Exploring Physical Exercise for the Regulation and Control of Metabolic Disorders in College Students.
NCT Number: NCT06555159
Acronym: (EPE_RCTMCS)
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Disorders|Abdominal Obesity|Blood Pressure Disorders|Hypertriglyceridemia|Hyperglycemia|HDL-Deficiency
Interventions: BEHAVIORAL: Physical exercise prescription: Continuous aerobic training (jogging, swimming, static cycling)|BEHAVIORAL: Control group: Continuous aerobic physical exercise
Sponsor: Universidad de Colima
Collaborators: Pedro Julián Flores Moreno|Nelson Enrique Ramos Cuevas
Sex: ALL
Age: ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-06
Locations: University of Colima, Colima, 28040, Mexico

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.

Primary Outcome Measures: HDL (Lipidic profile), Participants will undergo a blood extraction procedure during the test session, which will be in the care of a nurse to maximize the effectiveness of the procedure and reduce risks. Once all blood samples are collected, they will be taken to the laboratory at the Faculty of Chemical Sciences, University of Colima, for processing.

If participants have any metabolic alterations (Males \< 40 mg/dl, Females \< 50 mg/dl), they will be considered candidates for this protocol., 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.|hypertriglyceridemia, Participants will undergo a blood extraction procedure during the test session, which will be in the care of a nurse to maximize the effectiveness of the procedure and reduce risks. Once all blood samples are collected, they will be taken to the laboratory at the Faculty of Chemical Sciences, University of Colima, for processing If participants have any metabolic alterations (Males \>150 mg/dl; Females \>150 mg/dl), they will be considered candidates for this protocol.

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., 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.|Glucose alterations, Participants will undergo a blood extraction procedure during the test session, which will be in the care of a nurse to maximize the effectiveness of the procedure and reduce risks. Once all blood samples are collected, they will be taken to the laboratory at the Faculty of Chemical Sciences, University of Colima, for processing If participants have any metabolic alterations (\>110 mg/dl), they will be considered candidates for this protocol., 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.|Arterial Hypertension, Individuals have to remain seated for 5 to 10 minutes regulating their cardiorespiratory frequency. Afterwards, the clinician will start the measurement of blood pressure using a baumanometer. When the result is obtained, it will be corroborated using the cut-off points (Males \> 130/85 mmHg Females \> 130/85 mmHg), to determine the subject's participation, 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.|Abdominal circunference, For this test, a certified measuring tape will be used and it will also have the objective of determining the abdominal circumference taking into account the morphophysiological parameters established by the International Society for the Advancement of Kinanthropometry (ISAK) and a marker. The subject must be placed in an anatomical position and then will be told to raise his arms crossed at chest height. The upper edge of the iliac crest will be identified by marking it with the marker, and after that, the lower edge of the last rib will be identified, so a marking will be made, then the two established references will be taken to identify the middle area of the markings. The abdomen will be surrounded with the tape and the subject will be told to breathe normally, at the end of this, the circumference will be taken. If the subject has these measurements: Males \>90cm and Females\>85 cm, will be considered a study participant., At the beginning of the protocol, then 4 weeks later, and then 8 weeks later, when the intervention ends.|Queen College Step Test, This test aims to monitor the maximum oxygen consumption of the study subjects in 3 continuous minutes.

At the end of the test, you will remain standing for 5 seconds, followed by taking the heart rate for 15 seconds, after which the partial result will be multiplied by 4 and the total result will be given.

This result will be aligned with the percentiles of cardiorespiratory fitness, which range from 29.6 Vo2max to 42.4Vo2max in women and ranges from 34.1 Vo2max to 61 Vo2max in men, the lower the percentile, the lower the subject's cardiorespiratory capacity, which was aligned to determine your prescription for the exercise of the protocol., At the beginning of the protocol, then 4 weeks later, and then 8 weeks later, when the intervention ends.
Secondary Outcome Measures: IPA Q questionnaire, The purpose of this questionnaire in its extended version, is to evaluate the level of physical activity of study participants during the last 7 days by minutes before completion.

The total number of minutes will be added and the physical activity performed will be ranked either low, moderate or vigorous according to the guidelines determined by the WHO., Only at the beginning of the protocol