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

NCT06555159 | Not Yet Recruiting

• 1 other identifier: 2024-6
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disorders; Abdominal Obesity; Blood Pressure Disorders; Hypertriglyceridemia; Hyperglycemia; HDL-Deficiency

Keywords

Exercise; Obesity; HDL; Triglycerides; Hypertension

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• IPA Q questionnaire

  Only at the beginning of the protocol

Study Arms (2)

Continuous aerobic physical exercise program with progressive intensity loads

EXPERIMENTAL

Exercise prescription: jogging, swimming, and static cycling, three times a week with a duration of 60 minutes per exercise session 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.

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

Continuous aerobic physical exercise

ACTIVE COMPARATOR

Intervention: Performing aerobic physical exercise: walking at 57% to 76% of HRmax.

Behavioral: Control group: Continuous aerobic physical exercise

Interventions

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

Continuous aerobic physical exercise program with progressive intensity loads

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.

Continuous aerobic physical exercise

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Colima: lead
• Pedro Julián Flores Moreno: collaborator
• Nelson Enrique Ramos Cuevas: collaborator

Study Sites (1)

University of Colima

Colima, 28040, Mexico

Location

Related Publications (7)

• Kelley GA, Kelley KS, Tran ZV. Aerobic exercise and lipids and lipoproteins in women: a meta-analysis of randomized controlled trials. J Womens Health (Larchmt). 2004 Dec;13(10):1148-64. doi: 10.1089/jwh.2004.13.1148.

  PMID: 15650348 BACKGROUND

• Silveira EA, Mendonca CR, Delpino FM, Elias Souza GV, Pereira de Souza Rosa L, de Oliveira C, Noll M. Sedentary behavior, physical inactivity, abdominal obesity and obesity in adults and older adults: A systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Aug;50:63-73. doi: 10.1016/j.clnesp.2022.06.001. Epub 2022 Jun 14.

  PMID: 35871953 RESULT

• Sequi-Dominguez I, Alvarez-Bueno C, Martinez-Vizcaino V, Fernandez-Rodriguez R, Del Saz Lara A, Cavero-Redondo I. Effectiveness of Mobile Health Interventions Promoting Physical Activity and Lifestyle Interventions to Reduce Cardiovascular Risk Among Individuals With Metabolic Syndrome: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Aug 31;22(8):e17790. doi: 10.2196/17790.

  PMID: 32865503 RESULT

• Primo D, Garcia Rioja J, Izaola O, Del Rio San Cristobal C, Pinero Teno R, De Luis Roman D. [Real-world study of an online platform for the prescription of physical exercise to obese patients - Effect on anthropometric, biochemical parameters and quality of life]. Nutr Hosp. 2022 Mar 29;39(2):337-347. doi: 10.20960/nh.03842. Spanish.

  PMID: 35068165 RESULT

• Aristizabal JC, Montoya E, Sanchez YL, Yepes-Calderon M, Narvaez-Sanchez R, Gallo-Villegas JA, Calderon JC. Effects of Low-Volume, High-Intensity Interval Training Compared with Continuous Training on Regional and Global Body Composition in Adults with Metabolic Syndrome: A post hoc Analysis of a Randomized Clinical Trial. Ann Nutr Metab. 2021;77(5):279-288. doi: 10.1159/000518909. Epub 2021 Oct 6.

  PMID: 34763335 RESULT

• Alarcon-Gomez J, Chulvi-Medrano I, Martin-Rivera F, Calatayud J. Effect of High-Intensity Interval Training on Quality of Life, Sleep Quality, Exercise Motivation and Enjoyment in Sedentary People with Type 1 Diabetes Mellitus. Int J Environ Res Public Health. 2021 Nov 30;18(23):12612. doi: 10.3390/ijerph182312612.

  PMID: 34886337 RESULT

• Gallegos-Gonzalez G, Pineda-Garcia G, Serrano-Medina A, Martinez AL, Ochoa-Ruiz E. Association between Stress and Metabolic Syndrome and its Mediating Factors in University Students. Am J Health Behav. 2021 Nov 15;45(6):1091-1102. doi: 10.5993/AJHB.45.6.12.

  PMID: 34969419 RESULT

MeSH Terms

Conditions

Metabolic Diseases; Obesity, Abdominal; Hypertriglyceridemia; Hyperglycemia; Hypoalphalipoproteinemias; Motor Activity; Obesity; Hypertension

Interventions

Jogging; Swimming

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Glucose Metabolism Disorders; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Running; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Nelson Enrique Ramos Cuevas, BC

  Universidad de Colima

  PRINCIPAL INVESTIGATOR

• Fabián Rojas Larios, PhD

  Universidad de Colima

  STUDY DIRECTOR

• Pedro Julián Flores, PhD

  Universidad de Colima

  STUDY DIRECTOR

Central Study Contacts

Nelson Enrique Ramos Cuevas, BC

CONTACT

+523334702893; nramos6@ucol.mx

Fabián Rojas Larios, PhD

CONTACT

+523121206804; frojas@ucol.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants do not know if they belong to the control group or the experimental group Simple randomization will be performed using sealed envelopes, each containing a letter indicating group assignment that will not be seen by participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor en ciencias médicas

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)