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Набор скоро начнётся NCT06205563

The Therapeutic Effect of Different Exercise Intensities on Weight Loss in Obese Children

Без фазы С лечением Weight Loss Obese Children and Adolescents

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: high-intensity interval training, moderate intensity continuous training.
Кому может быть актуально
Состояния в реестре: Weight Loss, Obese Children and Adolescents. Базовые параметры: 6 лет — 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effects of Short-term Supervised High-intensity Interval Training and Moderate Intensity Continuous Training on Weight Loss and Metabolic Indicators in Obese Children Under Energy Limited Balanced Diet

Обзор

The incidence of childhood obesity is increasing, followed by metabolic diseases related to overweight and obesity in children. High intensity interval training (HIIT) has recently been shown to improve the body composition and cardiovascular health of obese children. Currently, there is little evidence on the impact of exercise intensity on endocrine and metabolic indicators and quality of life in obese children. The main purpose of this study is to compare the effects of short-term supervised high-intensity interval training and moderate intensity continuous training (MICT) on metabolic indicators in obese children under an energy limited balanced diet. A multicenter prospective randomized controlled trial was conducted on 388 obese children in South China. The experimental group will be randomly assigned to (1) HIIT and energy limited balanced diet, and (2) MICT and energy limited balanced diet. The experimental group will participate in a 3-month (supervised) exercise training. The measurement of the study endpoint will be followed up at baseline, 3 months (after supervised intervention), 9 months, and 1 year. The primary endpoint is the percentage of weight loss (△ Wt%). Secondary endpoints include waist to height ratio, body mass index (BMI), body fat percentage, insulin resistance index (HOMA-IR), insulin secretion index (ISI), and Δ HtSDSBA. The results of this study will generate a wealth of information on the impact of exercise intensity on weight loss and endocrine metabolism in obese children, and develop more effective evidence-based exercise prescription guidelines in this population.

Вмешательства

  • Поведенческое high-intensity interval training
    High-intensity interval training (to significantly faster breathing, a significant increase in breathing depth, a significant increase in heart rate, sweating, and the need to stop exercising and adjust your breathing before you can speak; Energy expenditure (METy ≥6.00 in children) : Participants randomly assigned to HIIT will perform a 10-minute warm-up at 60-70% of their maximum heart rate (HRmax). After this, they will walk, run, or bike at 85-95% of their maximum heart rate for four session
  • Поведенческое moderate intensity continuous training
    Moderate intensity continuous training (rapid breathing, rapid heart rate, slight sweating, but still able to talk easily; Energy expenditure (children METy) 3.00 to 5.99) : Participants randomly assigned to the MICT group will walk, run, or cycle continuously for 40 minutes at 60-70% HRmax. Participants will be required to participate in supervised exercise classes at least five times and up to seven times a week for 12 weeks. Each participant will be free to wear a smart electronic sports brac

Первичные конечные точки

  • △Wt% [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

  • The guardian understands and signs the informed consent. If the subject is at least 8 years old, the informed consent must be signed.
  • Age 6\~16 years old, male and female;
  • BMI≥ \"sex-age BMI reference point for obesity screening of school-age children aged 6-18 years\";
  • no disability;
  • Joint cardiopulmonary function assessment showed that participation was safe;
  • At least one year of follow-up is expected.

Критерии исключения

  • Have high blood pressure (defined as systolic or diastolic blood pressure values above the 95th percentile), any history or evidence of heart disease and/or abnormal resting or stress echocardiography or a combined cardiopulmonary function assessment indicating that participation is not safe;
  • have any chronic disease, such as chronic asthma, kidney disease, type 1 diabetes, epilepsy, etc.;
  • suffering from organic diseases, such as ovarian tumors, hamartoma, etc.;
  • A smoking habit or orthopedic/neurological condition that may limit exercise ability;
  • Confirmed attention deficit hyperactivity disorder and steroid use.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06205563 · TOWL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗