About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Physical exercise prescription: Continuous aerobic training (jogging, swimming, static cycling)
BehavioralAerobic 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
Control group: Continuous aerobic physical exercise
BehavioralControl group -A-, will perform aerobic physical exercise, which will be walking at 57% to 76% of HRmax, keeping this intensity for the 8 week intervention period.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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
Secondary outcomes
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.
Sponsors and contacts
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Universidad de Colima
Lead sponsor
Pedro Julián Flores Moreno
Collaborator
Nelson Enrique Ramos Cuevas
Collaborator
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