An interventional study of Supervised Aerobic Exercise Programme in Physical Inactivity, Overweight and Obesity, sponsored by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences · Not applicable, Interventional, and Basic science
This prospective, single-arm interventional study will investigate why adults receiving the same prescribed dose and relative intensity of exercise show divergent changes in energy balance, body weight, and body composition. A total of 150 sedentary Chinese adults aged 18-40 years with overweight or obesity will complete a 12-week, supervised treadmill exercise programme. Exercise will be performed five times per week at an intensity corresponding to 60% of each participant's measured maximal oxygen uptake. Prescribed exercise energy expenditure will increase progressively from 150 kcal per session in Weeks 1-4 to 250 kcal per session in Weeks 5-8 and 350 kcal per session in Weeks 9-12.
The primary objective is to quantify inter-individual variability in energy compensation after the standardized intervention. Detailed measurements will characterize total and resting energy expenditure, energy intake, appetite, physical activity, body composition, glucose dynamics, cardiorespiratory fitness, brain responses to food-related stimuli, and molecular phenotypes. Multi-omics analyses will include gut microbiome, metabolomic, proteomic, extracellular-vesicle, peripheral blood mononuclear cell, and transcriptomic assessments. The study will explore physiological, behavioral, and molecular factors associated with divergent compensatory responses. No randomized comparator group is included; therefore, causal comparisons between exercise and non-exercise conditions are outside the study scope.
Background and rationale
Individuals differ markedly in body-weight and fat-mass responses to apparently equivalent exercise programmes. This variability may reflect compensatory adaptations in other components of energy balance, including changes in non-exercise physical activity, resting energy expenditure, dietary energy intake, appetite, substrate metabolism, and neurobehavioral responses to food. Molecular and microbial phenotypes may further contribute to these divergent responses. A standardized intervention combined with detailed longitudinal phenotyping can identify response patterns and generate candidate predictors of energy compensation.
Study objectives
Primary objective:
To quantify inter-individual variability in energy compensation from baseline to the end of a 12-week supervised exercise intervention.
Secondary objectives:
Study procedures
After screening and written informed consent, eligible participants will undergo baseline assessments. These may include anthropometry, body composition, dual-energy X-ray absorptiometry, magnetic resonance imaging, indirect calorimetry, maximal oxygen uptake testing, doubly labeled water assessment, respiratory-chamber assessment, continuous glucose monitoring, standardized food-intake and appetite assessments, physical-activity monitoring, functional magnetic resonance imaging, electroencephalography, and biological sample collection.
Cardiovascular assessments may include 24-hour ambulatory blood pressure monitoring, resting electrocardiography, and peripheral endothelial function measured using EndoPAT. Arterial stiffness and peripheral arterial status may be assessed using brachial-ankle pulse wave velocity and the ankle-brachial index. Carotid vascular structure may be assessed using ultrasonography. Cardiac structure, ventricular function, myocardial strain, and tissue characteristics may be evaluated using transthoracic echocardiography and cardiac magnetic resonance imaging.
Core body temperature, tympanic temperature, and ambient temperature will be continuously monitored using an e-Celsius ingestible capsule, a VitThermo in-ear monitor, and an iButton temperature logger, respectively.
Participants will then complete a 12-week supervised treadmill exercise intervention. Each session will be prescribed at 60% of the participant's measured maximal oxygen uptake. Exercise duration will be adjusted to achieve the prescribed energy expenditure. The prescribed dose will be 150 kcal per session during Weeks 1-4, 250 kcal per session during Weeks 5-8, and 350 kcal per session during Weeks 9-12. Participants will complete five supervised sessions per week. Cardiorespiratory fitness will be reassessed at prespecified intervals, allowing workload adjustment to maintain the intended relative exercise intensity.
Selected assessments will be repeated at prespecified interim visits, at the completion of the intervention in Week 12, and during the follow-up assessment in Week 24. Blood, urine, and fecal samples will be collected at designated time points.
Biological samples may undergo microbiome, metabolomic, proteomic, extracellular-vesicle, peripheral blood mononuclear cell, bulk RNA-sequencing, and selected single-cell RNA-sequencing analyses. These analyses will be exploratory and interpreted using appropriate multiple-testing correction and validation procedures.
367 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 314 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences is the lead sponsor of 22 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
All enrolled participants will receive the same progressive, 12-week supervised treadmill exercise programme. The relative exercise intensity will be standardized at 60% of measured maximal oxygen uptake, Actual intensity will be also tested during the first interventional session of each month, while session duration will be individualized to achieve the prescribed energy expenditure.
Behavioral: Supervised Aerobic Exercise Programme
Participants will perform supervised treadmill exercise five days per week for 12 weeks. Each session will be conducted at 60% of the participant's measured maximal oxygen uptake. The prescribed exercise energy expenditure will be 150 kcal per session in Weeks 1-4, 250 kcal per session in Weeks 5-8, and 350 kcal per session in Weeks 9-12. Session duration will be adjusted individually to meet the energy-expenditure target. Maximal oxygen uptake will be reassessed at prespecified intervals, provisionally at baseline and Weeks 4, 8, and 12, to maintain the prescribed relative intensity. Attendance, completed exercise dose, heart rate, adverse symptoms, and protocol deviations will be documented. 150 Kcal for Weeks 1-4 (gradually increase to 150 Kcal in the first two weeks as familiar stage), 250 Kcal for Weeks 5-8, 350 Kcal for Weeks 9-12.
Also known as: Exercise training; treadmill exercise; aerobic training
Energy compensation after the 12-week supervised exercise intervention
Exercise energy compensation (ExEC), expressed in percentage, will be calculated as \[(ExEE plus change in body energy stores) divided by ExEE\] multiplied by 100. ExEE will be calculated from completed supervised exercise sessions. Change in body energy stores will be derived from changes in fat mass and fat-free mass between baseline and Week 12 and divided by the intervention duration. A value of 0% indicates no compensation, whereas 100% indicates complete compensation for the exercise-induced energy expenditure.
Time frame: Baseline to Week 12
Change in body weight
Difference in measured body weight in kilograms relative to baseline.
Time frame: Weekly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).
Change in body composition
Difference in body composition will be measured by the prespecified body-composition method. Dual-energy X-ray absorptiometry will be used for the principal endpoint if confirmed; bioelectrical impedance will be used for interim monitoring. Changes in abdominal subcutaneous adipose tissue, visceral adipose tissue, organ-specific fat depots, and the volume or size of prespecified organs will be quantified using magnetic resonance imaging.Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in energy expenditure
Difference in average daily total energy expenditure will be measured using doubly labeled water. Changes in 24-hour energy expenditure, sleeping energy expenditure, resting energy expenditure, and the thermic effect of food will be measured by whole-room indirect calorimetry in a human metabolic chamber. Exercise energy expenditure and excess post-exercise oxygen consumption (EPOC) will be assessed by indirect calorimetry using a COSMED. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in ad libitum energy intake
Difference in energy intake, measured during the free-living conditions and laboratory meal assessment. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in hunger rating
Hunger will be assessed using a 100-mm visual analogue scale in response to the question "How hungry do you feel?" The scale is anchored by "I am not hungry at all" at 0 mm and "I have never been more hungry" at 100 mm. The distance from the left end of the scale to the participant's mark will be measured in millimeters. The mean of all valid hunger ratings collected during each assessment period will be calculated. Higher scores indicate greater perceived hunger. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in neural responses to food-related stimuli
Neural activation characteristics of reward-related and energy homeostasis-regulating brain regions during the selection of foods with varying energy densities and macronutrient compositions, assessed by fMRI and EEG.Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in maximal oxygen uptake
Maximal oxygen uptake will be measured during a graded treadmill exercise test using a respiratory gas-analysis system. Relative maximal oxygen uptake will be expressed in mL/kg/min. Changes at each post-baseline assessment will be evaluated relative to baseline.
Time frame: Monthly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).
Change in free-living physical activity
Difference in accelerometer-derived physical activity using prespecified valid-wear criteria. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean interstitial glucose
Mean interstitial glucose will be calculated over the valid continuous glucose monitoring period and expressed in mmol/L. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean amplitude of glycemic excursions
The mean amplitude of glycemic excursions (MAGE) will be calculated from valid continuous glucose monitoring data and expressed in mmol/L. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in glucose coefficient of variation
The glucose coefficient of variation will be calculated as the standard deviation of glucose divided by mean glucose and multiplied by 100. It will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in resting blood pressure
Resting blood pressure will be measured in mmHg using electronic blood pressure monitor sphygmomanometer and watch after 10 minutes of rest and after both the energy consumption test and the endurance test. Changes at Week 4,8,12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in 24 hours ambulatory blood pressure
Blood pressure will be measured using a blood pressure monitor. Systolic and diastolic blood pressure during the daytime and nighttime will be calculated from valid blood pressure readings and expressed in millimeters of mercury (mmHg). Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in reactive hyperemia index
Vascular endothelial function will be assessed using EndoPAT by measuring changes in peripheral arterial tone during reactive hyperemia. The reactive hyperemia index (RHI) will be calculated automatically using the device-specific algorithm and expressed as a ratio. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in arterial stiffness
Arterial stiffness will be assessed non-invasively by measuring brachial-ankle pulse wave velocity (baPWV). baPWV will be calculated as the estimated arterial path length divided by pulse transit time and expressed in meters per second (m/s). Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in carotid vascular structure
Carotid vascular structure will be assessed non-invasively using carotid ultrasonography. Carotid intima-media thickness (CIMT) will be measured as the distance between the lumen-intima and media-adventitia interfaces of the carotid artery wall and expressed in millimeters (mm). Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in cardiac electrical activity
Resting cardiac electrical activity will be assessed using an electrocardiographic monitoring device. Electrocardiographic parameters, including PR interval, QRS duration and QT interval will be derived from recorded ECG signals and expressed in milliseconds (ms) for ECG intervals. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume (LVEDV) will be measured using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular End-Systolic Volume (LVESV)
Left ventricular end-systolic volume (LVESV) will be measured using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Stroke Volume (LVSV)
Left ventricular stroke volume (LVSV) will be calculated as the difference between left ventricular end-diastolic and end-systolic volumes obtained using cardiac magnetic resonance (CMR) cine imaging and expressed in milliliters (mL).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction (LVEF) will be calculated as the difference between end-diastolic volume (EDV) and end-systolic volume (ESV), divided by EDV and multiplied by 100. EDV and ESV will be obtained using cardiac magnetic resonance (CMR) cine imaging. LVEF will be expressed as a percentage (%).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Myocardial Mass
Left ventricular myocardial mass will be quantified using cardiac magnetic resonance (CMR) cine imaging and expressed in grams (g).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular Global Longitudinal Strain (GLS)
Left ventricular global longitudinal strain (GLS) will be assessed using feature-tracking analysis of cardiac magnetic resonance (CMR) cine images and expressed as a percentage (%).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Myocardial Native T1 Relaxation Time
Myocardial native T1 relaxation time will be measured using cardiac magnetic resonance (CMR) T1 mapping sequences and expressed in milliseconds (ms).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Myocardial T2 Relaxation Time
Myocardial T2 relaxation time will be measured using cardiac magnetic resonance (CMR) T2 mapping sequences and expressed in milliseconds (ms).Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Left Ventricular E/e' Ratio
The ratio of early mitral inflow velocity (E) to the average early diastolic mitral annular velocity (e') will be measured using transthoracic echocardiography (TTE) with Doppler imaging and reported as a dimensionless value. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Adherence to the exercise intervention
Number and percentage of prescribed sessions completed and percentage of prescribed exercise energy expenditure achieved.
Time frame: From the first exercise session through Week 12
Change in body circumferences
Changes in whole body circumferences will be quantified in centimeters using a three-dimensional body scanner. Changes in each measured circumference will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in heart rate and heart rate variability
Changes in heart rate and heart rate variability will be assessed using the prespecified wearable monitoring devices. Resting, exercise, post-exercise, and free-living heart rate will be expressed in beats per minute. Prespecified time-domain and frequency-domain heart rate variability indices will be derived from valid interbeat-interval recordings. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, during the 12-week intervention, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in total fatigue assessment scale score
Fatigue will be assessed using the 10-item Fatigue Assessment Scale (FAS). Each item evaluates how frequently the participant usually experiences a fatigue-related symptom and is rated on a 5-point scale: 1 (never), 2 (sometimes), 3 (regularly), 4 (often), and 5 (always). Items 4 and 10 will be reverse-scored. The 10 item scores will be summed to produce a total score ranging from 10 to 50, with higher scores indicating greater fatigue. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in energy rating
Momentary overall energy will be assessed using Item 1 of the Daytime Energy Data Collection Momentary Energy Questionnaire. Participants will rate their current overall energy level on a 7-point scale ranging from 1 (completely drained) to 7 (peak state). The mean of all valid ratings collected during each assessment period will be calculated. Higher scores indicate a higher perceived energy level. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Changes in the global score and prespecified component scores will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in average nightly sleep efficiency measured by actigraphy
Sleep will be monitored using an ActiGraph GT3XP-BTLE triaxial accelerometer. Sleep efficiency will be calculated as total sleep time divided by time in bed and multiplied by 100. The average sleep efficiency across all valid monitoring nights during each assessment period will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Fourteen-day monitoring periods at baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in average sleep efficiency measured using the ISHO ring
Sleep will be monitored using the ISHO ring. Sleep efficiency will be calculated using the device-specific algorithm as total sleep time divided by time in bed and multiplied by 100. The average sleep efficiency across all valid monitoring nights during each assessment period will be expressed as a percentage. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Throughout from baseline to Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).
Change in MRI-derived slow-twitch muscle fiber proportion in the soleus
The proportion of slow-twitch muscle fibers in the soleus will be estimated using the prespecified magnetic resonance imaging. The slow-twitch muscle fiber proportion will be expressed as a percentage of the assessed soleus muscle tissue. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in MRI-derived slow-twitch muscle fiber proportion in the gastrocnemius
The proportion of slow-twitch muscle fibers in the gastrocnemius will be estimated using the prespecified magnetic resonance imaging. The slow-twitch muscle fiber proportion will be expressed as a percentage of the assessed gastrocnemius muscle tissue. Changes at Week 12 and Week 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean core body temperature
Core body temperature will be continuously measured using an ingestible e-Celsius temperature capsule (BodyCap). Recording will begin after the capsule reaches the gastrointestinal tract. The mean of all valid temperature readings collected during each monitoring period will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C).
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean tympanic temperature
Tympanic temperature will be continuously measured using a VitThermo (SKINOS, VTB-01) temperature monitor. The mean of all valid temperature readings collected during each monitoring period will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C).
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in mean ambient temperature exposure
Ambient temperature exposure will be measured using an iButton (DS1921G). The device will record the temperature of the participant's surrounding environment during each monitoring period. The mean of all valid temperature readings will be calculated. Changes at Week 12 and Week 24 will be assessed relative to baseline and expressed in degrees Celsius (°C).
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in gut microbiome
Identify gut microbiota species altered by exercise training using advanced metagenomics.Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in metabolomics
Changes in metabolites will be measured using metabolomic analyses. Metabolite abundance will be compared between baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in circulating proteomic profiles
Changes in the abundance of prespecified circulating proteins and protein-related pathways will be assessed in plasma or serum using the prespecified proteomic platform. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in circulating extracellular-vesicle molecules
Changes in extracellular-vesicle molecules will be assessed using plasma samples.Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in peripheral blood mononuclear cell composition and molecular characteristics
Changes in the relative abundance of prespecified peripheral blood mononuclear cell populations and their molecular characteristics will be assessed using immunophenotyping and molecular profiling.Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in bulk transcriptomic profiles
Changes in gene-expression profiles and prespecified biological pathways will be assessed by bulk RNA sequencing of PBMC. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Change in single cell transcriptomic profiles
Changes in single cell gene expression signatures will be assessed using single-cell RNA sequencing in a prespecified participant subset. Changes at Week 12 and 24 will be assessed relative to baseline.
Time frame: Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).
Start is estimated for Oct 2026; primary completion for Dec 2029, 38 months later.
Of 243 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 38 months is above that.
Counting every sponsor, half of 246 studies reached it within 22 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences