NCT06516367

Brief Summary

There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. In this study, we developed and validated a new tool for the simultaneous screening of muscle wasting diseases in older adults. The diagnostic accuracy of the new tool was compared to other validated screening tools including the Mini Nutritional Assessment-Short Form (MNA-SF), the Short Nutritional Assessment Questionnaire (SNAQ), and the Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

July 3, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

screeningolder adultmalnutritioncachexiasarcopenia

Outcome Measures

Primary Outcomes (2)

  • reliability of a new tool for the simultaneous screening of muscle wasting diseases in older adults

    Relaibility; Cronbach's alpha coefficient was used to evaluate the internal consistency.

    10 months

  • validity of a new tool for the simultaneous screening of muscle wasting diseases in older adults

    Validity; Spearman's correlation coefficient was used to examine construct validity of the new tool

    10 months

Secondary Outcomes (1)

  • The diagnostic accuracy of the new tool

    10 months

Interventions

25 items dichotomous questionnaire

Also known as: bioelectrical impedence analysis, handheld dynamometer

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

300 older participants aged 60 years old and above who were admitted to Ain Shams University Hospitals or interviewed at the hospital clinic

You may qualify if:

  • Participants Aged 65 years and older, who agree to participate

You may not qualify if:

  • Patients with critical illness.
  • Patients with severe cognitive, hearing or visual impairment hindering proper communication
  • Patients with physical disability that interfere with physical performance assessment or hand grip measurement
  • Patient with any contraindication of to the use of BIA) e.g. presence of a pacemaker, other implanted electrical devices, or metal implants, volume overload

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

MalnutritionSarcopeniaCachexia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsWeight LossBody Weight ChangesBody WeightThinness

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Geriatrics and Gerontology

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 23, 2024

Study Start

June 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations