High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction

Metabolic Syndrome Clinical Trial

Official title:

High Intensity Training Based on Small-sided Soccer Games for Health: Effects on Cardiometabolic Health, Motor Performance and Adherence to 24-hour Movement Guidelines in Adolescents With Overweight and Metabolic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06377137
• Other study ID #: University of the Porto
• Status: Completed
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2024
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.

The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.

The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.

A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.

Those eligible to participate in the study will be randomly assigned to one of three groups:

i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.

The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 1, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Age between 11-15 years at the time of intervention start

• Overweight or obesity (BMI> 85th percentile)

• Abdominal obesity =90th percentile as assessed by waist circumference or a waist-to- height ratio = 0.5

• Willing to participate in the study regardless of possible group allocation

• Informed consent given by participant and legal representatives

Exclusion Criteria:

• Health condition not compatible with participation in physical exercise

• History of recent musculoskeletal injury hindering exercise participation

• Concurrent participation in a structured weight loss or exercise program

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity, Adolescent
• Pediatric Obesity

Intervention

Behavioral:
• Small-sided soccer games groups (SSSG)
Physical exercise intervention
• Traditional soccer training groups (TSG)
Physical exercise intervention

Locations

Country	Name	City	State
Portugal	Faculty of Sport of the University of Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist circumference	Anthropometric measurement of abdominal obesity; cm	16 weeks
Primary	Cardiorespiratory fitness	1-mile walk/run test; minutes to run 1 mile	16 weeks
Secondary	Variation in fasting blood glucose concentration (mg/dL)	Variation in fasting blood glucose concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in serum insulin concentration (mU/L)	Variation in serum insulin concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in HOMA-IR	Variation in HOMA-IR after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in glycosylated hemoglobin concentration (mg/dL)	Variation in Glycosylated hemoglobin concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in high-density lipoprotein cholesterol concentration (mg/dL)	Variation in High-density lipoprotein cholesterol concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in low-density lipoprotein cholesterol concentration (mg/dL)	Variation in low-density lipoprotein cholesterol concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in total cholesterol concentration (mg/dL)	Variation in total cholesterol concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in blood triglycerides concentration (mg/dL)	Variation in blood triglycerides concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in blood Alanine aminotransferase concentration (U/L)	Variation in blood Alanine aminotransferase concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in blood Aspartate aminotransferase concentration (U/L)	Variation in blood Aspartate aminotransferase concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	Variation in blood Gamma glutamyl transferase concentration (U/L)	Variation in blood Gamma glutamyl transferase concentration after 16 weeks of intervention.; Blood samples will be obtained from each subject early in the morning by venipuncture from the antecubital vein, following a 10-h overnight fast.	16 weeks
Secondary	6-minute walk test	Distance covered walking in 6 minutes.	16 weeks
Secondary	Hand grip strength	Hand grip strength test measured with a digital hand dynamometer	16 weeks
Secondary	Lower limb strength	Assessed by Horizontal jump test.	16 weeks
Secondary	Body composition	Assessed by the electrical bioimpedance method	16 weeks
Secondary	Body mass index	Weight and height will be combined to report BMI in kg/m^2	16 weeks
Secondary	Neck circumference	Assessed by anthropometric techniques	16 weeks
Secondary	Blood Pressure (mmHg)	Systolic and diastolic blood pressure measured with digital sphygmomanometer	16 weeks
Secondary	Physical activity	Physical activity will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.	16 weeks
Secondary	Sleep quality	Sleep quality will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.	16 weeks
Secondary	Perceived enjoyment of physical activity	Assessed by the Physical Activity Enjoyment Scale questionnaire (PACES). Raw scores are transformed into a scale from 16 to 80. Higher scores correspond to higher perceived enjoyment.	16 weeks