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临床试验/NCT07008326
NCT07008326尚未招募不适用

Comparative Effects of High-Intensity Circuit Training and Moderate-Intensity Continuous Training on Various Health Parameters in Overweight Young Adults

Indonesia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
1
主要终点
Body Fat Percentage

研究概览

简要总结

The increasing prevalence of overweight and obesity is becoming a concern worldwide as it is associated with the increased prevalence of non-communicable diseases. One of the main reasons for this problem is that more adults did not fulfill the weekly physical activity recommendations, with the lack of time and motivation as the main factor. This study aims to compare the effectiveness of a high-intensity circuit training program and the more familiar moderate-intensity continuous training in improving body composition, cardiorespiratory fitness, lipid profile, oxidative stress, and inflammatory markers in young adult males. At the same time, it also explores its adherence through its enjoyment scale and gradual changes in supervision. This experimental study compares pre- and post-tests in the two groups. 3-days food records and 7-days physical activity will be measured monthly as the confounding factors.

详细描述

  • Participants will be recruited consecutively via online forms distributed throughout universities and networks across Jakarta and its surrounding area. Interested individuals will go through early screening. Eligible candidates will then complete an initial assessment at the research site.
  • Research assistants will use standard operational procedures for each assessment. The training for research assistants will be done before data collection. One group of research assistants are responsible for main outcome data collection. The researcher is responsible for data analysis. Continuous evaluations will be done weekly to improve the research process.
  • Sample size is measured from the 6-research outcomes using the sample size calculation formula for evaluating the mean difference between two variables in repeated measurements.
  • Eligible candidates who passed the initial assessment will be randomly divided into HICT (intervention) and MICT (control). The 12-week exercise program in both groups will change gradually in volume, intensity, and supervision. Both volume and intensity will be increased according to heart rate targets. Supervision will decrease gradually from fully supervised in the first 4 weeks, partially supervised in the second 4 weeks, and no supervision in the third 4 weeks.
  • Data will be collected and electronically recorded during each training session at the research site by the researcher and research assistants. This data includes time, heart rate, blood pressure, rating of perceived exertion (Borg Scale), training intensity, weight used, and enjoyment (PACES).
  • Subjects are encouraged to report any problem during intervention via online messaging or during on-site sessions to the research assistants. The reports will be documented in a separate form. The research assistant leading the data collection will ensure that no data is missing by performing daily checking.
  • Data collection for the main outcomes will be done by a different group of research assistants and will be masked from the intervention groupings.
  • Data analysis will be done using SPSS 26.0 by the researcher. The analysis will be started after baseline measurements are completed. We will present all normally distributed numeric data as mean and standard deviations and non-normally distributed numeric data as median and minimum-maximum range. Bivariate analysis of normally distributed data will be done using repeated 2-way ANOVA test or mixed linear model in case of many dropouts. If data is not distributed normally, the Friedman test will be used. Any missing data will be stated and completed immediately. Close supervision for each subject will be done by research assistance to ensure all necessary reports are collected and analysed.

研究设计

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

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Overweight (BMI 23-24.9 kg/m2)
  • •Physically inactive in the last 6 months before the study (<150 minutes of moderate-intensity activity and <75 minutes of high-intensity activity)
  • •Willing to participate in exercise program for 12 weeks
  • •No other exercise program during the study period

排除标准

  • •Medical comorbidities (diabetes mellitus, hypertension, cardiovascular disease, asthma, dyslipidaemia, epilepsy)
  • •History of musculoskeletal injuries or health problems related to exercise in the last 1 year
  • •Dropout Criteria
  • •Resigning
  • •Not participating in the endline assessment
  • •Not participating in the exercise program for 2 consecutive weeks
  • •Experiencing injury or health problems that led to the inability to participate in the program for 2 consecutive weeks

研究组 & 干预措施

High Intensity Circuit Training

Experimental

High Intensity Circuit Training, a bodyweight exercise program performed 3 times per week with increased intensity every 4 weeks

干预措施: High Intensity Circuit Training (Behavioral)

Moderate Intensity Continuous Training

Active Comparator

Moderate Intensity Continuous Training, brisk walk or jogging based exercise with increased intensity every 2-4 weeks

干预措施: Moderate Intensity Continuous Training (Behavioral)

结局指标

主要结局

Body Fat Percentage

时间窗: Week 0, 4, 8, 12

The total percentage of body fat mass measured by BIA Tanita MC-780 in %

Visceral Fat Mass

时间窗: Week 0, 4, 8, 12

Visceral fat mass measured by BIA Tanita MC-780 in kilograms

Malondialdehyde

时间窗: Week 0, 12

Malondialdehyde concentration in blood from whole blood samples measured in micromolar

Triglyceride

时间窗: Week 0, 12

Triglyceride concentration in blood measured in mg/dL

Superoxide dismutase

时间窗: Week 0, 12

Superoxide dismutase concentration in blood from whole blood sample measured in U/mL

Body Mass Index

时间窗: Week 0, 4, 8, 12

Weight and Height will be combined to report Body Mass Index in kg/m\^2

Total Cholesterol

时间窗: Week 0, 12

Total cholesterol in blood measured in mg/dL

High-Density Lipoprotein (HDL)

时间窗: Week 0, 12

HDL concentration in blood measured in mg/dL

Low-Density Lipoprotein (LDL)

时间窗: Week 0, 12

LDL concentration in blood measured in mg/dL

Tumor Necrosis Factor-alpha

时间窗: Week 0, 12

Tumor Necrosis Factor-alpha concentration in blood measured in pg/mL

Interleukin-6

时间窗: Week 0, 12

Interleukin-6 concentration in blood measured in pg/mL

Muscle Mass

时间窗: Week 0, 4, 8, 12

Muscle mass measured by BIA Tanita MC-780 in kilograms

Waist Circumference

时间窗: Week 0, 4, 8, 12

Waist circumference measured in centimeters

Cardiorespiratory Fitness

时间窗: Week 0, 12

VO2Max or VO2peak depends on the feasibility. The cardiac output (mL/min) and body weight (kg) will be combined in mL/kg. min

次要结局

  • Enjoyment(Up to 12 weeks)

研究者

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

Nani Cahyani Sudarsono

Dr. dr. Nani Cahyani Sudarsono, Sp.KO

Indonesia University

研究点 (1)

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