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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Mexico1 site
  • Universidad de Colima

    Colima, 28040

Other trials in Mexico

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 groups in NCT04059120
Study groupRoleWhat they receive
Experimental groupExperimentalThe 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 groupActive comparatorThe 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.

  1. 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)
  1. 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)

  2. 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.

  1. First posted16 Aug 2019
  2. Study start30 Mar 2018
  3. Primary completion23 Jun 2020
  4. Study completion17 Aug 2020

Resources

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)
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 11153730
  • Wilmore, 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 23247672
  • Wyatt, 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 2097018
  • Sesboue 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 16757054
  • Kreher JB, Schwartz JB. Overtraining syndrome: a practical guide. Sports Health. 2012 Mar;4(2):128-38. doi: 10.1177/1941738111434406.

    PubMed 23016079
  • Jackson 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

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.

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