Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415464
Other study ID # 630-1/2016-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date September 30, 2018

Study information

Verified date February 2023
Source University of Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - no major injuries that would require more than 4 weeks to recover upon entry into the study - age >18 y - finished initial Army training

Study Design


Intervention

Other:
Exercise
neuromuscular training

Locations

Country Name City State
Slovenia University in Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

Kovcan B, Vodicar J, Simenko J, Videmsek M, Pori P, Vedran H. Retrospective and Cross-sectional Analysis of Physical Training-Related Musculoskeletal Injuries in Slovenian Armed Forces. Mil Med. 2019 Jan 1;184(1-2):e195-e199. doi: 10.1093/milmed/usy156. No abstract available. Erratum In: Mil Med. 2019 Mar 1;184(3-4):111. — View Citation

Kozinc Z, Sarabon N, Kovcan B, Simenko J, Pori P, Vodicar J, Hadzic V. Effects of 12-week full body resistance exercise on vertical jumping with and without military equipment in Slovenian Armed Forces. BMJ Mil Health. 2021 Sep 7:bmjmilitary-2021-001899. — View Citation

Simenko J, Kovcan B, Pori P, Vodicar J, Vodicar M, Hadzic V. The Relationship Between Army Physical Fitness and Functional Capacities in Infantry Members of the Slovenian Armed Forces. J Strength Cond Res. 2021 Dec 1;35(12):3506-3512. doi: 10.1519/JSC.000 — View Citation

Vodicar M, Kovcan B, Pori P, Vodicar J, Simenko J, Karpljuk D, Markovic G, Hadzic V. Regular strength training and baseline fitness in overweight infantry members of Slovenian Armed Forces. BMJ Mil Health. 2022 Apr;168(2):141-145. doi: 10.1136/bmjmilitary — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Soldiers With Ankle and Knee Injuries Percentage of soldiers with ankle and knee injuries during the study period. 1 year
Secondary Vertical Jump Performance jump height in countermovement jump 15 weeks
Secondary Pull-ups Performance number of overhand pull-ups in one minute 15 weeks
Secondary Hamstring Repetitive Strength Number of single leg raises on the 60 cm box 15 weeks
See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.