Clinical trial NCT06555159: Exploring Physical Exercise for the Regulation and Control of Metabolic Disorders in College Students.
Official title: EFFECT OF AN AEROBIC EXERCISE PROGRAM ON METABOLIC DISORDERS LEVELS IN HIGHER EDUCATION STUDENTS AT THE UNIVERSITY OF COLIMA, RANDOMIZED CLINICAL TRIAL.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Disorders
Abdominal Obesity
Blood Pressure Disorders
Hypertriglyceridemia
Hyperglycemia
HDL-Deficiency
Keywords: Exercise
Obesity
HDL
Triglycerides
Hypertension
Lead sponsor: Universidad de Colima
Sponsor class: OTHER
Collaborators: name: Pedro Julián Flores Moreno
name: Nelson Enrique Ramos Cuevas
First posted: 2024-08-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 Colima's 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 project's 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 (8:00 am to 12:00 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 Queen's 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 Queen's 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 Queen's 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 ≤ 0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* University of Colima students linked to the central campus.
* Students aged between 18 and 25 years old.
* Authorization to participate in the project with a signed informed consent.
* Suffer from at least one of the parameters of metabolic disorders or cardiovascular risk (Hyperglycemia, decreased DHL, elevated triglycerides, abdominal obesity or hypertension) following the clinical assessment (Considering the criteria established by the ADA and ATPIII).

Exclusion Criteria:

* Motor limitations that may hinder the performance of physical exercise.
* Pregnancy or lactation.
* High Vigorous Physical Activity Level according to the IPA-Q.
* To be currently under pharmacological treatment to manage altered metabolic levels.

ELIMINATION CRITERIA

* Musculoskeletal injuries during the study period.
* Unforeseen Medical Events: Unexpected medical situations that could influence study results, such as hospitalizations, serious illnesses, or surgeries.
* Non-Compliance with Follow-Up: Subjects failing to meet a minimum of 80% (19 out of 24 sessions) of the stipulated physical conditioning program time.
* Initiation of clinical treatment that may affect protocol results, such as medications that reduce alterations.
* Participants who voluntarily withdraw from the study.

Primary outcomes:
measure: HDL (Lipidic profile)
timeFrame: For the selected participants, this measurement will be taken a second time, after 4 weeks of exercise prescription, and a third time at the end of the protocol, after 8 weeks.
measure: hypertriglyceridemia
timeFrame: For the selected participants, this measurement will be taken a second time, after 4 weeks of exercise prescription, and a third time at the end of the protocol, after 8 weeks.
measure: Glucose alterations
timeFrame: For the selected participants, this measurement will be taken a second time, after 4 weeks of exercise prescription, and a third time at the end of the protocol, after 8 weeks.
measure: Arterial Hypertension
timeFrame: For the selected participants, this measurement will be taken a second time, after 4 weeks of exercise prescription, and a third time at the end of the protocol, after 8 weeks.
measure: Abdominal circunference
timeFrame: At the beginning of the protocol, then 4 weeks later, and then 8 weeks later, when the intervention ends.
measure: Queen College Step Test
timeFrame: At the beginning of the protocol, then 4 weeks later, and then 8 weeks later, when the intervention ends.
Secondary outcomes:
measure: IPA Q questionnaire
timeFrame: Only at the beginning of the protocol
Other outcomes:
Locations:
city: Colima
country: Mexico
facility: University of Colima
Study officials:
affiliation: Universidad de Colima
name: Nelson Enrique Ramos Cuevas, BC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Colima
name: Fabián Rojas Larios, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Colima
name: Pedro Julián Flores, PhD
role: STUDY_DIRECTOR
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