The objective of this observational study is to integrate the doubly labeled water (DLW) database from healthy individuals with multimodal data-including, but not limited to, weight, height, age, sex, race, elevation-from cohorts undergoing rehabilitation following movement impairments or neurological injuries. Machine learning algorithms will be used to develop injury-specific predictive models of energy requirements. The primary research question is: How does energy metabolism change during the rehabilitation process in individuals recovering from traumatic brain injury, stroke, or major surgical procedures? To answer this, participants will undergo a comprehensive set of assessments, including measurements of height and weight, body composition, resting metabolic rate, physical activity levels, total energy expenditure, psychological health, food intake and hunger ratings, sleep quality, cognitive performance, non-invasive brain function monitoring, and gait analysis. Fecal and blood samples will also be collected for untargeted metabolomics analysis.
1. Body Weight and Height Participants will fast overnight prior to measurement. Body weight will be measured in the morning using a calibrated Seca digital scale, with participants wearing light clothing and no shoes. Height will be measured using a Seca 217 stadiometer, with participants standing barefoot. 2. Resting Energy Expenditure (REE) REE will be measured via indirect calorimetry using a respiratory hood system (Cosmed). Participants will report to the laboratory after an overnight fast, lie supine on a flat bed, and have the hood placed over their head. Oxygen consumption and carbon dioxide production will be recorded for 40 minutes, with the final 10 minutes used for analysis. The system will be quality-checked regularly using a turbine test, and monthly validation will be conducted via an alcohol combustion test. 3. Total Energy Expenditure (TEE) TEE will be assessed using two complementary methods: Doubly Labeled Water (DLW) Method: Urine samples from the DLW subset will be stored at -20 °C and shipped on dry ice to Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences. Isotope ratios will be analyzed using a Liquid Water Isotope Analyzer (ABB). CO₂ production will be calculated using the latest equation from Speakman et al. (2021, Cell Reports Medicine), and TEE will be estimated using the Weir equation. Metabolic Chamber: TEE will also be measured using a whole-body metabolic chamber (Maastricht Instruments, Netherlands), which continuously tracks oxygen consumption and carbon dioxide production. Participants will remain in the chamber for 48 hours, engaging in routine daily activities. Data from the second day will be analyzed to estimate TEE. 4. Physical Activity Physical activity will be assessed using a GT3X accelerometer worn on the hip for 15 consecutive days. The device should not be worn during bathing or swimming. Data from the first day and any day with \<12 hours of wear time will be excluded. A valid dataset requires at least two weekdays and two weekend days of usable data. 5. Body Composition Body composition will be measured using the following techniques: Magnetic Resonance Imaging (MRI; Philips Multiva 1.5T) Dual-energy X-ray Absorptiometry (DXA; HOLOGIC Horizon Wi, USA) Bioelectrical Impedance Analysis (BIA; TANITA MC-980, Japan) Parameters to be assessed include total and regional fat mass, lean mass, and fat percentage across the limbs and trunk. MRI will be used for whole-body fat distribution analysis by trained technicians. 6. Mental Health Assessment The Symptom Checklist-90 (SCL-90) will be used to evaluate psychological well-being. This tool measures ten dimensions: somatization, obsessive-compulsive traits, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoid ideation, psychosis, and additional symptoms. Scores for each dimension and overall symptom severity will be calculated. 7. Food Intake and Hunger Assessment Meals will be designed based on the energy distribution guidelines from the Chinese Dietary Guidelines. After a standardized lunch, participants will receive a test meal (packaging removed) containing predefined macronutrient and energy levels five hours later. Food intake will be ad libitum, and hunger levels will be assessed based on behavioral indicators. Blood samples (4 mL) will be collected at baseline (pre-dinner), and 15, 30, and 60 minutes post-dinner for appetite-related hormones analysis such as ghrelin and PYY. 8. Sleep Quality Monitoring Sleep will be monitored using the Heartcare Youhu Pro AI Precision Health Management System, which tracks total sleep duration, sleep efficiency, cycle durations, heart rate, and respiratory patterns. These metrics will be used to assess sleep quality. 9. Cognitive Function Assessment Cognitive performance will be evaluated using: Mini-Mental State Examination (MMSE): Assesses orientation, memory, attention, language, and visuospatial function. Scores of 25-30 indicate normal function; 20-24 mild, 10-19 moderate, and \<10 severe cognitive impairment. Montreal Cognitive Assessment (MoCA): Screens for impairment across eight cognitive domains. A score ≥26 is considered normal. 10. Non-Invasive Brain Function Monitoring Functional Near-Infrared Spectroscopy (fNIRS) will be used to assess brain activity by measuring changes in oxyhemoglobin and deoxyhemoglobin concentrations. We may use the BS2000 near-infrared imaging system for this purpose. Assessment Areas: Prefrontal cortex, motor cortex, frontal pole, dorsolateral prefrontal cortex, primary motor/somatosensory cortex, premotor and supplementary motor cortex-on both healthy and affected sides. Key Indicators:HbO, HbR, and HbT concentration changes during a 0-40 sec task window. 3D topological maps (HbO beta values). Activation levels at rest. Functional connectivity (HbO). 11. Gait Analysis Laboratory A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for gait analysis. This non-invasive system captures: Spatiotemporal Parameters: Step time, frequency, speed, stride length/width, and symmetry Kinematic Parameters: Joint angles (pelvis, hip, knee), motion curves, ground reaction forces, and joint torques 12. Gut Microbiota and Blood Metabolomics Mid-portion fecal samples and 5 mL blood samples will be collected. Fecal samples will undergo non-targeted microbiome analysis at Novogene, while blood samples will be analyzed at Biotree Bioscience for metabolomic profiling, including appetite-related hormones such as ghrelin and PYY.
Study Type
OBSERVATIONAL
Enrollment
80
Guangdong Jianxiang Hospital Group
Foshan, Guangdong, China
RECRUITINGHeight
Measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Time frame: Height will be measured on the first day after volunteers are enrolled.
Resting Energy Expenditure (REE)
REE will be measured via indirect calorimetry using a respiratory hood system (Cosmed). Participants will report to the laboratory after an overnight fast, lie supine on a flat bed, and have the hood placed over their head. Oxygen consumption and carbon dioxide production will be recorded for 40 minutes, with the final 10 minutes used for analysis. The system will be quality-checked regularly using a turbine test, and monthly validation will be conducted via an alcohol combustion test.
Time frame: The measurement of REE will be completed within fifteen days after the volunteers are enrolled.
Total Energy Expenditure (TEE)
TEE will be assessed using two complementary methods: Doubly Labeled Water (DLW) Method: Urine samples from the DLW subset will be stored at -20 °C and shipped on dry ice to Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences. Isotope ratios will be analyzed using a Liquid Water Isotope Analyzer (ABB). CO₂ production will be calculated using the latest equation from Speakman et al. (2021, Cell Reports Medicine), and TEE will be estimated using the Weir equation. Metabolic Chamber: TEE will also be measured using a whole-body metabolic chamber (Maastricht Instruments, Netherlands), which continuously tracks oxygen consumption and carbon dioxide production. Participants will remain in the chamber for 48 hours, engaging in routine daily activities. Data from the second day will be analyzed to estimate TEE.
Time frame: The measurement of TEE will be completed within fifteen days after the volunteers are enrolled.
Physical Activity Level
During the measurement period, all participants will be required to wear a three-axis accelerometer (Actigraph GT3XP-BTLE, USA) for 15 days, covering 24 hours a day, including sleep. Participants can remove the accelerometer only when showering, bathing, swimming, or engaging in other water activities. This device will provide multiple parameters of physical activity levels, including raw acceleration data, activity counts, and vector magnitudes. Raw acceleration data captures subtle changes in individual movements, activity counts measure the intensity of physical activity over specific time periods, and vector magnitudes integrate acceleration information from all directions. These three indicators were used to comprehensively evaluate participants' physical activity levels.
Time frame: GT3X will be worn by the volunteers on the first day of enrollment and continue for fifteen days.
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Philips Multiva 1.5T ).
Time frame: Fat mass will be completed within fifteen days after the volunteers are enrolled.
Mental Health Assessment
The Symptom Checklist-90 (SCL-90) will be used to evaluate psychological well-being. This tool measures ten dimensions: somatization, obsessive-compulsive traits, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoid ideation, psychosis, and additional symptoms. Scores for each dimension and overall symptom severity will be calculated.
Time frame: Mental health assessment will be completed within fifteen days after the volunteers are enrolled.
Cognitive Function Assessment
Cognitive performance will be evaluated using: Mini-Mental State Examination (MMSE): Assesses orientation, memory, attention, language, and visuospatial function. Scores of 25-30 indicate normal function; 20-24 mild, 10-19 moderate, and \<10 severe cognitive impairment.
Time frame: Cognitive function assessment will be completed within fifteen days after the volunteers are enrolled.
Fat free mass
Fat free mass will be measured by Bioimpedance Analysis (Tanita, Philips Multiva 1.5T).
Time frame: Fat free mass will be completed within fifteen days after the volunteers are enrolled.
Body weight
Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes. .
Time frame: Body weight will be measured on the first day after volunteers are enrolled.
Cognitive Function Assessment
Cognitive performance will be evaluated using: Montreal Cognitive Assessment (MoCA): Screens for impairment across eight cognitive domains. A score ≥26 is considered normal.
Time frame: Cognitive function assessment will be completed within fifteen days after the volunteers are enrolled.
Bone mass
Bone mass will be measured by DXA (HOLOGIC Horizon Wi，America）
Time frame: Bone mass will be completed within fifteen days after the volunteers are enrolled.
Hunger Sensation
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, with its packaging removed, includes preset macro-nutrient and energy levels, allowing participants to determine their intake. Hunger sensation will be assessed using a VAS (Visual Analog Scale) for hunger.
Time frame: Hunger sensation assessment will be completed within fifteen days after the volunteers are enrolled.
PYY
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, which has been removed from its packaging, includes preset macronutrient and energy levels, allowing participants to determine their intake. Blood samples are collected at 15,30, and 60 minutes before dinner, after dinner, and again before bedtime, with each sample being 2ml (a total of four times, with a permanent indwelling needle). PYY is detected through these blood samples.
Time frame: PYY will be measured within fifteen days after the volunteers are enrolled.
Ghrelin
After enjoying a standardized lunch, designed according to the energy distribution recommendations and formula method outlined in the Chinese Dietary Guidelines, participants will receive a test meal five hours later. The meal, which has been removed from its packaging, includes preset macronutrient and energy levels, allowing participants to determine their intake. Blood samples are collected at 15,30, and 60 minutes before dinner, after dinner, and again before bedtime, with each sample being 2ml (a total of four times, with a permanent indwelling needle). Ghrelin is detected through these blood samples.
Time frame: Ghrelin will be measured within fifteen days after the volunteers are enrolled.
Total Sleep Duration
Total sleep duration will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Time frame: Total sleep duration will be completed within fifteen days after the volunteers are enrolled.
Sleep Efficiency
Sleep efficiency will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Time frame: Sleep efficiency will be completed within fifteen days after the volunteers are enrolled.
Sleep Cycle Durations
Sleep cycle durations will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Time frame: Sleep cycle durations will be completed within fifteen days after the volunteers are enrolled.
Heart Rate During Sleep
Heart rate during sleep will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Time frame: Heart rate during sleep will be completed within fifteen days after the volunteers are enrolled.
Respiratory Patterns During Sleep
Respiratory patterns during sleep will be monitored using the Xinxiaoyouhu Pro AI Precision Health Management System.
Time frame: Respiratory patterns during sleep will be completed within fifteen days after the volunteers are enrolled.
Step Time
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step time.
Time frame: Step time will be completed within fifteen days after the volunteers are enrolled.
Step Frequency
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step frequency.
Time frame: Step frequency will be completed within fifteen days after the volunteers are enrolled.
Step Speed
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for step speed.
Time frame: Step speed will be completed within fifteen days after the volunteers are enrolled.
Stride Length
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for stride length.
Time frame: Stride length will be completed within fifteen days after the volunteers are enrolled.
Bilateral Gait Symmetry
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for bilateral gait symmetry.
Time frame: Bilateral gait symmetry will be completed within fifteen days after the volunteers are enrolled.
Pelvic, Hip and Knee Joint Angle Parameters
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for pelvic, hip and knee joint angle parameters.
Time frame: Pelvic, hip and knee joint Angle parameters will be completed within fifteen days after the volunteers are enrolled.
Joint Torque
A 3D markerless motion capture system (Xiangneng-Dongxi) will be used for joint torque.
Time frame: Joint torque will be completed within fifteen days after the volunteers are enrolled.
Non-Targeted Microbiome Detection Of Stool Samples
Non-targeted microbiome studies are a comprehensive and unbiased approach to studying microbial communities. This method uses high-throughput sequencing or mass spectrometry to analyze the genomes (metagenomics) or metabolites (metabolomics) of all microorganisms in a sample, without preconceived targets. Since this study does not have a specific target microorganism, we will collect approximately 10ml of midstream fecal samples from participants for the detection of all microorganisms' genomes (metagenomics) or metabolites (metabolomics).
Time frame: The retention of stool samples for non-targeted microbiome detection will be completed within 15 days after the enrollment of volunteers, and the sample analysis will be completed before November 1, 2025.
Non-Invasive Brain Function Monitoring
Functional Near-Infrared Spectroscopy (fNIRS) will be used to assess brain activity by measuring changes in oxyhemoglobin and deoxyhemoglobin concentrations. We may use the BS2000 near-infrared imaging system for this purpose. Assessment Areas: Prefrontal cortex, motor cortex, frontal pole, dorsolateral prefrontal cortex, primary motor/somatosensory cortex, premotor and supplementary motor cortex-on both healthy and affected sides. Key Indicators:HbO, HbR, and HbT concentration changes during a 0-40 sec task window. 3D topological maps (HbO beta values). Activation levels at rest. Functional connectivity (HbO).
Time frame: Non-invasive brain function monitoring will be completed within fifteen days after the volunteers are enrolled.
Cerebral Oxyhemoglobin Concentration
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured cerebral oxyhemoglobin concentration.
Time frame: Cerebral oxyhemoglobin concentrationn will be completed within fifteen days after the volunteers are enrolled.
Cerebral Deoxyhemoglobin Concentration
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured cerebral deoxygenated concentration.
Time frame: Cerebral deoxyhemoglobin concentration will be completed within fifteen days after the volunteers are enrolled.
Total Hemoglobin Concentration In Cerebral Vasculature
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measured total hemoglobin concentration in cerebral vasculature
Time frame: Total hemoglobin concentration in cerebral vasculature will be completed within fifteen days after the volunteers are enrolled.
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