Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555159
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Exploring Physical Exercise for the Regulation and Control of Metabolic Disorders in College Students
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EFFECT OF AN AEROBIC EXERCISE PROGRAM ON METABOLIC DISORDERS LEVELS IN HIGHER EDUCATION STUDENTS AT THE UNIVERSITY OF COLIMA RANDOMIZED CLINICAL TRIAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPE_RCTMCS
Brief Summary:
This clinical trial objective is to evaluate the effect of an aerobic physical exercise program on reducing triglycerides blood pressure abdominal obesity altered glucose levels and the increase in HDL in college-level students at the University of Colima It will try to answer whether aerobic physical exercise reduces metabolic disorders altered blood pressure and glucose levels abdominal obesity and increased HDL A simple randomized clinical trial will be conducted with a sample of 48 voluntary students from the University of Colima divided into two groups of 24 people Control group -A- will perform aerobic physical exercise which will be walking at 57 to 76 of HRmax and Experimental Group -B- will undergo an aerobic physical exercise APE program involving jogging swimming and static cycling with a progressive intensity which will start at 57-63 of the maximum heart rate HRmax in the first 4 weeks of the study and will increase to 64 -76 in the final four weeks fulfilling the principle of progressive overload
Researchers will compare the results of both groups to confirm the effectiveness of the planned aerobic physical exercise in reducing these risks
Researchers will compare the results of both groups to confirm the effectiveness of the planned aerobic physical exercise in reducing these risks
Detailed Description:
Once the project is approved by the Bioethics Committee from the Faculty of Medicine at the University of Colima and the Ethics Committee from Colimas Regional Hospital annexing a no-conflict of interest letter letters of intent will be prepared and sent to the directors of the faculties within the central campus of the University of Colima Their purpose is to inform them about the projects generalities obtain permission to share it with the students and address any questions they may have Those who agree will receive an informed consent form for their respective signatures They will be informed about the appropriate attire for the study for women this includes sports shoes leggings and a top or T-shirt and for men shorts and a T-shirt the requirement to fast for a minimum of 8 hours on the data collection day and the date Saturdays time 800 am to 1200 pm and place Faculty of Medicine University of Colima of the initial tests these tests will also be considered the baseline for people who are found to have a metabolic alteration
On assessment day the project team will execute the following tests application of the IPA-Q questionnaire abdominal circumference blood pressure blood collection by venipuncture for HDL triglycerides and glycemia and the Queens College step test to determine their cardiorespiratory capacity after completing all the tests every participant will receive refreshments and will be asked if they are in good condition to conclude their assessments if not they will be monitored until their answer is affirmative
Once all blood samples are collected they will be taken to the laboratory at the Faculty of Chemical Sciences University of Colima for processing Simultaneously data from the other assessments will be synthesized When the final results from all 5 tests are collected a sample of 48 subjects will be selected for the protocol considering the established inclusion criteria With this sample simple randomization will be performed in a new meeting using sealed envelopes each containing a letter indicating group assignment that will not be seen by participants Participants will draw an envelope and mark it with their names and they will hand the envelope to the designated person principal investigator
At the end of the meeting the envelopes will be opened by the organizers in the absence of the participants to reveal whether they belong to the A control or B experimental group This process ensures single-blind criteria where participants do not know their group assignment
After forming the A control and B experimental groups they will be divided to provide them instructions for compliance with the exercise program while maintaining single-blind conditions In the control group A the exercise prescription used by Habibzadeh in 2010 will be implemented which involves walking for 30 minutes at an intensity of 57 to 76 of the maximum heart rate three times per week Monday Wednesday and Friday for eight weeks They will always be accompanied by a previously trained physical education student Monitoring the intensity range in which the subjects must be during the session will be done through the effort perception scale heart rate at 15 seconds multiplied by 4 or the H10 polar monitor 83 On the other hand the experimental group B will engage in an aerobic exercise program jogging aquatic activities and stationary cycling lasting 40 to 60 minutes three times per week Monday Wednesday and Friday for eight weeks always under the supervision of the principal investigator Each participant in the experimental group will receive a structured exercise prescription tailored to their specific condition considering the established aerobic training ranges 57 to 63 of maximum heart rate Monitoring the intensity range in which the subjects must be during the session will be done through the effort perception scale heart rate at 15 seconds multiplied by 4 or the H10 polar monitor
By the end of the first four weeks the second round of assessments and samples will be done taking into consideration Abdominal circumference blood pressure blood collection by venipuncture for HDL triglycerides and glycemia and the Queens College step test will be performed 3 minutes after completing all the tests every participant will receive refreshments and will be asked if they are in good condition to conclude their assessments if not they will be monitored until their answer is affirmative Subsequently after completing sample collection and assessments the control group A will continue with the same dynamics as in the initial weeks The experimental group B will maintain the same exercises jogging aquatic activities and stationary cycling but their intensity may be adjusted from 64 to 76 of the maximum heart rate if favourable results are obtained from the cardiorespiratory fitness test since this shows the level of evolution of the subject after the initial intervention and thus the FITT-VP principle in exercise prescription would be fulfilled
At the end of the last 4 weeks of the aerobic physical exercise program the same sampling will be concluded Abdominal circumference arterial pressure blood collection by venipuncture for HDL triglycerides and glycemia and the Queens College step test will be performed 3 minutes after completing all the tests every participant will receive refreshments and will be asked if they are in good condition to conclude their assessments if not they will be monitored until their answer is affirmative finishing the proposed intervention protocol
The statistical analysis will be conducted using the Statistical Package for the Social Sciences SPSS Statistics 26 from Business Machine IBM Descriptive statistics will be carried out including measures of central tendency for the variables of age sex and IPA-Q Normality tests will be applied such as Kolmogorov-Smirnov for samples 50 and Shapiro-Wilk for samples 50 For the levels of triglycerides glucose HDL High-Density Lipoprotein abdominal circumference and cardiorespiratory fitness paired-sample T-tests will be used if the data follow a normal distribution but if they do not the Wilcoxon signed-rank test will be employed To compare the control and experimental groups independent-sample t-tests will be used if the data is normally distributed otherwise the Mann-Whitney U test will be used Likewise a multivariate analysis will be carried out to relate the influence of physical exercise on metabolic alterations A significance level of p 005 will be considered statistically significant
On assessment day the project team will execute the following tests application of the IPA-Q questionnaire abdominal circumference blood pressure blood collection by venipuncture for HDL triglycerides and glycemia and the Queens College step test to determine their cardiorespiratory capacity after completing all the tests every participant will receive refreshments and will be asked if they are in good condition to conclude their assessments if not they will be monitored until their answer is affirmative
Once all blood samples are collected they will be taken to the laboratory at the Faculty of Chemical Sciences University of Colima for processing Simultaneously data from the other assessments will be synthesized When the final results from all 5 tests are collected a sample of 48 subjects will be selected for the protocol considering the established inclusion criteria With this sample simple randomization will be performed in a new meeting using sealed envelopes each containing a letter indicating group assignment that will not be seen by participants Participants will draw an envelope and mark it with their names and they will hand the envelope to the designated person principal investigator
At the end of the meeting the envelopes will be opened by the organizers in the absence of the participants to reveal whether they belong to the A control or B experimental group This process ensures single-blind criteria where participants do not know their group assignment
After forming the A control and B experimental groups they will be divided to provide them instructions for compliance with the exercise program while maintaining single-blind conditions In the control group A the exercise prescription used by Habibzadeh in 2010 will be implemented which involves walking for 30 minutes at an intensity of 57 to 76 of the maximum heart rate three times per week Monday Wednesday and Friday for eight weeks They will always be accompanied by a previously trained physical education student Monitoring the intensity range in which the subjects must be during the session will be done through the effort perception scale heart rate at 15 seconds multiplied by 4 or the H10 polar monitor 83 On the other hand the experimental group B will engage in an aerobic exercise program jogging aquatic activities and stationary cycling lasting 40 to 60 minutes three times per week Monday Wednesday and Friday for eight weeks always under the supervision of the principal investigator Each participant in the experimental group will receive a structured exercise prescription tailored to their specific condition considering the established aerobic training ranges 57 to 63 of maximum heart rate Monitoring the intensity range in which the subjects must be during the session will be done through the effort perception scale heart rate at 15 seconds multiplied by 4 or the H10 polar monitor
By the end of the first four weeks the second round of assessments and samples will be done taking into consideration Abdominal circumference blood pressure blood collection by venipuncture for HDL triglycerides and glycemia and the Queens College step test will be performed 3 minutes after completing all the tests every participant will receive refreshments and will be asked if they are in good condition to conclude their assessments if not they will be monitored until their answer is affirmative Subsequently after completing sample collection and assessments the control group A will continue with the same dynamics as in the initial weeks The experimental group B will maintain the same exercises jogging aquatic activities and stationary cycling but their intensity may be adjusted from 64 to 76 of the maximum heart rate if favourable results are obtained from the cardiorespiratory fitness test since this shows the level of evolution of the subject after the initial intervention and thus the FITT-VP principle in exercise prescription would be fulfilled
At the end of the last 4 weeks of the aerobic physical exercise program the same sampling will be concluded Abdominal circumference arterial pressure blood collection by venipuncture for HDL triglycerides and glycemia and the Queens College step test will be performed 3 minutes after completing all the tests every participant will receive refreshments and will be asked if they are in good condition to conclude their assessments if not they will be monitored until their answer is affirmative finishing the proposed intervention protocol
The statistical analysis will be conducted using the Statistical Package for the Social Sciences SPSS Statistics 26 from Business Machine IBM Descriptive statistics will be carried out including measures of central tendency for the variables of age sex and IPA-Q Normality tests will be applied such as Kolmogorov-Smirnov for samples 50 and Shapiro-Wilk for samples 50 For the levels of triglycerides glucose HDL High-Density Lipoprotein abdominal circumference and cardiorespiratory fitness paired-sample T-tests will be used if the data follow a normal distribution but if they do not the Wilcoxon signed-rank test will be employed To compare the control and experimental groups independent-sample t-tests will be used if the data is normally distributed otherwise the Mann-Whitney U test will be used Likewise a multivariate analysis will be carried out to relate the influence of physical exercise on metabolic alterations A significance level of p 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None