NCT05396404

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 8, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

May 26, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

empirical mode decompositionmachine learningdecision tree

Outcome Measures

Primary Outcomes (13)

  • center of pressure (COP)

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

    baseline: subject was enrolled

  • walking speed

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

    baseline: subject was enrolled

  • grip force

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

    baseline: subject was enrolled

  • step time

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

    baseline: subject was enrolled

  • stance time

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

    baseline: subject was enrolled

  • swing time

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

    baseline: subject was enrolled

  • step / stance length

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

    baseline: subject was enrolled

  • muscle thickness

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

    baseline: subject was enrolled

  • 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

  • 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

  • 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

  • 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

  • Body composition

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

    baseline: subject was enrolled

Secondary Outcomes (13)

  • concentration of CRP (C-Reactive Protein)

    baseline: subject was enrolled

  • concentration of ALB (Serum albumin)

    baseline: subject was enrolled

  • concentration of Glomerular Filtration Rate (GFR)

    baseline: subject was enrolled

  • concentration of Hemoglobin (Hb)

    baseline: subject was enrolled

  • concentration of Glucose SPOT

    baseline: subject was enrolled

  • +8 more secondary outcomes

Study Arms (1)

observation

all subject data were retrieved from databank which is stored in the e-medical chart system.

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • stroke history
  • amputation
  • cancer related disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

SarcopeniaGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • TASEN WEI, MD

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

May 31, 2022

Study Start

March 1, 2022

Primary Completion

January 31, 2024

Study Completion

July 1, 2024

Last Updated

September 8, 2022

Record last verified: 2022-02

Locations