NCT06199856

Brief Summary

  1. 1.To develop an artificial intelligence assisted diagnostic model for sarcopenia based on ultrasound images;
  2. 2.To develop artificial intelligence classification and regression models for auxiliary diagnosis of sarcopenia, patient strength estimation, and other functions based on ultrasound image data.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Oct 2020Dec 2028

Study Start

First participant enrolled

October 1, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

7.2 years

First QC Date

December 28, 2023

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Death

    Within 2 years after the initial ultrasound examination

  • Diagnosed sarcopenia

    Skeletal muscle mass index (SMI)\<7 (men) /5.7 (women)kg/m2 (measured by BIA) and gait speed\<1m/s or grip strength\<28kg (men)/18kg (women)

    Within 2 years after the initial ultrasound examination

Study Arms (2)

Hospitalized older adults at risk of sarcopenia

Diagnostic Test: ultrasound scan

Community-dwelling older adults at risk of sarcopenia

Diagnostic Test: ultrasound scan

Interventions

ultrasound scanDIAGNOSTIC_TEST

ultrasound scan

Community-dwelling older adults at risk of sarcopeniaHospitalized older adults at risk of sarcopenia

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The older adults with risk of sarcopenia

You may qualify if:

  • \> 50 years of age
  • Patients with suspected sarcopenia, for example, who needed assistance with walking, rising from a chair, or climbing stairs; recently had a history of falls walking; recent unintentional weight loss

You may not qualify if:

  • Amputated arm or leg
  • Severe oedema (oedema higher than knee level)
  • Implantable pacemaker
  • Impaired consciousness, poor general health, or other reasons that would prevent the individual from completing the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinyi Tang

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Xinyi Tang, Dr.

    Department of Medical Ultrasound, West China Hospital, Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

October 1, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations