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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05396404
Other study ID # CCH IRB 211235
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date July 1, 2024

Study information

Verified date February 2022
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sarcopenia is quickly becoming a major global public health issue. Falls are the leading cause of mortality among the elderly, and they must be addressed. The investigators will use machine learning techniques such as empirical mode decomposition technology and decision tree algorithms to extract the characteristics and classification of sarcopenia in this retrospective study in order to offer clinically proven and effective interventional strategies to prevent, stabilize, and reverse sarcopenia.


Description:

Sarcopenia is becoming a severe global public health concern as the world's elderly population grows. Sarcopenia is characterized by muscular mass and strength loss, as well as impaired physical performance, and it is frequently connected with negative health outcomes such as falls. Falls are a primary cause of death in older individuals and must be addressed. Sarcopenia is currently diagnosed clinically using three primary technologies: imaging technology, precision medicine, and machine learning. In this study, the investigators will use previously collected data from nearly 200 community-dwelling subjects, including medical history, biochemistry, body composition, balance and gait, electromyography, and functional performance, to extract the characteristics and classification of sarcopenia using machine learning techniques such as empirical mode decomposition technology and decision tree algorithms. The investigators intend to offer clinically proven and effective interventional strategies to prevent, stabilize, and reverse sarcopenia.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date July 1, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: - aged from 40 - 90 - DXA test performed - blood sample tests were performed Exclusion Criteria: - stroke history - amputation - cancer related disease

Study Design


Locations

Country Name City State
Taiwan Changhua Christian Hospital Changhua

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary center of pressure (COP) Use computerized dynography to measure the postural sway displacement, velocity (etc., mm, mm/sec) baseline: subject was enrolled
Primary walking speed 6m, patients can walk with foot orthosis and assistive devices baseline: subject was enrolled
Primary grip force Use a grip force meter (kg) to test both hands for test 3 times baseline: subject was enrolled
Primary step time Use computerized dynography to measure spatial gait parameter: step time (ms) baseline: subject was enrolled
Primary stance time Use computerized dynography to measure spatial gait parameter: stance time (ms) baseline: subject was enrolled
Primary swing time Use computerized dynography to measure spatial gait parameter: swing time (ms) baseline: subject was enrolled
Primary step / stance length Use computerized dynography to measure spatial gait parameter: step / stance distance (mm) baseline: subject was enrolled
Primary muscle thickness Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. baseline: subject was enrolled
Primary international Quality of Life Assessment Short Form -36 (SF-36) including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.
The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
baseline: subject was enrolled
Primary amplitude of Muscle activity use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters. baseline: subject was enrolled
Primary Fear of fall scale A 15-item self-report questionnaire for measuring fear of falling. Each item is rated on a Likert-type scale from 1 (strongly disagree) to 4 (strongly agree). The total possible score ranges from 15-60, with higher scores indicating greater fear of falling. baseline: subject was enrolled
Primary Bone density A bone density test, DEXA, measures the mineral content of the bones in certain areas of the skeleton. A DEXA scan is a type of medical imaging test. It uses very low levels of x-rays to measure how dense participants' bones are. DEXA stands for "dual-energy X-ray absorptiometry." The bone density area includes: Hip and Spine baseline: subject was enrolled
Primary Body composition Dual energy x-ray absorptiometry (DEXA) measures bone mineral content (BMC), fat-free mass (FFM). baseline: subject was enrolled
Secondary concentration of CRP (C-Reactive Protein) The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation. baseline: subject was enrolled
Secondary concentration of ALB (Serum albumin) The concentration of ALB in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema. baseline: subject was enrolled
Secondary concentration of Glomerular Filtration Rate (GFR) The concentration of GFR in the blood test. The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease. It can calculate it from the results of the blood creatinine test. baseline: subject was enrolled
Secondary concentration of Hemoglobin (Hb) The concentration of Hb in the blood test. baseline: subject was enrolled
Secondary concentration of Glucose SPOT The concentration of Glucose SPOT in the blood test. TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation baseline: subject was enrolled
Secondary concentration of Cholesterol The concentration of Cholesterol in the blood test. baseline: subject was enrolled
Secondary concentration of Triglyceride The concentration of Triglyceride in the blood test. baseline: subject was enrolled
Secondary concentration of Transferrin The concentration of Transferrin in the blood test. baseline: subject was enrolled
Secondary Berg balance test (BBS) including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
The item scores are summed, minimum score =0, maximum score = 56
baseline: subject was enrolled
Secondary Body Mass Index (BMI) (body weight) kg/(height) m*(height)m baseline: subject was enrolled
Secondary Mini-mental state examination (MMSE) It is an 11-question measure that tests five areas of cognitive function:
orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
baseline: subject was enrolled
Secondary calf muscle circumference Use ruler to measure the bilateral calf muscle circumference, It is an anthropometric parameter commonly used in clinical practice. baseline: subject was enrolled
Secondary Timed up and go To determine fall risk and measure the progress of balance, sit to stand and walking. Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. To document if the assistive device used. Stopwatch to record the whole task duration. baseline: subject was enrolled
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