Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Pittsburgh Sleep Quality Index |
With subscale scores ranging from 0 to 3, the PSQI assesses subjective sleep quality in the previous month and consists of seven items (sleep duration, sleep latency, sleeping medications, sleep disturbance, daytime dysfunction, sleep quality, and sleep efficiency). The total score of the PSQI, ranging from 0 to 21, is the sum of subscale scores, and the higher the scores, the lower the subjective quality of sleep. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
Heart rate variability (HRV) |
HRV, a non-invasive method used to evaluate the autonomic nervous system modulation on the cardiac sinus node, describes the oscillations between consecutive electrocardiogram R-R intervals. High levels of HRV indices are generally signs of efficient autonomic mechanisms that characterise a healthy individual, while low or reduced HRV often show an autonomic nervous system malfunction and may imply health impairment. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
Flow-mediated dilation (FMD) |
Flow-mediated dilation (FMD) can assess endothelium-dependent vasodilation, evaluating vascular elasticity and dilation function. Its mechanism involves inducing reactive hyperemia, increasing arterial blood flow, leading to elevated shear stress on the vessel wall, prompting endothelial cells to release NO, resulting in vasodilation. A normal FMD value is =7%; values <4% indicate endothelial dysfunction. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
Cardiac Output (CO) |
Cardiac Output (CO) is a key indicator in echocardiographic examinations, used to measure the total volume of blood pumped by the heart per minute. This parameter reflects the efficiency of the heart's pumping action and the status of systemic blood circulation. The measurement of Cardiac Output is based on the volume of blood ejected by the heart with each beat (stroke volume) and the number of heartbeats per minute. Cardiac Output is typically expressed in liters per minute (L/min). |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
Intima-Media Thickness (IMT) |
Intima-Media Thickness (IMT) is a significant indicator measured through carotid ultrasound examination, used to assess the thickness of the carotid artery wall. The measurement of IMT focuses on the distance between the intima and media layers of the carotid artery, serving as a key indicator of early changes in atherosclerosis. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
The Berg Balance Scale(BBS) |
The BBS scale evaluates an individual's ability to maintain their balance while performing functional activities. It includes 14 items and each section is scored between 0 (worst) and 4 (best), and measures level of dependence/independence in positions such as standing from sitting, standing with feet together, standing in full balance position, balancing on one leg, as well as ability to change positions. High BBS score indicates good balance. Participants are classifed based on BBS score as high fall risk, balance disorder (0-20 points), moderate fall risk, acceptable balance (21-40 points), and low fall risk, good balance (41-56 points) |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
The 30-s Chair Stand Test |
In the 30-s CST, which assesses dynamic balance and physical ftness, the individual sits in the middle of a chair with seat height of 43 cm, with a straight back, feet fat on the foor, and arms crossed over the chest with hands at shoulder level. The test starts with the subject in this position at the "go" command. The number of times the patient rises to a full standing position without assistance in 30 s is recorded as the test score. A score of 5 indicates strength and 10 indicates both strength and endurance |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Primary |
Lower limb muscle strength test |
Using the micro FET3 (HOGGAN, USA) to test lower limb muscle strength. The main muscles tested include the tibialis anterior, triceps surae, quadriceps femoris, hamstrings, and iliopsoas. Each muscle is tested twice, and the maximum value is recorded |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Body Fat Percentage |
Body fat percentage refers to the proportion of body fat weight in the total body weight of the human body, which reflects the amount of fat content in the human body. Normal adult body fat percentage should be kept in a certain range. A high body fat percentage can be considered a criterion for obesity. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Finger-Ring Test |
The finger-ring test is an effective alternative to calf circumference, in which people encircle the thickest part of the non-dominant calf with the index fingers and thumbs of both hands, and are at an increased risk of developing sarcopenia if the measured calf fits just right or is turned smaller than their fingers. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Hand Grip Strength |
Grip strength is mainly a test of the degree of development of the upper limb muscle groups, testing the subject's forearm and hand muscle strength, reflecting the level of development of the human body's upper limb strength of an indicator. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Upper and Lower Body Flexibility |
Flexibility is often considered one of the most important components of physical fitness. It is often used to describe the range of motion of a single joint or a series of joints. Among the most commonly reported simple field tests of flexibility of the lower extremity have been sit and reach (SR) test. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
The SARC-F scale |
The SARC-F scale is a screening tool for muscle wasting disorders that has been developed in recent years to provide a rapid assessment of muscle strength and function without the need to rely on expensive instrumentation to measure muscle mass. SARC-F = 4 is defined as sarcopenia. The questions of SARC-F cover physical functions targeting sarcopenia or initial presentation for sarcopenia. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Shape Trail Test (STT) |
The Trail Making Test (TMT) scoring is expressed in terms of the time in seconds for Part A and Part B of the test. Some examiners also calculate a Trails B/Trails A ratio. The TMT is one of the most sensitive and popular tests for identifying mild cognitive impairment and mild dementia. It measures the speed for attention, sequencing, mental flexibility, and of visual search and motor function, mainly reflecting the ability of "set shifting".In China, the Shape Trail Test (STT) is more widely used. The STT was developed with the intent to minimize cultural bias and provide a more accurate cognitive measure in diverse populations.In the STT,Part B shows all numbers (from 1 to 25) twice, once in a circle and once in a square. The participants are asked to make lines alternating between circles and squares and disregarding the numbers of the alternate shapes.
The scoring of the STT has several indexes: (1) time in seconds required to complete each par |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
1-back Task more-odd shifting Task Stroop Task |
The 1-back task was used to explore the performance of different age groups on the memory updating task. subjects were used to investigate the relationship between physical activity and the executive function in the elderly by using the International Physical Activity Scale, 1-back Task, more-odd shifting Task and Stroop Task. E-Peime3.0 software was used to present the above paradigm, and SPSS20.0 software was used to analyze the response time and accuracy of the subjects. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Timed Up and Go |
The Timed up and go test (TUGT) was used to assess functional mobility. Participants were asked to walk at their ordinary walking speed during the tes t. They were seated at the beginning of the test and were asked to stand up from the chair, walk 3 m, turn around, return to the chair, and sit down again. The duration between rising from the chair and sitting down was measured with a stopwatch |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Close-eyed stepping in place |
Prepare to draw a 20 cm x 20 cm square on the ground with chalk. The subject is required to stand in the center of the square and, upon hearing a command, perform stepping in place with eyes closed. The timing stops if the subject steps on the line or exits the square while stepping with eyes closed. The test should be conducted twice, and the longest time taken should be recorded |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Single-leg stance with eyes closed |
For this test, the subject wears comfortable flat shoes, places hands on hips, and closes their eyes. They then stand on each leg separately, with the other leg bent at the knee and lifted 10cm off the ground, with the lower leg touching the standing leg (although it can be slightly apart during the test). Timing begins when the foot leaves the ground and ends if the standing foot moves, the body leans significantly, or the lifted foot touches the ground. The test is conducted 3 times, with a 1-minute rest in between, and the best result is recorded |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Ankle-Brachial Index (ABI) |
Ankle-Brachial Index (ABI) is a non-invasive vascular test that assesses peripheral arterial disease by comparing blood pressure measurements in the ankles and arms. ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. A normal ABI value is typically between 0.90 and 1.30, with lower values indicating potential arterial blockages. ABI is a crucial diagnostic tool for evaluating peripheral arterial health and identifying risks associated with reduced blood flow to the extremities. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Short-Physical Performance Battery (SPPB) |
The SPPB is the National Institute on Aging's approved method of assessing muscle function in older adults. There are three components, the balance test, the gait speed test, and the chair sit-to-stand test. Asian Working Group for Sarcopenia: 2019 Consensus (AWGS) 2019 recommends SPPB score =9 as the cutoff for low physical performance. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Hospital Anxiety and Depression Scale (HADS) |
The Hospital Anxiety and Depression Scale (HADS) was devised 30 years ago by Zigmond and Snaith to measure anxiety and depression in a general medical population of patients. In this study, it was used to measure the mental condition of participants. The scale comprises 14 questions which related 2 underlying sub-scale dimensions, anxiety (HADS-A) and depression (HADS-D) respectively. Each subscale has 7 items and each item is scored with 0-3 points. The minimum and maximum values of the HADS are 0 and 42. The higher the score, the more severe the condition is. The minimum and maximum values of the subscales are 0 and 21, and higher scores mean a worse outcome. Those with score =8 on HADS-A or HADS-D were considered to be at high risk of having anxiety or depression. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Blood pressure variability (BPV) |
BPV is defined as a change in the value of arterial blood pressure over a defined period of time. Multiple studies have shown that BPV is a strong and independent risk factor for cardiovascular diseases (CVDs), chronic kidney disease, dementia, and stroke, as well as hypertension-related morbidity and mortality. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
HUR Labs Balance Software Suite |
Use the HUR Labs Balance Software Suite static balance testing system to conduct static balance capacity testing. The testing protocol includes Romberg30s, single-leg stance with eyes closed, and Limits of Stability (LOS) testing with a star balance test |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
E/A ratio |
The E/A ratio is an important indicator in echocardiography used to assess blood flow between the left atrium and the left ventricle of the heart. It is calculated using two-dimensional Doppler ultrasound technology by measuring the velocity of blood flow during the early phase of ventricular relaxation (E wave) and during atrial contraction (A wave). The E/A ratio reflects the diastolic function of the heart, particularly the filling pressures and filling rates of the left ventricle. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Star Excursion Balance Test apparatus(SEBT) |
Using a tape measure, mark a "zero" point on the ground and measure out 8 directions at 45° intervals, and assign names to each direction. For the test, the subject should first lie on a yoga mat for the measurement of leg length. Then, the subject should stand in the center, with hands on hips, supporting leg bent at the knee, and the non-supporting leg should be extended as far as possible in 5 directions on the same side. The test should be conducted twice, and the best score should be used. There are two standardized calculation methods: one method calculates the total score as (the sum of the maximum values in the 8 directions) / (8 times the leg length) × 100; the other method calculates the relative distance in each direction as the maximum distance reached / leg length × 100 |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Montreal Cognitive Assessment(MoCA) |
the Montreal Cognitive Assessment(MoCA) was specifically developed as a screening tool for MCI and mild dementia, and has been shown to have high sensitivity and specificity for differentiating individuals with MCI from healthy individuals.A higher score indicates better cognitive function. Firstly, MCI was determined according to the cut point values of different educational levels.Total score =13 (below primary school), =19 (1~6 years of education), =24 (=7 years of education). |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
|
| Secondary |
Brachial-ankle pulse wave velocity (BaPWV) |
Brachial-ankle pulse wave velocity (BaPWV) is a non-invasive measure of arterial stiffness, reflecting the speed of the arterial pressure wave between the brachial artery and ankle arteries. Higher BaPWV values indicate increased arterial stiffness, associated with cardiovascular risks such as hypertension and atherosclerosis. It serves as a valuable tool in clinical settings for assessing vascular health, predicting cardiovascular events, and monitoring the effectiveness of interventions to improve arterial elasticity. |
This study was a cross-sectional study. Each subject was measured only once from the day of randomization to the first assessment, assessed up to 3 months |
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