Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 021, China
Location status: Recruiting
NCT Number: NCT06416488
This study aims to evaluate the health promotion effects of high-intensity interval training (HIIT) intervention on school-age children who are at high risk for cardiovascular disease (CVD), as well as the long-term adherence and acceptability of HIIT in this population for future application.
Interested in participating?
Request Info7 year–18 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 021, China
Location status: Recruiting
Evidence shows that physical activity is positively associated with cardiovascular and metabolic health in children and adolescents, including promoting lipid health, regulating blood pressure levels, and glucose metabolism. Physical activity intervention for overweight or obese children can lower body mass index, total fat mass, and abdominal fat mass, and further prevent chronic diseases such as cardiovascular and metabolic diseases. High-intensity interval training (HIIT) has been a recent research focus. Previous studies have demonstrated that HIIT can contribute to improving body composition, reducing visceral fat, and enhancing cardiovascular and pulmonary function. Moreover, compared to other trainings, HIIT is time-efficient and adaptable to various sports, thus leading to higher compliance.
However, there has been a lack of evidence regarding the intervention effects of this exercise in overweight and obese children and adolescents, and whether it can impact or even reverse cardio-metabolic risks remains unknown.
Therefore, this intervention trial might have implications and practical significance on the feasibility of promoting HIIT among this population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Modified HIIT in Tabata mode, which followed a pattern of 3 sets, with each set consisting of 4 repetitions of 20 seconds of high-intensity exercise followed by 10 seconds of rest, at least 3 times per week.
General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants.
Time frame: 3rd month since baseline
The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 3rd month of study phrase.
Reversal of cardiometabolic abnormalities is defined as: at 3rd month of study phrase, at least one of the following status changed from abnormal at baseline to normal:
i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.
Time frame: 12th month since baseline
It is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 12th month of study phrase.
Reversal of cardiometabolic abnormalities is defined as: at 12th month of study phrase, at least one of the following status changed from abnormal at baseline to normal:
i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.
Time frame: 3rd and 12th month since baseline
Body mass index(BMI) will be calculated by body weight(kg)/(height(m)^2), based on BMI z score and percentiles by sex and age according to Chinese children growth curves. Body weight and height will be measured by trained professionals.
Time frame: 3rd and 12th month since baseline
Waist-to-height ratio(WHtR) will be calculated by waist circumference(cm)/height(cm). Waist circumference and height will be measured by trained professionals.
Time frame: 3rd and 12th month since baseline
Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator.
Time frame: 3rd and 12th month since baseline
Average amount of calories(kcal) when at complete rest (2 hours after meals), measured by a Parvo Medics TrueOne 2400 mask to measure exchanges of gases.
Time frame: 3rd and 12th month since baseline
Maximal oxygen uptake(VO2max) will be measured by a Parvo Medics TrueOne 2400 mask after treadmill (Pulsar 4.0,h/p/Cosmos Sports and Medical GMBH , Germany).
Time frame: 3rd and 12th month since baseline
Sleep quality monitoring for 1 week using sleep watch (Micro Motionlogger Watch)to measure total duration of sleeping (minutes).
Contact information is provided by the study sponsor or research team.
Children's Hospital of Fudan University
Other
The Effect of High-Intensity Interval Training(HIIT) on Cardio-metabolic Indicators in School-age Children With High Cardiovascular Diseases Risk--a Randomised Intervention Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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