NCT03866889

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

March 1, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

StrengthMilitaryFunctionalityPhysiotherapyRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline lower limb functionality after treatment and at one month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline lower limb functionality after treatment and at one month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Strength

EXPERIMENTAL

Maximum strength protocol based on a Maximum Repetition (1RM). The aim of the application of the training is to produce an increase in strength based on training with high loads (80% 1RM), individually and covering the muscles of the lower extremity (quadriceps, hamstrings, gluteus maximus).

Other: Strength

Normal activity

ACTIVE COMPARATOR

The subjects included in the control group will perform the same physical activity to improve the strenght until the beginning of the study. The exercises will be done in the same conditions and with the same period (4 days / week)

Other: Normal activity

Interventions

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.

Also known as: Maximum strength
Strength

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.

Also known as: Maximum strength
Normal activity

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Interventions

pamabrom

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 7, 2019

Study Start

March 4, 2019

Primary Completion

May 10, 2019

Study Completion

June 15, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations