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Reduction of Risk for Low Back Injury in Theater of Operations

This study has been completed.
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: May 22, 2015
Last verified: May 2015
Results First Received: May 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Lower Back Injury
Interventions: Other: Lumbar ext. high intensity progressive resistance exercise
Other: Low intensity core stabilization exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment, enrollment, baseline assessments, and randomization procedures were completed during June 2012 through May 2013 at Fort Sam Houston, TX.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Strengthening Exercise Lumbar ext. high intensity progressive resistance exercise
Stabilization Exercise Low intensity core stabilization exercise

Participant Flow:   Overall Study
    Strengthening Exercise   Stabilization Exercise
STARTED   298   284 
COMPLETED   230   217 
NOT COMPLETED   68   67 
Withdrawal by Subject                3                2 
academic reason                4                1 
changed companies                20                34 
discharged from US Army                3                4 
invalid follow-up strength data                1                4 
on profile                9                5 
other/unknown                28                17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants who were deemed eligible, completed baseline assessments, and were randomized.

Reporting Groups
  Description
Strengthening Exercise Lumbar ext. high intensity progressive resistance exercise
Stabilization Exercise Low intensity core stabilization exercise
Total Total of all reporting groups

Baseline Measures
   Strengthening Exercise   Stabilization Exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 298   284   582 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.8  (3.8)   21.5  (3.6)   21.7  (3.7) 
Gender 
[Units: Participants]
     
Female   67   68   135 
Male   231   216   447 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian   3   5   8 
American Indian, Asian, Hispanic, White/Cau   1   0   1 
American Indian, Black/African American, White/Cau   1   0   1 
American Indian, White or Caucasian   3   2   5 
Asian   12   14   26 
Asian, Black/African American, Hispanic, White/Cau   1   0   1 
Asian, Black or African American, Other   1   0   1 
Asian, Hispanic   0   1   1 
Asian, Pacific Islander   0   1   1 
Asian, White or Caucasian   3   1   4 
Black or African American   27   26   53 
Black or African American, Hispanic   1   0   1 
Black or African American, White or Caucasian   0   3   3 
Hispanic   46   41   87 
Hispanic, White or Caucasian   2   2   4 
Other/unknown   6   10   16 
Other, White or Caucasian   1   0   1 
Pacific Islander   2   4   6 
Pacific Islander, White or Caucasian   0   2   2 
White or Caucasian   188   172   360 
Region of Enrollment [1] 
[Units: Participants]
     
United States   298   284   582 
[1] All participants were enrolled from Fort Sam Houston, TX, USA
Isometric Lumbar Extension Muscular Strength [1] 
[Units: Nm]
Mean (Standard Deviation)
 275.4  (87.0)   271.7  (92.8)   273.7  (89.9) 
[1] Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer
Isometric Core Muscular Endurance [1] 
[Units: Seconds]
Mean (Standard Deviation)
 169.0  (62.4)   172.8  (64.1)   170.8  (63.2) 
[1] Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test). Strengthening Exercise: n = 296; Stabilization Exercise: n = 279.
Dynamic Lumbar Extension Muscular Endurance [1] 
[Units: Repetitions]
Mean (Standard Deviation)
 21.8  (7.7)   22.0  (8.0)   21.9  (7.9) 
[1] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Isometric Lumbar Extension Muscular Strength at 11 Weeks   [ Time Frame: 11 weeks ]

2.  Secondary:   Isometric Core Muscular Endurance at 11 Weeks   [ Time Frame: 11 weeks ]

3.  Secondary:   Dynamic Lumbar Extension Muscular Endurance at 11 Weeks   [ Time Frame: 11 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John M. Mayer, DC, PhD / Study Director
Organization: University of South Florida
phone: 813-974-3818
e-mail: jmayer2@health.usf.edu



Responsible Party: William Quillen, University of South Florida
ClinicalTrials.gov Identifier: NCT01401842     History of Changes
Other Study ID Numbers: 10193004
Study First Received: June 15, 2011
Results First Received: May 5, 2015
Last Updated: May 22, 2015