Trial Outcomes & Findings for Prevention of Musculoskeletal Injuries in Slovenian Armed Forces (NCT NCT03415464)

NCT ID: NCT03415464

Last Updated: 2023-02-23

Results Overview

Percentage of soldiers with ankle and knee injuries during the study period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2023-02-23

Participant Flow

Recruitment was from January to February 2017.

Initially, there were 160 soldier who approved to participate in initial testing, but prior to assignment of participants to groups 55 of them has declined further participation for different reasons, so only 105 soldiers was later randomised into groups, but the completion rate after this point was 100%.

Participant milestones

Measure	Functional Training 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. Exercise: neuromuscular training	Regular Army Training Regular military training.
Overall Study STARTED	64	41
Overall Study COMPLETED	64	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Musculoskeletal Injuries in Slovenian Armed Forces

Baseline characteristics by cohort

Measure	Functional Training n=64 Participants 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 was administered twice per week, and each session lasted 45 minutes. Each 45 minutes was 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 was increased with different form of same exercise, different number of repetitions and exercise duration. Exercise: neuromuscular training	Regular Army Training n=41 Participants Regular military training.	Total n=105 Participants Total of all reporting groups
Age, Continuous	30 years STANDARD_DEVIATION 6 • n=113 Participants	34 years STANDARD_DEVIATION 6 • n=163 Participants	32 years STANDARD_DEVIATION 6 • n=160 Participants
Sex: Female, Male Female	1 Participants n=113 Participants	4 Participants n=163 Participants	5 Participants n=160 Participants
Sex: Female, Male Male	63 Participants n=113 Participants	37 Participants n=163 Participants	100 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) White	64 Participants n=113 Participants	41 Participants n=163 Participants	105 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Single leg bridge test (right leg)	26 number of repetitions STANDARD_DEVIATION 9 • n=113 Participants	27 number of repetitions STANDARD_DEVIATION 7 • n=163 Participants	27 number of repetitions STANDARD_DEVIATION 8 • n=160 Participants
Single leg bridge test (left leg)	25 number of repetitions STANDARD_DEVIATION 8 • n=113 Participants	25 number of repetitions STANDARD_DEVIATION 7 • n=163 Participants	25 number of repetitions STANDARD_DEVIATION 8 • n=160 Participants
Loaded prone plank	119 time in seconds STANDARD_DEVIATION 48 • n=113 Participants	115 time in seconds STANDARD_DEVIATION 50 • n=163 Participants	117 time in seconds STANDARD_DEVIATION 49 • n=160 Participants
Pull ups	4 number of repetitions STANDARD_DEVIATION 4 • n=113 Participants	4 number of repetitions STANDARD_DEVIATION 4 • n=163 Participants	4 number of repetitions STANDARD_DEVIATION 4 • n=160 Participants
Stork balance test (right leg)	14 time in seconds STANDARD_DEVIATION 13 • n=113 Participants	13 time in seconds STANDARD_DEVIATION 14 • n=163 Participants	14 time in seconds STANDARD_DEVIATION 13 • n=160 Participants
Stork balance test (left leg)	14 time seconds STANDARD_DEVIATION 13 • n=113 Participants	13 time seconds STANDARD_DEVIATION 13 • n=163 Participants	14 time seconds STANDARD_DEVIATION 13 • n=160 Participants
Countermovement jump height	28.3 centimeters STANDARD_DEVIATION 3.9 • n=113 Participants	26.0 centimeters STANDARD_DEVIATION 4.9 • n=163 Participants	27.4 centimeters STANDARD_DEVIATION 4.5 • n=160 Participants
Loaded countermovement jump height	25.2 centimeters STANDARD_DEVIATION 3.3 • n=113 Participants	23.5 centimeters STANDARD_DEVIATION 5.1 • n=163 Participants	24.6 centimeters STANDARD_DEVIATION 4.2 • n=160 Participants

PRIMARY outcome

Timeframe: 1 year

Percentage of soldiers with ankle and knee injuries during the study period.

Outcome measures

Measure	Functional Training n=64 Participants 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. Exercise: neuromuscular training	Regular Army Training n=41 Participants Regular military training.
Number of Soldiers With Ankle and Knee Injuries	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 15 weeks

jump height in countermovement jump

Outcome measures

Measure	Functional Training n=64 Participants 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. Exercise: neuromuscular training	Regular Army Training n=41 Participants Regular military training.
Vertical Jump Performance	35.4 centimeters Standard Deviation 10.3	29.9 centimeters Standard Deviation 10.8

SECONDARY outcome

Timeframe: 15 weeks

number of overhand pull-ups in one minute

Outcome measures

Measure	Functional Training n=64 Participants 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. Exercise: neuromuscular training	Regular Army Training n=41 Participants Regular military training.
Pull-ups Performance	6 repetitions Standard Deviation 4	4 repetitions Standard Deviation 4

SECONDARY outcome

Timeframe: 15 weeks

Number of single leg raises on the 60 cm box

Outcome measures

Measure	Functional Training n=64 Participants 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. Exercise: neuromuscular training	Regular Army Training n=41 Participants Regular military training.
Hamstring Repetitive Strength	25 repeitions Standard Deviation 8	25 repeitions Standard Deviation 7

Adverse Events

Functional Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regular Military Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vedran Hadzic

FACULTY OF SPORT

Phone: +38615207700

Email: vedran.hadzic@fsp.uni-lj.si

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place