An interventional study of Exercise in Knee Injuries and Disorders, Ankle Injuries and Disorders and Low Back Pain, sponsored by University of Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by University of Ljubljana · Not applicable, Interventional, and Prevention
Physical readiness of military personnel is a cornerstone of any army, as soldiers are expected to meet high physical demands on a daily basis, and soldiers must complete one hour of physical conditioning each day. Participation in physical conditioning increases the risk of musculoskeletal injuries, and our 10-year retrospective analysis shows that 5% of soldiers sustain a sports injury during physical conditioning each year, and that ankle and knee injuries have the highest incidence rates of 25% and 20%, respectively. The primary objective of our study is to decrease the rate of ankle and knee injuries by implementing a preventive training program. The study is designed as a prospective randomized controlled trial with two arms (experimental and control).
Members of Slovenian Armed Forces - SAF (age range 18-51 years) are expected to participate in the study. Prior to recruitment the whole project will be explained to soldiers in a form of briefing during which they have the opportunity to ask and have answers to any questions concerning the nature of subsequent research. Following that explanation each participant will sign a consent form to voluntarily participate. No compensation will be given or promised for participation in a study that was approved by the Ethical board of the Faculty of Sport in Ljubljana (No. 454/2017). At the time of testing all soldiers must be free of acute injuries and should not reported any pain in musculo-skeletal system. Prior to the implementation of the preventive program all participants will underwent the set of functional testing that includes counterMovement jump (CMJ) testing, stork balANce test, pUll-ups, single leg hAmstrings bridge test, and loaded prone pLank test - MANUAL. Following initial testing a 15-week preventive training program will be implemented in experimental group, while control group will be training as usual. Following the intervention final testing will be performed to check for effectiveness of the intervention. After that a follow-up period will start during which injuries will be registered in both groups and later compared between groups (control and experimental) and within (2016-2017 injuries) groups to see if incidence rate of ankle and knee injuries has fallen.
267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.
This study's enrollment of 160 is above the median of 49 across 178 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →University of Ljubljana is the lead sponsor of 43 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
15 weeks of structured exercise intervention in the form of functional training. We have divided 15 weeks into 5 cycles each cycle lasting 3 weeks. Intervention will be administered twice per week, and each session will last 45 minutes.Each 45 minutes will be further divided into 10 minutes of functional warm-up, 30 minutes of neuromuscular training (strength, agility, balance, coordination) and 5 minutes of cool down. During the 3 week period the intensity of exercise will be increased with different form of same exercise, different number of repetitions and exercise duration.
Other: Exercise
Regular military training.
neuromuscular training
Number of Soldiers With Ankle and Knee Injuries
Percentage of soldiers with ankle and knee injuries during the study period.
Time frame: 1 year
Vertical Jump Performance
jump height in countermovement jump
Time frame: 15 weeks
Pull-ups Performance
number of overhand pull-ups in one minute
Time frame: 15 weeks
Hamstring Repetitive Strength
Number of single leg raises on the 60 cm box
Time frame: 15 weeks
Recruitment was from January to February 2017.
| Milestone | Functional Training | Regular Army Training |
|---|---|---|
| Started | 64 | 41 |
| Completed | 64 | 41 |
| Not completed | 0 | 0 |
Percentage of soldiers with ankle and knee injuries during the study period.
| Participants | Functional Training | Regular Army Training |
|---|---|---|
| Number of Soldiers With Ankle and Knee Injuries | 1 | 3 |
jump height in countermovement jump
| centimeters | Functional Training | Regular Army Training |
|---|---|---|
| Vertical Jump Performance | 35.4 ± 10.3 | 29.9 ± 10.8 |
number of overhand pull-ups in one minute
| repetitions | Functional Training | Regular Army Training |
|---|---|---|
| Pull-ups Performance | 6 ± 4 | 4 ± 4 |
Number of single leg raises on the 60 cm box
| repeitions | Functional Training | Regular Army Training |
|---|---|---|
| Hamstring Repetitive Strength | 25 ± 8 | 25 ± 7 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Functional Training | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
| Regular Military Training | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Age, Continuous(years) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Mean | 30 ± 6 | 34 ± 6 | 32 ± 6 |
| Sex: Female, Male(Participants) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 63 | 37 | 100 |
| Race (NIH/OMB)(Participants) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 64 | 41 | 105 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Single leg bridge test (right leg)(number of repetitions) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Mean | 26 ± 9 | 27 ± 7 | 27 ± 8 |
| Single leg bridge test (left leg)(number of repetitions) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Mean | 25 ± 8 | 25 ± 7 | 25 ± 8 |
| Loaded prone plank(time in seconds) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Mean | 119 ± 48 | 115 ± 50 | 117 ± 49 |
| Pull ups(number of repetitions) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Mean | 4 ± 4 | 4 ± 4 | 4 ± 4 |
| Stork balance test (right leg)(time in seconds) | Functional Training | Regular Army Training | Total |
|---|---|---|---|
| Mean | 14 ± 13 | 13 ± 14 | 14 ± 13 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2017 to primary completion in Jul 2018, 18 months.
Results were first posted in Feb 2023, 4 years 6 months after primary completion.
Of 94 non-industry interventional studies with no phase under Knee Injuries, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 51. This study's 18 months is below that.
Counting every sponsor, half of 99 studies reached it within 20 months; a quarter within 8 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Ljubljana