Muscle StrengthNCT03973060
Effectiveness of Muscular Work and Genetic Variants in Strength Gain of Ischiofemoral and Quadriceps
A study testing Concentric-eccentric muscular work and Genetic polymorphism in people with Muscle Strength and Genetics, run by Universidad Francisco de Vitoria.
Trial summary
In the field of sports training and recovery, the work of muscular strength has become the star theme in terms of its influence on the performance of athletes. In fact, in relation to the training of the inferior members, the scientific evidence indicates that, to increase the other two physical qualities conditioned… Read more about this study
- Who is it for?
- Ages 21 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Genetics
- What is being tested?
- Concentric-eccentric muscular work and Genetic polymorphism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 12 Jul 2017
- 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 21 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects that did not present musculoskeletal lesions in the lower train at the time of the study.
- Subjects that showed a serious commitment to perform the entire muscle training.
- Subjects not subject to another type of training plan that could interfere with the results obtained from the measurement of the study variables.
Who cannot join
- Subjects with high blood pressure.
About this study
Official title: Effectiveness of Muscular Work in Strength Gain of Ischiofemoral and Quadriceps: Relationshionship of Genetic Variants in Improvement of Explosive Force
In the field of sports training and recovery, the work of muscular strength has become the star theme in terms of its influence on the performance of athletes. In fact, in relation to the training of the inferior members, the scientific evidence indicates that, to increase the other two physical qualities conditioned (speed and resistance), it is necessary to work and to increase the muscular strength.
Randomized intervention trial with sample size of 80 subjects divided into 4 groups (n = 20) of muscular work: concentric, eccentric, concentric-eccentric and isometric. Ages between 21-23 years.
For all the above, the investigators will study as a main objective analyze what type of muscular work is most effective in order to improve some variables of the performance of explosive muscular strength, and to try to determine if that improvement is due, exclusively to the developed training or to the genetics of the subjects and compare the results obtained in the variables of vertical jump, power of saint, horizontal jump and speed 60 meters, before and after the execution of each one of the muscular works dynamic among themselves, and compared to the muscular work isometric.
Read the detailed description
In the field of sports training and recovery, the work of muscular strength has become the star theme in terms of its influence on the performance of athletes. In fact, in relation to the training of the inferior members, the scientific evidence indicates that, to increase the other two physical qualities conditioned (speed and resistance), it is necessary to work and to increase the muscular strength.
To this end, numerous training methods have been developed, in which research and technology provide new solutions that favor and enhance the muscular work done.
Therefore, in the performance of an athlete this work of force influences, and what this implies: type of muscular contraction, way of working that contraction, recruitment of the muscular fiber, and modality of muscular strength developed. But, this performance, it appears that it can also be influenced by environmental parameters such as diet, technological support and genetic factors. It has been discovered in the human genome 12 million of polymorphisms, but it is only recorded that some 214 may have influence on physical qualities, and all of them, the most studied in terms of their influence on sports performance are: genes Muscular, and more specifically the ACTN3, and vasomotor genes that affect the production of energy and that intervene in metabolic processes (ACE gene).
- Design: Randomized intervention clinical trial, double blinded.
- Sample: by contrast of hypothesis, a sample size of 80 subjects divided into 4 groups (n = 20) of muscular work: concentric, eccentric, concentric-eccentric and isometric. They were randomized using excel software. As criteria of inclusion, subjects that did not present musculoskeletal lesions in the lower train at the time of the study, which showed a serious commitment to perform the entire muscle training, which were not subject to another type of plan Training that could interfere with the results obtained from the measurement of the study variables, and that would not have been diagnosed with hypertension.
- Methodology:
The duration of the muscular work was 12 consecutive days, measuring before and after the same variables indicated below.
The protocol of work was as follows: 4 series of 12 repetitions of the type of muscular contraction of each group, with one minute of rest between series and series. For the muscular work isometric: 6 seconds of contraction, with 20 seconds of rest, for a total working time of 12 minutes.
As a material for muscular work, the muscle brace or Russian belt was used for the three types of dynamic muscular work and the quadriceps bench for isometric muscular work. Other variables that were taken into account were: sex, age, weight, height, body mass index, blood pressure and heart rate.
As explosive force variables were measured: The Jump Power (Sayers formula), the vertical jump (the Sargent jump test), horizontal jump and speed 60 meters.
Other variables that were taken into account were: sex, age, weight, height, body mass index, blood pressure and heart rate.
At the end of the 12 days of training was extracted 10 ml of blood to each subject of the sample, then obtain the DNA analysis of the genotypes of the two genes analyzed.
- Conditions
- Muscle Strength, Genetics
- Being tested
- Concentric-eccentric muscular work, Genetic polymorphism
- Keywords
- Jump test, Genetic polymorphism, Muscle strength, Physiotherapies techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentric-eccentric muscular workDevice
Also called Muscular work, Vertical jump, 60m sprint, Jump potence
For muscular contraction, the physiotherapist carried out 12 repetitions with one minute rest between series and series, total working time of 12 minutes.
Genetic polymorphismGenetic
Also called ACTN3 gene, ACE gene
Genetic polymorphism study by Polymerase Chain Reaction (PCR) to determine whether the genetic makeup of individuals for the improvement of muscular work in the results of the study.
| Study group | Role | What they receive |
|---|---|---|
| Concentric muscular work | Experimental | 4 series of 12 repetitions of concentric muscular work, with one minute rest between each repetitions, total working time of 24 minutes. Receives: Device: Concentric-eccentric muscular work; Genetic: Genetic polymorphism |
| Eccentric muscular work | Experimental | 4 series of 12 repetitions of eccentric muscular work, with one minute rest between each repetitions, total working time of 24 minutes. Receives: Device: Concentric-eccentric muscular work; Genetic: Genetic polymorphism |
| Concentric-eccentric muscular work | Experimental | 4 series of 12 repetitions of concentric-eccentric muscular work, with one minute rest between each repetitions, total working time of 24 minutes. Receives: Device: Concentric-eccentric muscular work; Genetic: Genetic polymorphism |
| Isometric muscular work | Experimental | 6 seconds of contraction, with 20 seconds of rest with 24 repetitions, for a total working time of 12 minutes. Receives: Device: Concentric-eccentric muscular work; Genetic: Genetic polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jump power
Mechanical power in jump tests were measured by estimated (indirect way) from a subject's jump height and body mass, by means of Sayers equation.
Measured: Changes from baseline and at the end of procedure (12 days)
Vertical jump
The protocol followed for the measurement was; First time: When the patient was barefoot, he placed himself sideways to a smooth wall and raised his right arm with his hand flat on the wall; The distance from the ground to the third finger of the hand (H1) was then measured. Second time: The subject was impregnated the third finger of the right hand in blue chalk powder, separated 10 centimeters from the wall and made a jump back movement with freedom to flex the lower limbs to the 90 º and move the arms, to consecutively and without any pause make a maximum vertical jump. Subsequently, this new distance was measured. This jump was made three times with a break between jump and jump of 45 seconds, and the average of the three (H2) was obtained. Third time: The value of the vertical jump was H = h1-h2.
Measured: Changes from baseline and at the end of procedure (12 days)
Horizontal jump
On a smooth and horizontal surface, different marks were made distanced one meter each. In the first mark the subject was placed with the feet slightly separated at the height of the hips. Then a first test jump was made; To do so, the subject was told to swing with his arms and bending his knees, he had to jump forward with the greatest possible power. Once this first Test jump was made, the second measurement was carried out, the result of which was taken into account. This result was obtained in centimeters by means of measuring tape, with a precision of one millimeter (mm), and having as points of reference the first mark and the heel of the foot more retarded. The jump was not valid if the first mark was exceeded with the feet before taking off from the ground.
Measured: Changes from baseline and at the end of procedure (12 days)
60 meters sprint
On an unobstructed sand surface, a distance of 60 meters was pointed out. The measurement in seconds of this variable was obtained by means of a stopwatch.
Measured: Changes from baseline and at the end of procedure (12 days)
Secondary outcomes (2)
ACTN3 polymorphism
Blood sample was taken from 10ml in EDTA tube to all subjects in the study and by PCR analyzed the polymorphism R577X which is defined in the bibliography as a predetermined for the type of muscle fibers.
Measured: Baseline.
ACE polymorphism
Blood sample was taken from 10ml in EDTA tube to all subjects in the study and by PCR analyzed the polymorphism I/D that is defined in the bibliography as influential in blood pressure.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Oct 2015
- Primary completion1 Feb 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- Sofía Laguarta Val, Alberto Melián Ortiz
- Responsible party
- Principal investigator, David Varillas Delgado, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973060
- Sponsor's protocol ID
- URJC
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 4 Jun 2019
- 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Muscular Work in Strength Gain of Ischiofemoral and Quadriceps: Relationshionship of Genetic Variants in Improvement of Explosive Force
- ClinicalTrials.gov ID
- NCT03973060
- Acronym / sponsor ID
- URJC
- Conditions
- Muscle Strength, Genetics
- Keywords
- Jump test, Genetic polymorphism, Muscle strength, Physiotherapies techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- Sofía Laguarta Val, Alberto Melián Ortiz
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 4 Jun 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.
In the field of sports training and recovery, the work of muscular strength has become the star theme in terms of its influence on the performance of athletes. In fact, in relation to the training of the inferior members, the scientific evidence indicates that, to increase the other two physical qualities conditioned (speed and resistance), it is necessary to work and to increase the muscular strength.
Randomized intervention trial with sample size of 80 subjects divided into 4 groups (n = 20) of muscular work: concentric, eccentric, concentric-eccentric and isometric. Ages between 21-23 years.
For all the above, the investigators will study as a main objective analyze what type of muscular work is most effective in order to improve some variables of the performance of explosive muscular strength, and to try to determine if that improvement is due, exclusively to the developed training or to the genetics of the subjects and compare the results obtained in the variables of vertical jump, power of saint, horizontal jump and speed 60 meters, before and after the execution of each one of the muscular works dynamic among themselves, and compared to the muscular work isometric.
Detailed description
In the field of sports training and recovery, the work of muscular strength has become the star theme in terms of its influence on the performance of athletes. In fact, in relation to the training of the inferior members, the scientific evidence indicates that, to increase the other two physical qualities conditioned (speed and resistance), it is necessary to work and to increase the muscular strength.
To this end, numerous training methods have been developed, in which research and technology provide new solutions that favor and enhance the muscular work done.
Therefore, in the performance of an athlete this work of force influences, and what this implies: type of muscular contraction, way of working that contraction, recruitment of the muscular fiber, and modality of muscular strength developed. But, this performance, it appears that it can also be influenced by environmental parameters such as diet, technological support and genetic factors. It has been discovered in the human genome 12 million of polymorphisms, but it is only recorded that some 214 may have influence on physical qualities, and all of them, the most studied in terms of their influence on sports performance are: genes Muscular, and more specifically the ACTN3, and vasomotor genes that affect the production of energy and that intervene in metabolic processes (ACE gene).
- Design: Randomized intervention clinical trial, double blinded.
- Sample: by contrast of hypothesis, a sample size of 80 subjects divided into 4 groups (n = 20) of muscular work: concentric, eccentric, concentric-eccentric and isometric. They were randomized using excel software. As criteria of inclusion, subjects that did not present musculoskeletal lesions in the lower train at the time of the study, which showed a serious commitment to perform the entire muscle training, which were not subject to another type of plan Training that could interfere with the results obtained from the measurement of the study variables, and that would not have been diagnosed with hypertension.
- Methodology:
The duration of the muscular work was 12 consecutive days, measuring before and after the same variables indicated below.
The protocol of work was as follows: 4 series of 12 repetitions of the type of muscular contraction of each group, with one minute of rest between series and series. For the muscular work isometric: 6 seconds of contraction, with 20 seconds of rest, for a total working time of 12 minutes.
As a material for muscular work, the muscle brace or Russian belt was used for the three types of dynamic muscular work and the quadriceps bench for isometric muscular work. Other variables that were taken into account were: sex, age, weight, height, body mass index, blood pressure and heart rate.
As explosive force variables were measured: The Jump Power (Sayers formula), the vertical jump (the Sargent jump test), horizontal jump and speed 60 meters.
Other variables that were taken into account were: sex, age, weight, height, body mass index, blood pressure and heart rate.
At the end of the 12 days of training was extracted 10 ml of blood to each subject of the sample, then obtain the DNA analysis of the genotypes of the two genes analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Concentric muscular work | Experimental | Device: Concentric-eccentric muscular work, Genetic: Genetic polymorphism4 series of 12 repetitions of concentric muscular work, with one minute rest between each repetitions, total working time of 24 minutes. |
| Eccentric muscular work | Experimental | Device: Concentric-eccentric muscular work, Genetic: Genetic polymorphism4 series of 12 repetitions of eccentric muscular work, with one minute rest between each repetitions, total working time of 24 minutes. |
| Concentric-eccentric muscular work | Experimental | Device: Concentric-eccentric muscular work, Genetic: Genetic polymorphism4 series of 12 repetitions of concentric-eccentric muscular work, with one minute rest between each repetitions, total working time of 24 minutes. |
| Isometric muscular work | Experimental | Device: Concentric-eccentric muscular work, Genetic: Genetic polymorphism6 seconds of contraction, with 20 seconds of rest with 24 repetitions, for a total working time of 12 minutes. |
Who may qualify
- Ages
- 21 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects that did not present musculoskeletal lesions in the lower train at the time of the study.
- Subjects that showed a serious commitment to perform the entire muscle training.
- Subjects not subject to another type of training plan that could interfere with the results obtained from the measurement of the study variables.
Key exclusion criteria (1 listed)
- Subjects with high blood pressure.
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 |
|---|---|---|
| Concentric-eccentric muscular workAlso: Muscular work, Vertical jump, 60m sprint, Jump potenceFor muscular contraction, the physiotherapist carried out 12 repetitions with one minute rest between series and series, total working time of 12 minutes. | Device | Concentric muscular work, Concentric-eccentric muscular work, Eccentric muscular work, Isometric muscular work |
| Genetic polymorphismAlso: ACTN3 gene, ACE geneGenetic polymorphism study by Polymerase Chain Reaction (PCR) to determine whether the genetic makeup of individuals for the improvement of muscular work in the results of the study. | Genetic | Concentric muscular work, Concentric-eccentric muscular work, Eccentric muscular work, Isometric muscular work |
Primary outcome
Jump power
Time frame: Changes from baseline and at the end of procedure (12 days)
Mechanical power in jump tests were measured by estimated (indirect way) from a subject's jump height and body mass, by means of Sayers equation.
Vertical jump
Time frame: Changes from baseline and at the end of procedure (12 days)
The protocol followed for the measurement was; First time: When the patient was barefoot, he placed himself sideways to a smooth wall and raised his right arm with his hand flat on the wall; The distance from the ground to the third finger of the hand (H1) was then measured. Second time: The subject was impregnated the third finger of the right hand in blue chalk powder, separated 10 centimeters from the wall and made a jump back movement with freedom to flex the lower limbs to the 90 º and move the arms, to consecutively and without any pause make a maximum vertical jump. Subsequently, this new distance was measured. This jump was made three times with a break between jump and jump of 45 seconds, and the average of the three (H2) was obtained. Third time: The value of the vertical jump was H = h1-h2.
Horizontal jump
Time frame: Changes from baseline and at the end of procedure (12 days)
On a smooth and horizontal surface, different marks were made distanced one meter each. In the first mark the subject was placed with the feet slightly separated at the height of the hips. Then a first test jump was made; To do so, the subject was told to swing with his arms and bending his knees, he had to jump forward with the greatest possible power. Once this first Test jump was made, the second measurement was carried out, the result of which was taken into account. This result was obtained in centimeters by means of measuring tape, with a precision of one millimeter (mm), and having as points of reference the first mark and the heel of the foot more retarded. The jump was not valid if the first mark was exceeded with the feet before taking off from the ground.
60 meters sprint
Time frame: Changes from baseline and at the end of procedure (12 days)
On an unobstructed sand surface, a distance of 60 meters was pointed out. The measurement in seconds of this variable was obtained by means of a stopwatch.
2 secondary outcomes
ACTN3 polymorphism
Time frame: Baseline.
ACE polymorphism
Time frame: Baseline.
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 4 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Concentric-eccentric muscular work and Genetic polymorphism in people with Muscle Strength and Genetics, run by Universidad Francisco de Vitoria.
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 3 inclusion and 1 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Jump power (time frame: Changes from baseline and at the end of procedure (12 days)). The study lists 4 primary outcomes in all. 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 4 Jun 2019.