Trial Outcomes & Findings for Reduction of Risk for Low Back Injury in Theater of Operations (NCT NCT01401842)
NCT ID: NCT01401842
Last Updated: 2015-05-25
Results Overview
Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
582 participants
Primary outcome timeframe
11 weeks
Results posted on
2015-05-25
Participant Flow
Recruitment, enrollment, baseline assessments, and randomization procedures were completed during June 2012 through May 2013 at Fort Sam Houston, TX.
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).
Participant milestones
| Measure |
Strengthening Exercise
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
Low intensity core stabilization exercise
|
|---|---|---|
|
Overall Study
STARTED
|
298
|
284
|
|
Overall Study
COMPLETED
|
230
|
217
|
|
Overall Study
NOT COMPLETED
|
68
|
67
|
Reasons for withdrawal
| Measure |
Strengthening Exercise
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
Low intensity core stabilization exercise
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
academic reason
|
4
|
1
|
|
Overall Study
changed companies
|
20
|
34
|
|
Overall Study
discharged from US Army
|
3
|
4
|
|
Overall Study
invalid follow-up strength data
|
1
|
4
|
|
Overall Study
on profile
|
9
|
5
|
|
Overall Study
other/unknown
|
28
|
17
|
Baseline Characteristics
Reduction of Risk for Low Back Injury in Theater of Operations
Baseline characteristics by cohort
| Measure |
Strengthening Exercise
n=298 Participants
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
n=284 Participants
Low intensity core stabilization exercise
|
Total
n=582 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.8 years
STANDARD_DEVIATION 3.8 • n=93 Participants
|
21.5 years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
21.7 years
STANDARD_DEVIATION 3.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
231 Participants
n=93 Participants
|
216 Participants
n=4 Participants
|
447 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
3 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian, Asian, Hispanic, White/Cau
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian, Black/African American, White/Cau
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian, White or Caucasian
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=93 Participants
|
14 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Black/African American, Hispanic, White/Cau
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Black or African American, Other
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Hispanic
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, White or Caucasian
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 participants
n=93 Participants
|
26 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American, Hispanic
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American, White or Caucasian
|
0 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
46 participants
n=93 Participants
|
41 participants
n=4 Participants
|
87 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic, White or Caucasian
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other/unknown
|
6 participants
n=93 Participants
|
10 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other, White or Caucasian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander, White or Caucasian
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
188 participants
n=93 Participants
|
172 participants
n=4 Participants
|
360 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
298 participants
n=93 Participants
|
284 participants
n=4 Participants
|
582 participants
n=27 Participants
|
|
Isometric Lumbar Extension Muscular Strength
|
275.4 Nm
STANDARD_DEVIATION 87.0 • n=93 Participants
|
271.7 Nm
STANDARD_DEVIATION 92.8 • n=4 Participants
|
273.7 Nm
STANDARD_DEVIATION 89.9 • n=27 Participants
|
|
Isometric Core Muscular Endurance
|
169.0 seconds
STANDARD_DEVIATION 62.4 • n=93 Participants
|
172.8 seconds
STANDARD_DEVIATION 64.1 • n=4 Participants
|
170.8 seconds
STANDARD_DEVIATION 63.2 • n=27 Participants
|
|
Dynamic Lumbar Extension Muscular Endurance
|
21.8 repetitions
STANDARD_DEVIATION 7.7 • n=93 Participants
|
22.0 repetitions
STANDARD_DEVIATION 8.0 • n=4 Participants
|
21.9 repetitions
STANDARD_DEVIATION 7.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: 11 weeksPopulation: Adjusted (by baseline score) isometric lumbar extension muscular strength in Nm (mean ± SE) at follow-up
Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer
Outcome measures
| Measure |
Strengthening Exercise
n=230 Participants
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
n=217 Participants
Low intensity core stabilization exercise
|
|---|---|---|
|
Isometric Lumbar Extension Muscular Strength at 11 Weeks
|
310.2 Nm
Standard Error 6.1
|
282.7 Nm
Standard Error 6.1
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: 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).
Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)
Outcome measures
| Measure |
Strengthening Exercise
n=231 Participants
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
n=220 Participants
Low intensity core stabilization exercise
|
|---|---|---|
|
Isometric Core Muscular Endurance at 11 Weeks
|
161.4 seconds
Standard Error 7.2
|
160.2 seconds
Standard Error 7.2
|
SECONDARY outcome
Timeframe: 11 weeksPopulation: 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).
Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer
Outcome measures
| Measure |
Strengthening Exercise
n=212 Participants
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
n=206 Participants
Low intensity core stabilization exercise
|
|---|---|---|
|
Dynamic Lumbar Extension Muscular Endurance at 11 Weeks
|
24.6 repetitions
Standard Error 1.0
|
21.9 repetitions
Standard Error 1.0
|
Adverse Events
Strengthening Exercise
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Stabilization Exercise
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Strengthening Exercise
n=298 participants at risk
Lumbar ext. high intensity progressive resistance exercise
|
Stabilization Exercise
n=284 participants at risk
Low intensity core stabilization exercise
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
3/298 • Number of events 3 • 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.
|
0.35%
1/284 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
1/298 • Number of events 1 • 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.
|
0.00%
0/284 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other: abdominal injury
|
0.34%
1/298 • Number of events 1 • 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.
|
0.00%
0/284 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other: groin injury
|
0.34%
1/298 • Number of events 1 • 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.
|
0.00%
0/284 • 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.
|
Additional Information
John M. Mayer, DC, PhD / Study Director
University of South Florida
Phone: 813-974-3818
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place