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临床试验/NCT01401842
NCT01401842已完成不适用

Reduction of Risk for Low Back Injury in Theater of Operations

University of South Florida4 个研究点 分布在 1 个国家目标入组 582 人开始时间: 2012年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
582
试验地点
4
主要终点
Isometric Lumbar Extension Muscular Strength at 11 Weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • 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

研究组 & 干预措施

Strengthening Exercise

Experimental

Lumbar ext. high intensity progressive resistance exercise

干预措施: Lumbar ext. high intensity progressive resistance exercise (Other)

Stabilization Exercise

Active Comparator

Low intensity core stabilization exercise

干预措施: Low intensity core stabilization exercise (Other)

结局指标

主要结局

Isometric Lumbar Extension Muscular Strength at 11 Weeks

时间窗: 11 weeks

Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer

次要结局

  • Isometric Core Muscular Endurance at 11 Weeks(11 weeks)
  • Dynamic Lumbar Extension Muscular Endurance at 11 Weeks(11 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Quillen

Associate Dean & Professor

University of South Florida

研究点 (4)

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