Military ActivityNCT03866889
Guided Training Program of Maximum Strength in Military Personnel
A study testing Strength and Normal activity in people with Military Activity, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Military Activity
- What is being tested?
- Strength and Normal activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2019to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Intervention Through a Guided Training Program of Maximum Strength, in the Improvement of the Functionality of the Lower Member in Military Personnel. A Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Military Activity
- Being tested
- Strength, Normal activity
- Keywords
- Strength, Military, Functionality, Physiotherapy, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrengthOther
Also called Maximum 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 activityOther
Also called Maximum 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Other: Normal activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start4 Mar 2019
- Primary completion10 May 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Military ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866889
- Sponsor's protocol ID
- SOLDUNI project
- Status last verified
- Jan 2020
- First submitted
- 1 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intervention Through a Guided Training Program of Maximum Strength, in the Improvement of the Functionality of the Lower Member in Military Personnel. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03866889
- Acronym / sponsor ID
- SOLDUNI project
- Conditions
- Military Activity
- Keywords
- Strength, Military, Functionality, Physiotherapy, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength | Experimental | Other: StrengthMaximum 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). |
| Normal activity | Active comparator | Other: Normal activityThe 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) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrengthAlso: Maximum strengthIn 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. | Other | Strength |
| Normal activityAlso: Maximum strengthThe 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. | Other | Normal activity |
Primary outcome
Change from baseline Maximum strength after treatment and at one month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
2 secondary outcomes
Change from baseline lower limb functionality after treatment and at one month
Time frame: 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
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and Normal activity in people with Military Activity, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Maximum strength after treatment and at one month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.