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| Name | Class |
|---|---|
| Brooke Army Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengthening Exercise | Experimental | Lumbar ext. high intensity progressive resistance exercise |
|
| Stabilization Exercise | Active Comparator | Low intensity core stabilization exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar ext. high intensity progressive resistance exercise | Other | 1 active set of 1 exercise, 1x/week, 11 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric Core Muscular Endurance at 11 Weeks | Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test) | 11 weeks |
| Dynamic Lumbar Extension Muscular Endurance at 11 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William S Quillen, PT,DPT,PhD | University of South Florida | Principal Investigator |
| John M Mayer, DC,PhD | University of South Florida | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | United States | ||
| Brooke Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27849497 | Derived | 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. |
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Assessed for eligibility: n = 698. Consented: n = 645. Deemed eligible to participate, completed baseline assessments for primary outcome, and randomized: n = 582. Reasons for ineligibility: declined to participate (n = 43), did not meet inclusion criteria (n = 28), and other or unknown reasons (n = 45).
Recruitment, enrollment, baseline assessments, and randomization procedures were completed during June 2012 through May 2013 at Fort Sam Houston, TX.
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| ID | Title | Description |
|---|---|---|
| FG000 | Strengthening Exercise | Lumbar ext. high intensity progressive resistance exercise |
| FG001 | Stabilization Exercise | Low intensity core stabilization exercise |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants who were deemed eligible, completed baseline assessments, and were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Strengthening Exercise | Lumbar ext. high intensity progressive resistance exercise |
| BG001 | Stabilization Exercise | Low intensity core stabilization exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Adjusted (by baseline score) isometric lumbar extension muscular strength in Nm (mean ± SE) at follow-up | Posted | Mean | Standard Error | Nm | 11 weeks |
|
Adverse event information was collected for the time frame from baseline assessments through the 11-week intervention period through the follow-up assessments, up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strengthening Exercise | Lumbar ext. high intensity progressive resistance exercise |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Low back muscle soreness following baseline lumbar extension strength test (stabilization exercise, n = 1), or following intervention session (strengthening exercise, n = 3). Mild. Related to study procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John M. Mayer, DC, PhD / Study Director | University of South Florida | 813-974-3818 | jmayer2@health.usf.edu |
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| Low intensity core stabilization exercise | Other | 1 set of 5 exercises, 1x/week, 11 weeks |
|
Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer
| 11 weeks |
| Fort Sam Houston |
| Texas |
| 78234 |
| United States |
| changed companies |
|
| discharged from US Army |
|
| invalid follow-up strength data |
|
| on profile |
|
| other/unknown |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | All participants were enrolled from Fort Sam Houston, TX, USA | Number | participants |
|
| Isometric Lumbar Extension Muscular Strength | Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer | Mean | Standard Deviation | Nm |
|
| Isometric Core Muscular Endurance | Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test). Strengthening Exercise: n = 296; Stabilization Exercise: n = 279. | Mean | Standard Deviation | seconds |
|
| Dynamic Lumbar Extension Muscular Endurance | Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer. Strengthening Exercise: n = 285; Stabilization Exercise: n = 271. | Mean | Standard Deviation | repetitions |
|
| Units | Counts |
|---|---|
| Participants |
|
|
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| Secondary | Isometric Core Muscular Endurance at 11 Weeks | Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test) | Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for primary outcome (n = 4 stabilization arm; n = 1 strengthening arm), and incomplete data for this outcome (n = 1 stabilization arm). | Posted | Mean | Standard Error | seconds | 11 weeks |
|
|
|
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| Secondary | 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 | Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for this outcome (n = 11 stabilization arm; n = 18 strengthening arm). | Posted | Mean | Standard Error | repetitions | 11 weeks |
|
|
|
|
| 0 |
| 298 |
| 6 |
| 298 |
| EG001 | Stabilization Exercise | Low intensity core stabilization exercise | 0 | 284 | 1 | 284 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Lower extremity pain during Advanced Infantry Training and aggravated by study intervention (strengthening exercise, n = 1). Mild. Initial incident: Unrelated to study procedures. Aggravation: related to study procedures. |
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| Musculoskeletal and connective tissue disorder - other: abdominal injury | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Mild. Unrelated to study procedures. |
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| Musculoskeletal and connective tissue disorder - other: groin injury | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Mild. Unrelated to study procedures. |
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