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临床试验/NCT06377137
NCT06377137已完成不适用

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

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Cardiorespiratory fitness

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Cardiorespiratory fitness

时间窗: 16 weeks

1-mile walk/run test; minutes to run 1 mile

Waist circumference

时间窗: 16 weeks

Anthropometric measurement of abdominal obesity; cm

次要结局

  • Variation in low-density lipoprotein cholesterol concentration (mg/dL)(16 weeks)
  • Hand grip strength(16 weeks)
  • Lower limb strength(16 weeks)
  • Blood Pressure (mmHg)(16 weeks)
  • Variation in HOMA-IR(16 weeks)
  • Variation in blood Alanine aminotransferase concentration (U/L)(16 weeks)
  • Body mass index(16 weeks)
  • Variation in high-density lipoprotein cholesterol concentration (mg/dL)(16 weeks)
  • Variation in serum insulin concentration (mU/L)(16 weeks)
  • Variation in blood triglycerides concentration (mg/dL)(16 weeks)
  • Variation in blood Gamma glutamyl transferase concentration (U/L)(16 weeks)
  • Body composition(16 weeks)
  • Variation in fasting blood glucose concentration (mg/dL)(16 weeks)
  • Variation in glycosylated hemoglobin concentration (mg/dL)(16 weeks)
  • Variation in total cholesterol concentration (mg/dL)(16 weeks)
  • Variation in blood Aspartate aminotransferase concentration (U/L)(16 weeks)
  • 6-minute walk test(16 weeks)
  • Neck circumference(16 weeks)
  • Physical activity(16 weeks)
  • Sleep quality(16 weeks)
  • Perceived enjoyment of physical activity(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hélder Fonseca

Assistant Professor

Universidade do Porto

研究点 (2)

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