- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377137
High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Porto, Portugal, 4200-450
- Faculty of Sport of the University of Porto
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Small-sided soccer games groups (SSSG)
SSSG will perform 16 weeks of training, 3 sessions/week, and ~55 minutes/session. Each session will begin with a 15-minute warm-up, 32 minutes of principal activity, and 5 minutes of cool down. The SSSG will consist of a program based on high-intensity SSSG. The training protocol is based on a pilot study conducted to characterize the exertion profile. The SSSG will be performed in a fractional regimen of 8 sets of 4 minutes and 2 minutes rest. The format of the SSGs will be 3v3, although they can be adapted to 2v2 or 4v4 when necessary. In addition, it will take place in a playing area of 9 x 18 meters equivalent to 27 square meters per player. To encourage high intensity, the following will be used (i) man-to-man marking; (ii) to score a goal, the entire team must be in the opponent's half of the field; (iii) balls will be available to reduce stoppages in play; (iv) the coach will motivate the team to maintain high intensity. |
Physical exercise intervention
|
|
Experimental: Traditional soccer training groups (TSG)
SSSG will perform 16 weeks of training, 3 sessions/week, and ~55 minutes/session. Each session will begin with a 15-minute warm-up, 32 minutes of principal activity, and 5 minutes of cool down. The TSG group will base its training on 30 minutes of technical exercises with the ball individually or in pairs (dribbling, shooting and passing), ending with 10 minutes of a match organized according to the original characteristics of an indoor soccer game. |
Physical exercise intervention
|
|
No Intervention: Control Group (CG)
CG will perform only regular school physical education classes without any additional intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist circumference
Time Frame: 16 weeks
|
Anthropometric measurement of abdominal obesity; cm
|
16 weeks
|
|
Cardiorespiratory fitness
Time Frame: 16 weeks
|
1-mile walk/run test; minutes to run 1 mile
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variation in fasting blood glucose concentration (mg/dL)
Time Frame: 16 weeks
|
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
|
|
Variation in serum insulin concentration (mU/L)
Time Frame: 16 weeks
|
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
|
|
Variation in HOMA-IR
Time Frame: 16 weeks
|
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
|
|
Variation in glycosylated hemoglobin concentration (mg/dL)
Time Frame: 16 weeks
|
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
|
|
Variation in high-density lipoprotein cholesterol concentration (mg/dL)
Time Frame: 16 weeks
|
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
|
|
Variation in low-density lipoprotein cholesterol concentration (mg/dL)
Time Frame: 16 weeks
|
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
|
|
Variation in total cholesterol concentration (mg/dL)
Time Frame: 16 weeks
|
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
|
|
Variation in blood triglycerides concentration (mg/dL)
Time Frame: 16 weeks
|
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
|
|
Variation in blood Alanine aminotransferase concentration (U/L)
Time Frame: 16 weeks
|
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
|
|
Variation in blood Aspartate aminotransferase concentration (U/L)
Time Frame: 16 weeks
|
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
|
|
Variation in blood Gamma glutamyl transferase concentration (U/L)
Time Frame: 16 weeks
|
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
|
|
6-minute walk test
Time Frame: 16 weeks
|
Distance covered walking in 6 minutes.
|
16 weeks
|
|
Hand grip strength
Time Frame: 16 weeks
|
Hand grip strength test measured with a digital hand dynamometer
|
16 weeks
|
|
Lower limb strength
Time Frame: 16 weeks
|
Assessed by Horizontal jump test.
|
16 weeks
|
|
Body composition
Time Frame: 16 weeks
|
Assessed by the electrical bioimpedance method
|
16 weeks
|
|
Body mass index
Time Frame: 16 weeks
|
Weight and height will be combined to report BMI in kg/m^2
|
16 weeks
|
|
Neck circumference
Time Frame: 16 weeks
|
Assessed by anthropometric techniques
|
16 weeks
|
|
Blood Pressure (mmHg)
Time Frame: 16 weeks
|
Systolic and diastolic blood pressure measured with digital sphygmomanometer
|
16 weeks
|
|
Physical activity
Time Frame: 16 weeks
|
Physical activity will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.
|
16 weeks
|
|
Sleep quality
Time Frame: 16 weeks
|
Sleep quality will be assessed objectively with a triaxial accelerometer used 24h/d during 7 consecutive days.
|
16 weeks
|
|
Perceived enjoyment of physical activity
Time Frame: 16 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of the Porto
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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