ExerciseBDNF&ExeNCT04059120
Expression of BNDF Through Stretching and Recovery
A study testing Experimental group whit specific stretching in people with Exercise, run by Universidad de Colima at 1 site in Mexico.
Trial summary
The phenomena of biological adaptation and overtraining are closely related terms, that is why in sport it is possible to identify two types of overtraining. The first of these is known as short-term overtraining, which is required as a state of peripheral fatigue induced by repeated sessions of physical activity in… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Experimental group whit specific stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 30 Mar 2018to 17 Aug 2020
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a student of the degree in physical education and sports at the University of Colima.
- Men with ages from 18 to 25 years.
- Lead a moderate sedentary or active recreational lifestyle
- Sign the act of voluntary participation in the study, with the precise knowledge of the qualifications and the procedures applied.
- Having completed the Tecumseh test, passing the test and knowing the level of physical fitness
- Have been diagnosed as healthy after being submitted to the clinical assessment.
Who cannot join
- Presenting metabolic alterations such as type I or II diabetes
- Having chronic respiratory diseases such as pulmonary, chronic obstructive disease, asthma, emphysema or cancer.
- Having high blood pressure or arrhythmia.
- Be under a physical training of muscular strength or aerobic resistance with high-performance direction.
- Be under some drug treatment or drug use.
- Elimination criteria
Show all 10Show fewer
- All subjects who wish to leave the study voluntarily
- Those subjects who present ostiomyoarticular and skeletal injuries caused by the physical exercise performed. A medical specialist in sports medicine, a person at work, a medical care channel.
- Subjects who present symptoms of wear or corrosion during the training received. Same that will be directed to make a break, in addition to attended and monitored by a sports doctor. From the need for more attention, they will be channeled to the familiar doctor.
- Those who do not comply with 70% attendance to the physical training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of BNDF Through Stretching as a Recovery Mechanism in Subjects With Overtraining
The phenomena of biological adaptation and overtraining are closely related terms, that is why in sport it is possible to identify two types of overtraining. The first of these is known as short-term overtraining, which is required as a state of peripheral fatigue induced by repeated sessions of physical activity in short periods of time that are related to mechanisms of metabolic type, is considered desirable and normal, by allowing mechanisms of adaptation to be activated depending on the nature and administration of the loads, which allow reaching higher yield quotas. The second, long-term overtraining, is characterized by a series of signs and symptoms of exhaustion and persistent fatigue that take place at the level of the central nervous system and that are produced by the imbalance between demanding physical work and recovery periods.This type of condition is also known as, general syndrome of overtraining (GSO), unexplained low performance syndrome, staleness or burnout, which is propitiated by the need to achieve maximum physical performance and the performance of physical activities in a uncontrolled that cause an interruption to the processes of biological recovery that attenuate the obtaining of the physical form wished, reason why the sportsman experiences a decrease of the physical and mental performance, manifested in a clinical picture that reflects muscular inflammation, headache, elevation sudden blood pressure, loss of functional capacity, alterations of the central nervous system (CNS), metabolic, endocrine and immune systems.
The stretching is commonly used as a method of physical rehabilitation. The actual information about how the GSO can reduce or prevent in the athlete are no cleared yet, that is the way the information regarding the relationship with the GSO, the stretching, the expression of BDNF and the effects can produce in the regenerative capacity in the over-trained subjects and their compensatory mechanisms during the different cycles of physical exercise, is null, making necessary the investigation of the effects that can produce in the decrease of factors that indicate GSO.
Read the detailed description
Introduction. The phenomena of biological adaptation and overtraining are closely related terms, that is why in sport it is possible to identify two types of overtraining. The first of these is known as short-term overtraining, which is required as a state of peripheral fatigue induced by repeated sessions of physical activity in short periods of time that are related to mechanisms of metabolic type (e.g. low levels of glycogen), is considered desirable and normal, by allowing mechanisms of adaptation to be activated depending on the nature and administration of the loads, which allow reaching higher yield quotas. The second, long-term overtraining, is characterized by a series of signs and symptoms of exhaustion and persistent fatigue that take place at the level of the central nervous system and that are produced by the imbalance between demanding physical work and recovery periods.
This type of condition is also known as, general syndrome of overtraining (GSO), unexplained low performance syndrome, staleness or burnout, which is propitiated by the need to achieve maximum physical performance and the performance of physical activities in a uncontrolled that cause an interruption to the processes of biological recovery that attenuate the obtaining of the physical form wished, reason why the sportsman experiences a decrease of the physical and mental performance, manifested in a clinical picture that reflects muscular inflammation, headache, elevation sudden blood pressure, loss of functional capacity, alterations of the central nervous system (CNS), metabolic, endocrine and immune systems. The neurotrophic factor derived from the brain (BDNF) influences different types of neurons in the CNS, promoting their differentiation, growth, survival, and neuroprotection by activating the mechanisms of synaptic plasticity.
BDNF decreases when performing specific physical exercises with intensities under the interval (mixed) and high-intensity method; as those who are employed in competitive cycles. For its part, stretching is commonly used as a method of physical rehabilitation in patients with musculoskeletal injuries of various origins. Its effect reflects the restoration of motor control by interacting with the intervention and order centers that are located in different parts of the CNS that are associated with the modulation of the discharge of the motor neurons involved in the activation of the muscle spindle, which allow the reflex for the execution of the movement and the control of postures. The information regarding the relationship with the GSO, the stretching and the expression of BDNF in the regenerative capacity in those over-trained subjects and their compensatory mechanisms during the different cycles of physical exercise, is null, making necessary the investigation of the effects that can produce in the decrease of factors that indicate GSO and, consequently, build support systems for the athlete with the purpose of returning it to a level of adequate physical performance.
Problem Statement. The training cycles are configured with the purpose of achieving a greater adaptation to the physical activity that is performed. However, those closest to the competition have more intensity and physical demands. However, the achievement of maximum performance and the GSO are phenomena deeply related to the adaptability of the organism. The strategies commonly used to recover an athlete with GSO, are directed to the care of diet and rest, however, do not make clear by what methods and means it is possible to perform a restoration of regenerative processes and muscle contraction to decrease of chronic fatigue and in turn the maintenance of physical performance achieved in previous cycles.
Research question. What are the effects of a stretching training program on BDNF expression and its relationship with biochemical and physiological markers that indicate GSO?
General objective. To analyze the effects of a stretching training program on the expression of BDNF and decrease of biochemical and physiological markers that indicate GSO.
Methodology. A clinical trial, with simple blinding.
Type of sampling. Probabilistic, simple random (tombola).
Sample size. 72 subjects, 36 subjects per group, which was estimated through the equation for comparison of means.
Selection criteria. To be a university student, males from 18 to 25 years of age, to lead a moderately active or sedentary lifestyle, to sign an informed consent form, to take the physical fitness level test and to have been diagnosed as healthy in the clinical assessment.
Attention to adverse effects. These will be classified into three types, milder, will be those muscular discomforts present but tolerable, e.g. delayed muscle pain (stiffness), edema, localized fatigue, loss of mobility, loss of strength. Moderate, physical damage that interferes with physical activities, such as, first or second-degree sprain and first-degree muscle tear. Severe, those injuries and/or physical damage that incapacitates the subject to perform physical activities of any kind, such as ruptures, severe muscular, ligamentous and cartilaginous of the third degree, dislocations and fractures. If one of the two previous cases are presented, the subjects will be assisted by the sports doctor who is part of the research protocol and channeled to the corresponding family medical clinic.
Instruments. Questionnaire PAR Q \& YOU used to know the state of health and habits of physical activity. The biochemical tests will be carried out with a blood sample of 5 ml using a BD Vacutainer yellow tube model 368159 with gel separator and coagulation activator, which will estimate the concentrations of creatine phosphokinase, testosterone, cortisol, and brain-derived neurotrophic factor, which will be quantified with the ELISA method. The physiological determinants will be measured with the general stretching index test (GSI), which is calculated by the sum of the stretching in sitting, standing and lying down multiplied by the body surface. The level of physical fitness will be assessed with the Tecumseh step test and the VO2max with the Astrand-Rhyming test.
Physical training program. The study subjects will perform a physical exercise for 12 weeks divided into three blocks of 4 periods, organized in 3 weeks of training, plus 1 rest, which simulate physical loads similar to the periods of competition used in high-performance sports. The evaluations will be made prior to the training (basal measurement) and at the end of each of the blocks during the rest period. The physical load will be organized as follows: The control group (CG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM, as well as aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. Like the CG, the experimental group (EG) will perform the same physical load of muscular strength and aerobic resistance in combination with specific stretching exercises.
Statistical analysis. Kolmogorov Smirnov test to check the normality of the data, in case of presenting a normal distribution (p <0.05) the repeated measures ANOVA test will be applied, otherwise the Kruskal Wallis test will be applied. The correlation level will be established with the Pearson or RhO Spearman test. Factorial analysis of the relationship between variables and individuals will be applied through Hj-biplot. The analysis of variables will be carried out with the SPSS v 20.0 program, establishing a level of p <0.05 as the level of statistical significance.
Ethical considerations. The protocol was approved by the Research and Ethics in Research Committee of the State Institute of Cancerology, with registration number CICC-090218-BDNFMRS-05. Financing. $ 94,764.76. At the moment there are two ELISA kits for BDNF analysis and $ 44,286.76 are being managed with the Movimiento es Salud Foundation for the purchase and/or maquila of the testosterone, cortisol and CPK samples.
- Conditions
- Exercise
- Being tested
- Experimental group whit specific stretching, Control group whit out specific stretching
- Keywords
- Exercise, Overtraining, BDNF, Stretching
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group whit specific stretchingOther
The intervention involves a reality of physical, physical, different exercise, similar to the realist of high-performance athletes. However, this is the physical load, which is reduced with specific exercises of stretching and with it the factors that determine the syndrome of overtraining
Control group whit out specific stretchingOther
The intervention involves a reality of physical, physical, different exercise, similar to the realist of high-performance athletes. However, this is the physical load, which is reduced less than specific exercises of stretching and with it the factors that determine the syndrome of overtraining
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The physical load will be organized as follows: The experimental group (EG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM in combination with specific stretching exercises, and aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. Receives: Other: Experimental group whit specific stretching |
| Control group | Active comparator | The physical load will be organized as follows: The control group (CG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM in combination with single or general stretching exercises, and aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. Receives: Other: Control group whit out specific stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the BDNF from basal levels to 1 and 3 month
Measurement of serum concentration of the BDNF (pg/ml) by ELISA Method
Measured: Baseline, 1 month to 3 month (12 weeks)
Secondary outcomes (2)
Changes in the testosterone/cortisol index from basal levels to 1 and 3 month
Measurement of serum concentration of cortisol (µMol/l) and testoterone (nMol/l ) by ELISA Method
Measured: Baseline, 1 month to 3 month (12 weeks)
Changes of the creatine phosphokinase from basal level to 1 and 3 month
Measurement of serum concentration of the creatine phosphokinase (U/L) by ELISA method
Measured: Baseline, 1 month to 3 month (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start30 Mar 2018
- Primary completion23 Jun 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Model description
- The model of the physical training program to follow is. The subjects will perform a physical exercise for 12 weeks divided into three blocks of 4 periods, organized in 3 weeks of training, plus 1 rest, which simulate physical loads similar to the periods of competition used in high-performance sports. The evaluations will be made prior to the training (basal measurement) and at the end of each of the blocks during the rest period. The physical load will be organized as follows: The control group (CG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM, as well as aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. Like the CG, the experimental group (EG) will perform the same physical load of muscular strength and aerobic resistance in combination with specific stretching exercises
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Julian Flores Moreno, Universidad de Colima
- Investigators
- Del Río Va José Encarnación, PhD, Study director, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059120
- Sponsor's protocol ID
- 090128
- Acronym
- BDNF&Exe
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The volunteers data will no share whit other investigation because this project is for individual
Publications
Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.
PubMed 11153730Wilmore, JH & Costill DL Physiology of effort and sport. 2007. Paidotribo. Spain
Meeusen R, Duclos M, Foster C, Fry A, Gleeson M, Nieman D, Raglin J, Rietjens G, Steinacker J, Urhausen A; European College of Sport Science; American College of Sports Medicine. Prevention, diagnosis, and treatment of the overtraining syndrome: joint consensus statement of the European College of Sport Science and the American College of Sports Medicine. Med Sci Sports Exerc. 2013 Jan;45(1):186-205. doi: 10.1249/MSS.0b013e318279a10a.
PubMed 23247672Wyatt, FB, Donaldson, A, & Brown, E. The overtraining syndrome: A meta-analytic review. Journal of exercise physiology. 16 (2), 12-23, 2013
Bergado, J, Lorigados, L. Alberti, E. & Almaguer, W. Neurotrophic factor derived from the brain in brain tissue of healthy rats. Journal CENIC Biological Sciences, 2 (40), 135 - 139, 2009
González, R, Miller, R, Martínez, R, Andrade, A & Márquez, S. Adaptation in sport and its relation to overtraining. Notebooks of sports psychology. 6 (1), 81-98, 2006.
Huesca, JM. Analysis of the general index of flexibility. Sports medicine 71 (2): 65-69, 2004
Mackenzie, B. 101 Performance evaluation tests. Electric Word plc. 2005
Budgett R. Overtraining syndrome. Br J Sports Med. 1990 Dec;24(4):231-6. doi: 10.1136/bjsm.24.4.231.
PubMed 2097018Sesboue B, Guincestre JY. Muscular fatigue. Ann Readapt Med Phys. 2006 Jul;49(6):257-64, 348-54. doi: 10.1016/j.annrmp.2006.04.021. Epub 2006 Apr 27. English, French.
PubMed 16757054Kreher JB, Schwartz JB. Overtraining syndrome: a practical guide. Sports Health. 2012 Mar;4(2):128-38. doi: 10.1177/1941738111434406.
PubMed 23016079Jackson AS, Blair SN, Mahar MT, Wier LT, Ross RM, Stuteville JE. Prediction of functional aerobic capacity without exercise testing. Med Sci Sports Exerc. 1990 Dec;22(6):863-70. doi: 10.1249/00005768-199012000-00021.
PubMed 2287267
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of BNDF Through Stretching as a Recovery Mechanism in Subjects With Overtraining
- ClinicalTrials.gov ID
- NCT04059120
- Acronym / sponsor ID
- BDNF&Exe / 090128
- Conditions
- Exercise
- Keywords
- Exercise, Overtraining, BDNF, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 16 Aug 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.
The phenomena of biological adaptation and overtraining are closely related terms, that is why in sport it is possible to identify two types of overtraining. The first of these is known as short-term overtraining, which is required as a state of peripheral fatigue induced by repeated sessions of physical activity in short periods of time that are related to mechanisms of metabolic type, is considered desirable and normal, by allowing mechanisms of adaptation to be activated depending on the nature and administration of the loads, which allow reaching higher yield quotas. The second, long-term overtraining, is characterized by a series of signs and symptoms of exhaustion and persistent fatigue that take place at the level of the central nervous system and that are produced by the imbalance between demanding physical work and recovery periods.This type of condition is also known as, general syndrome of overtraining (GSO), unexplained low performance syndrome, staleness or burnout, which is propitiated by the need to achieve maximum physical performance and the performance of physical activities in a uncontrolled that cause an interruption to the processes of biological recovery that attenuate the obtaining of the physical form wished, reason why the sportsman experiences a decrease of the physical and mental performance, manifested in a clinical picture that reflects muscular inflammation, headache, elevation sudden blood pressure, loss of functional capacity, alterations of the central nervous system (CNS), metabolic, endocrine and immune systems.
The stretching is commonly used as a method of physical rehabilitation. The actual information about how the GSO can reduce or prevent in the athlete are no cleared yet, that is the way the information regarding the relationship with the GSO, the stretching, the expression of BDNF and the effects can produce in the regenerative capacity in the over-trained subjects and their compensatory mechanisms during the different cycles of physical exercise, is null, making necessary the investigation of the effects that can produce in the decrease of factors that indicate GSO.
Detailed description
Introduction. The phenomena of biological adaptation and overtraining are closely related terms, that is why in sport it is possible to identify two types of overtraining. The first of these is known as short-term overtraining, which is required as a state of peripheral fatigue induced by repeated sessions of physical activity in short periods of time that are related to mechanisms of metabolic type (e.g. low levels of glycogen), is considered desirable and normal, by allowing mechanisms of adaptation to be activated depending on the nature and administration of the loads, which allow reaching higher yield quotas. The second, long-term overtraining, is characterized by a series of signs and symptoms of exhaustion and persistent fatigue that take place at the level of the central nervous system and that are produced by the imbalance between demanding physical work and recovery periods.
This type of condition is also known as, general syndrome of overtraining (GSO), unexplained low performance syndrome, staleness or burnout, which is propitiated by the need to achieve maximum physical performance and the performance of physical activities in a uncontrolled that cause an interruption to the processes of biological recovery that attenuate the obtaining of the physical form wished, reason why the sportsman experiences a decrease of the physical and mental performance, manifested in a clinical picture that reflects muscular inflammation, headache, elevation sudden blood pressure, loss of functional capacity, alterations of the central nervous system (CNS), metabolic, endocrine and immune systems. The neurotrophic factor derived from the brain (BDNF) influences different types of neurons in the CNS, promoting their differentiation, growth, survival, and neuroprotection by activating the mechanisms of synaptic plasticity.
BDNF decreases when performing specific physical exercises with intensities under the interval (mixed) and high-intensity method; as those who are employed in competitive cycles. For its part, stretching is commonly used as a method of physical rehabilitation in patients with musculoskeletal injuries of various origins. Its effect reflects the restoration of motor control by interacting with the intervention and order centers that are located in different parts of the CNS that are associated with the modulation of the discharge of the motor neurons involved in the activation of the muscle spindle, which allow the reflex for the execution of the movement and the control of postures. The information regarding the relationship with the GSO, the stretching and the expression of BDNF in the regenerative capacity in those over-trained subjects and their compensatory mechanisms during the different cycles of physical exercise, is null, making necessary the investigation of the effects that can produce in the decrease of factors that indicate GSO and, consequently, build support systems for the athlete with the purpose of returning it to a level of adequate physical performance.
Problem Statement. The training cycles are configured with the purpose of achieving a greater adaptation to the physical activity that is performed. However, those closest to the competition have more intensity and physical demands. However, the achievement of maximum performance and the GSO are phenomena deeply related to the adaptability of the organism. The strategies commonly used to recover an athlete with GSO, are directed to the care of diet and rest, however, do not make clear by what methods and means it is possible to perform a restoration of regenerative processes and muscle contraction to decrease of chronic fatigue and in turn the maintenance of physical performance achieved in previous cycles.
Research question. What are the effects of a stretching training program on BDNF expression and its relationship with biochemical and physiological markers that indicate GSO?
General objective. To analyze the effects of a stretching training program on the expression of BDNF and decrease of biochemical and physiological markers that indicate GSO.
Methodology. A clinical trial, with simple blinding.
Type of sampling. Probabilistic, simple random (tombola).
Sample size. 72 subjects, 36 subjects per group, which was estimated through the equation for comparison of means.
Selection criteria. To be a university student, males from 18 to 25 years of age, to lead a moderately active or sedentary lifestyle, to sign an informed consent form, to take the physical fitness level test and to have been diagnosed as healthy in the clinical assessment.
Attention to adverse effects. These will be classified into three types, milder, will be those muscular discomforts present but tolerable, e.g. delayed muscle pain (stiffness), edema, localized fatigue, loss of mobility, loss of strength. Moderate, physical damage that interferes with physical activities, such as, first or second-degree sprain and first-degree muscle tear. Severe, those injuries and/or physical damage that incapacitates the subject to perform physical activities of any kind, such as ruptures, severe muscular, ligamentous and cartilaginous of the third degree, dislocations and fractures. If one of the two previous cases are presented, the subjects will be assisted by the sports doctor who is part of the research protocol and channeled to the corresponding family medical clinic.
Instruments. Questionnaire PAR Q \& YOU used to know the state of health and habits of physical activity. The biochemical tests will be carried out with a blood sample of 5 ml using a BD Vacutainer yellow tube model 368159 with gel separator and coagulation activator, which will estimate the concentrations of creatine phosphokinase, testosterone, cortisol, and brain-derived neurotrophic factor, which will be quantified with the ELISA method. The physiological determinants will be measured with the general stretching index test (GSI), which is calculated by the sum of the stretching in sitting, standing and lying down multiplied by the body surface. The level of physical fitness will be assessed with the Tecumseh step test and the VO2max with the Astrand-Rhyming test.
Physical training program. The study subjects will perform a physical exercise for 12 weeks divided into three blocks of 4 periods, organized in 3 weeks of training, plus 1 rest, which simulate physical loads similar to the periods of competition used in high-performance sports. The evaluations will be made prior to the training (basal measurement) and at the end of each of the blocks during the rest period. The physical load will be organized as follows: The control group (CG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM, as well as aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. Like the CG, the experimental group (EG) will perform the same physical load of muscular strength and aerobic resistance in combination with specific stretching exercises.
Statistical analysis. Kolmogorov Smirnov test to check the normality of the data, in case of presenting a normal distribution (p <0.05) the repeated measures ANOVA test will be applied, otherwise the Kruskal Wallis test will be applied. The correlation level will be established with the Pearson or RhO Spearman test. Factorial analysis of the relationship between variables and individuals will be applied through Hj-biplot. The analysis of variables will be carried out with the SPSS v 20.0 program, establishing a level of p <0.05 as the level of statistical significance.
Ethical considerations. The protocol was approved by the Research and Ethics in Research Committee of the State Institute of Cancerology, with registration number CICC-090218-BDNFMRS-05. Financing. $ 94,764.76. At the moment there are two ELISA kits for BDNF analysis and $ 44,286.76 are being managed with the Movimiento es Salud Foundation for the purchase and/or maquila of the testosterone, cortisol and CPK samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The model of the physical training program to follow is. The subjects will perform a physical exercise for 12 weeks divided into three blocks of 4 periods, organized in 3 weeks of training, plus 1 rest, which simulate physical loads similar to the periods of competition used in high-performance sports. The evaluations will be made prior to the training (basal measurement) and at the end of each of the blocks during the rest period. The physical load will be organized as follows: The control group (CG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM, as well as aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. Like the CG, the experimental group (EG) will perform the same physical load of muscular strength and aerobic resistance in combination with specific stretching exercises
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental group whit specific stretchingThe physical load will be organized as follows: The experimental group (EG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM in combination with specific stretching exercises, and aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. |
| Control group | Active comparator | Other: Control group whit out specific stretchingThe physical load will be organized as follows: The control group (CG) will perform muscle strength exercises with intensities of 45 to 90% of 1RM in combination with single or general stretching exercises, and aerobic resistance with efforts of 60 to 90% of the theoretical maximum heart rate, which will be controlled with a Polar brand heart rate monitor model FT7. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be a student of the degree in physical education and sports at the University of Colima.
- Men with ages from 18 to 25 years.
- Lead a moderate sedentary or active recreational lifestyle
- Sign the act of voluntary participation in the study, with the precise knowledge of the qualifications and the procedures applied.
- Having completed the Tecumseh test, passing the test and knowing the level of physical fitness
Key exclusion criteria (10 listed)
- Presenting metabolic alterations such as type I or II diabetes
- Having chronic respiratory diseases such as pulmonary, chronic obstructive disease, asthma, emphysema or cancer.
- Having high blood pressure or arrhythmia.
- Be under a physical training of muscular strength or aerobic resistance with high-performance direction.
- Be under some drug treatment or drug use.
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 |
|---|---|---|
| Experimental group whit specific stretchingThe intervention involves a reality of physical, physical, different exercise, similar to the realist of high-performance athletes. However, this is the physical load, which is reduced with specific exercises of stretching and with it the factors that determine the syndrome of overtraining | Other | Experimental group |
| Control group whit out specific stretchingThe intervention involves a reality of physical, physical, different exercise, similar to the realist of high-performance athletes. However, this is the physical load, which is reduced less than specific exercises of stretching and with it the factors that determine the syndrome of overtraining | Other | Control group |
Primary outcome
Changes of the BDNF from basal levels to 1 and 3 month
Time frame: Baseline, 1 month to 3 month (12 weeks)
Measurement of serum concentration of the BDNF (pg/ml) by ELISA Method
2 secondary outcomes
Changes in the testosterone/cortisol index from basal levels to 1 and 3 month
Time frame: Baseline, 1 month to 3 month (12 weeks)
Changes of the creatine phosphokinase from basal level to 1 and 3 month
Time frame: Baseline, 1 month to 3 month (12 weeks)
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 Mar 2021.
- Background: PubMed 11153730Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.
- BackgroundWilmore, JH & Costill DL Physiology of effort and sport. 2007. Paidotribo. Spain
- Background: PubMed 23247672Meeusen R, Duclos M, Foster C, Fry A, Gleeson M, Nieman D, Raglin J, Rietjens G, Steinacker J, Urhausen A; European College of Sport Science; American College of Sports Medicine. Prevention, diagnosis, and treatment of the overtraining syndrome: joint consensus statement of the European College of Sport Science and the American College of Sports Medicine. Med Sci Sports Exerc. 2013 Jan;45(1):186-205. doi: 10.1249/MSS.0b013e318279a10a.
- BackgroundWyatt, FB, Donaldson, A, & Brown, E. The overtraining syndrome: A meta-analytic review. Journal of exercise physiology. 16 (2), 12-23, 2013
- BackgroundBergado, J, Lorigados, L. Alberti, E. & Almaguer, W. Neurotrophic factor derived from the brain in brain tissue of healthy rats. Journal CENIC Biological Sciences, 2 (40), 135 - 139, 2009
- BackgroundGonzález, R, Miller, R, Martínez, R, Andrade, A & Márquez, S. Adaptation in sport and its relation to overtraining. Notebooks of sports psychology. 6 (1), 81-98, 2006.
- BackgroundHuesca, JM. Analysis of the general index of flexibility. Sports medicine 71 (2): 65-69, 2004
- BackgroundMackenzie, B. 101 Performance evaluation tests. Electric Word plc. 2005
- Results publication: PubMed 2097018Budgett R. Overtraining syndrome. Br J Sports Med. 1990 Dec;24(4):231-6. doi: 10.1136/bjsm.24.4.231.
- Results publication: PubMed 16757054Sesboue B, Guincestre JY. Muscular fatigue. Ann Readapt Med Phys. 2006 Jul;49(6):257-64, 348-54. doi: 10.1016/j.annrmp.2006.04.021. Epub 2006 Apr 27. English, French.
- Results publication: PubMed 23016079Kreher JB, Schwartz JB. Overtraining syndrome: a practical guide. Sports Health. 2012 Mar;4(2):128-38. doi: 10.1177/1941738111434406.
- Results publication: PubMed 2287267Jackson AS, Blair SN, Mahar MT, Wier LT, Ross RM, Stuteville JE. Prediction of functional aerobic capacity without exercise testing. Med Sci Sports Exerc. 1990 Dec;22(6):863-70. doi: 10.1249/00005768-199012000-00021.
- Individual participant dataSharing planned: No. The volunteers data will no share whit other investigation because this project is for individual
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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.
Del Río Va José Encarnación, PhD study director
Universidad de Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group whit specific stretching in people with Exercise, run by Universidad de Colima at 1 site in Mexico.
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 6 inclusion and 10 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 Mar 2021. 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 Mexico. 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?
Changes of the BDNF from basal levels to 1 and 3 month (time frame: Baseline, 1 month to 3 month (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04059120, which also lists 12 linked publications.
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 Mar 2021.