childs JD, Neilson BD, Chen H, Koppenhaver SL, Quillen WS. Effect of Lumbar Progressive Resistance Exercise on Lumbar Muscular Strength and Core Muscular Endurance in Soldiers. Mil Med. 2016 Nov;181(11):e1615-e1622. doi: 10.7205/MILMED-D-15-00543.
Results Reference
derived

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Reduction of Risk for Low Back Injury in Theater of Operations

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