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SarcopeniaNCT05396404

Empirical Mode Decomposition and Decision Tree in Sarcopenia

An observational study of Sarcopenia and Fall, run by Changhua Christian Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 40 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Fall, Gait, Unsteady
How many people
200 participants
Where
1 siteTaiwan
Study dates
1 Mar 2022to 1 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The subject's data were collected from the e-medical chart system.

Who may be able to join

  • aged from 40 - 90
  • DXA test performed
  • blood sample tests were performed

Who cannot join

  • stroke history
  • amputation
  • cancer related disease

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Changhua Christian Hospital

    Changhua, 500

Other trials in Taiwan

About this study

Official title: Using Empirical Mode Decomposition and Decision Tree to Extract the Balance and Gait Features and Classification in Sarcopenia

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.

Read the detailed 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.

Keywords
empirical mode decomposition, machine learning, decision tree
Medical subject headings
Sarcopenia, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05396404
Study groupRoleWhat they receive
observationall subject data were retrieved from databank which is stored in the e-medical chart system.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. center of pressure (COP)

    Use computerized dynography to measure the postural sway displacement, velocity (etc., mm, mm/sec)

    Measured: baseline: subject was enrolled

  2. walking speed

    6m, patients can walk with foot orthosis and assistive devices

    Measured: baseline: subject was enrolled

  3. grip force

    Use a grip force meter (kg) to test both hands for test 3 times

    Measured: baseline: subject was enrolled

  4. step time

    Use computerized dynography to measure spatial gait parameter: step time (ms)

    Measured: baseline: subject was enrolled

  5. stance time

    Use computerized dynography to measure spatial gait parameter: stance time (ms)

    Measured: baseline: subject was enrolled

  6. swing time

    Use computerized dynography to measure spatial gait parameter: swing time (ms)

    Measured: baseline: subject was enrolled

  7. step / stance length

    Use computerized dynography to measure spatial gait parameter: step / stance distance (mm)

    Measured: baseline: subject was enrolled

  8. muscle thickness

    Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.

    Measured: baseline: subject was enrolled

  9. 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.

    Measured: baseline: subject was enrolled

  10. 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.

    Measured: baseline: subject was enrolled

  11. 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.

    Measured: baseline: subject was enrolled

  12. 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

    Measured: baseline: subject was enrolled

  13. Body composition

    Dual energy x-ray absorptiometry (DEXA) measures bone mineral content (BMC), fat-free mass (FFM).

    Measured: baseline: subject was enrolled

Secondary outcomes (13)

  1. concentration of CRP (C-Reactive Protein)

    The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.

    Measured: baseline: subject was enrolled

  2. 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.

    Measured: baseline: subject was enrolled

  3. 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.

    Measured: baseline: subject was enrolled

  4. concentration of Hemoglobin (Hb)

    The concentration of Hb in the blood test.

    Measured: baseline: subject was enrolled

  5. 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

    Measured: baseline: subject was enrolled

  6. concentration of Cholesterol

    The concentration of Cholesterol in the blood test.

    Measured: baseline: subject was enrolled

  7. concentration of Triglyceride

    The concentration of Triglyceride in the blood test.

    Measured: baseline: subject was enrolled

  8. concentration of Transferrin

    The concentration of Transferrin in the blood test.

    Measured: baseline: subject was enrolled

  9. 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

    Measured: baseline: subject was enrolled

  10. Body Mass Index (BMI)

    (body weight) kg/(height) m*(height)m

    Measured: baseline: subject was enrolled

  11. 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.

    Measured: baseline: subject was enrolled

  12. calf muscle circumference

    Use ruler to measure the bilateral calf muscle circumference, It is an anthropometric parameter commonly used in clinical practice.

    Measured: baseline: subject was enrolled

  13. 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.

    Measured: baseline: subject was enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05396404
Sponsor's protocol ID
CCH IRB 211235
Status last verified
Feb 2022
First submitted
26 May 2022
Last updated
8 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Fall, run by Changhua Christian Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

center of pressure (COP) (time frame: baseline: subject was enrolled). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05396404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

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