Exploring Physical Exercise for the Regulation and Control of Metabolic Disorders in College Students.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversidad de Colima

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physical exercise prescription: Continuous aerobic training (jogging, swimming, static cycling)

    Behavioral

    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

  • Control group: Continuous aerobic physical exercise

    Behavioral

    Control 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

48 Participants
are divided into 2 treatment groups
Group A: Continuous aerobic physical exercise program with progressive intensity loadsExperimental treatment 1 intervention
Group B: Continuous aerobic physical exerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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.

Time frame
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.
3

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.

Time frame
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.
4

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

Time frame
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.

Secondary outcomes

1

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.

Time frame
Only at the beginning of the protocol

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Colima

Lead sponsor

Pedro Julián Flores Moreno

Collaborator

Nelson Enrique Ramos Cuevas

Collaborator

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