NCT01401842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 25, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

June 15, 2011

Results QC Date

May 5, 2015

Last Update Submit

May 22, 2015

Conditions

Lower Back Injury

Keywords

low back muscular strength and endurance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Isometric Core Muscular Endurance at 11 Weeks

    11 weeks

  • Dynamic Lumbar Extension Muscular Endurance at 11 Weeks

    11 weeks

Study Arms (2)

Strengthening Exercise

EXPERIMENTAL

Lumbar ext. high intensity progressive resistance exercise

Other: Lumbar ext. high intensity progressive resistance exercise

Stabilization Exercise

ACTIVE COMPARATOR

Low intensity core stabilization exercise

Other: Low intensity core stabilization exercise

Interventions

Lumbar ext. high intensity progressive resistance exerciseOTHER

1 active set of 1 exercise, 1x/week, 11 weeks

Strengthening Exercise
Low intensity core stabilization exerciseOTHER

1 set of 5 exercises, 1x/week, 11 weeks

Stabilization Exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Florida

Tampa, Florida, 33612, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • 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.

    PMID: 27849497DERIVED

Results Point of Contact

Title
John M. Mayer, DC, PhD / Study Director
Organization
University of South Florida
jmayer2@health.usf.edu
813-974-3818

Study Officials

  • William S Quillen, PT,DPT,PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • John M Mayer, DC,PhD

    University of South Florida

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean & Professor

Study Record Dates

First Submitted

June 15, 2011

First Posted

July 25, 2011

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

March 1, 2015

Last Updated

May 25, 2015

Results First Posted

May 25, 2015

Record last verified: 2015-05

Locations

US(2)