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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03866889
Other study ID # SOLDUNI project
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 4, 2019
Est. completion date June 15, 2019

Study information

Verified date January 2020
Source Investigación en Hemofilia y Fisioterapia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction. The members of the Military Emergency Unit must be physically prepared for any type of situation where required, although their strength training does not follow any concrete structure. Structured training of maximum strength aims to increase the recruitment of different types of fibers, and the increase in the size of these.

Objectives: To evaluate the effectiveness of a maximum strength training protocol in lower extremity functionality in military personnel aged 25 to 45 years.

Study design. Randomized, single-blind clinical study with follow-up period. Methodology. 65 male subjects will be recruited, who will be randomly assigned to the two study groups: experimental (structured strength training) and control (they will continue with their usual routine of free training). The intervention will last for 8 weeks, with 2 weekly sessions, lasting 20 minutes, with three evaluations (baseline, posttreatment and follow-up). The study variables will be: lower limb functionality (assessed by Standing Long Jump and Single Leg Hop tests), and quadriceps and hamstring strength (evaluated with the MRI measurement for each exercise). To perform the analysis of normality, the Kolmogorov Smirnof test will be used. In case of homogeneity, with the t-student test of repeated measures and an ANOVA of repeated means, the difference between the different evaluations and the intra and intersubject effect, respectively, will be calculated.

Expected results. Effectiveness of structured training of maximum strength in functionality of lower extremities.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date June 15, 2019
Est. primary completion date May 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

- Military personnel belonging to the Military Emergency Unit

- male

- With an age of 25 to 45 years

- No history of musculoskeletal injury in the 3 months prior to the study

Exclusion Criteria:

- Present a diagnosis of injury in the period prior to or during the study

- Who are receiving a physiotherapy intervention at the time of the study

- Not signed the informed consent document

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Strength
In the performance of the squat exercise (Back Squat), the subjects will be standing, with an Olympic bar behind their neck, supported on both trapezoids, while the hands will help to hold and stabilize the bar, taking it from below. For hamstring curl, the subject will be in the prone position, clinging to the backrest, with the legs under the arm that lifts the weight. The deadlift exercise will be performed from the standing posture, holding the bar with your arms extended and the trunk straight, while your hands will hold the bar at the height and separation of the hips. Finally, in the quadriceps chair the subject will find himself sitting with his back straight and supported on the back of the seat, while the legs will go under the arm that lifts the weight.
Normal activity
The subjects included in the control group will continue to perform the same strength training plan that they did before starting this one. The periodicity will be the same (4 days / week) and with the same intensity.

Locations

Country Name City State
Spain Universidad Europea de Madrid Madrid Comunity Of Madrid

Sponsors (1)

Lead Sponsor Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Maximum strength after treatment and at one month The RM strength assessment protocol will be used. In the squat you will be asked to bend your knees and hips over ninety degrees, then return to the starting position. In deadlift, you will be asked to take the bar from the height of the hips to just below the label, keeping the trunk upright, facing the front. Both in the quadriceps chair and in the hamstring curl, you will be asked to perform the lifting of the indicated weight, following the movement allowed by the machine to be used. The greater the weight lifted (in kg), the greater muscular strength. Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Change from baseline lower limb functionality after treatment and at one month The assessment of the lower limb functionality will be carried out by Standing Long Jump.In the use of Standing Long Jump, with the subject standing, behind a demarcated line aligns the tips of the feet, a squat will be requested by throwing the arms backwards and ordering the performance of a bipodal jump, with impulse of the extremities inferior ones, helping themselves with the balancing of the superiors. The distance traveled will be measured in centimeters and the test will only be valid when the subject lands with both limbs without losing balance. At greater distance (cm), greater functionality of lower limbs. Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Change from baseline lower limb functionality after treatment and at one month The functionality was measured with the Standing Long Jump test, with the subject standing, behind a demarcated line aligns the tips of the feet. You will be asked to squat by throwing your arms behind you and ordering a bipodal jump, with impulse of the lower limbs being helped by the swing of the upper ones. The distance traveled will be measured in centimeters and the test will only be valid when the subject lands with both limbs without losing balance. The measurement is made from the starting line to the landing point coinciding with the tip of the subject's feet. This test is done in a monopodal way. At greater distance (cm), greater functionality of lower limbs. Screening visit, within the first seven days after treatment and after one month follow-up visit
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