Validity of an App to Detect Frailty and Sarcopenia Syndromes in Elderly

Aging Clinical Trial

Official title:

Validity of an iPhone App to Detect Frailty and Sarcopenia Syndromes in Community Dwelling Older Adults: Protocol for a Diagnostic Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148351
• Other study ID #: Universidad Católica de Murcia
• Status: Completed
• Start date: February 17, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Catholic University of Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Frailty and sarcopenia are two age-related syndromes which can result in adverse health-related events. The combination of both is more predictive of mortality than either condition alone. These conditions can be reversed through an early detection and appropriate interventions. Nevertheless, scientific community highlights the lack of cheap, portable, rapid and easy-to-use tools for detecting frailty and sarcopenia in combination. The aim of this study is to validate an iPhone App to detect frailty and sarcopenia syndromes in community dwelling older adults. This is a protocol study of a retrospective diagnostic test accuracy study which will include at least 400 participants older than 60 years recruited from elderly social centers of Murcia city. Researchers will recollect data of health status, dependency, cognitive status, and functional capacity of the participants. The index test will consist in the measurement of muscle power exerted during a single Sit-to-stand through an App (iPhone), combined with calf and mid-upper arm circumference. The reference standard will be frailty syndrome and sarcopenia assessed according to Fried's phenotype and to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) (2019) recommendations, respectively. Sensitivity, specificity, positive predictive value, negative predictive values, and area under the curve will be reported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 775
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Community-dwelling older adults living in the Region of Murcia

Exclusion Criteria:

• Barthel Index < 90 pts.
• Mini-Cog test < 3 pts.
• Severe cardiovascular problems
• Pacemaker
• Automatic defibrillator

Related Conditions & MeSH terms

• Aged
• Aging
• Diagnosis
• Frailty
• Frailty Syndrome
• Sarcopenia
• Syndrome

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular power	Muscular power generated by participants will be measured using an App (Sit-to-stand App version 1.1) installed on an iPhone (Apple Inc., USA).; During the execution, subjects will sit on a rigid chair with their arms crossed over their chest with the hip, knee and ankle joints at approximately 90 degrees. Subjects will be asked to stand-up as fast as possible. Participants will complete three STS repetitions. No footwear will be allowed during the test.	Cross-sectional baseline
Primary	Frailty Syndrome	Frailty Syndrome will be assessed according to Fried's Phenotype, which focuses on: Handgrip strength; Usual gait speed; Weight loss; Exhaustion; Physical activity levels; Subjects who will result positive to three out of five criteria will be considered as "frail", whereas if they will result positive to only one or two of them they will be considered as "pre-frail". The absence of each criteria will be necessary to define a subject as "robust".	Cross-sectional baseline
Primary	Sarcopenia	Sarcopenia will be assessed according to the recommendation provided by the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) (2019). This guideline focuses on the assessment of: Leg muscle strength; Muscle mass quantity; Physical performance; The presence of low muscle strength levels will be considered as "probable sarcopenia"; the presence of low muscle mass and strength levels will be considered as "confirmed sarcopenia"; finally, the presence of the three criteria will be considered as "severe sarcopenia".	Cross-sectional baseline
Primary	Calf and mid-upper arm circumference	Researchers will measure subjects' calf and mid-upper arm circumference using a tape measure.	Cross-sectional baseline
Secondary	Subjects' clinical status	Subjects' clinical status will be assessed through a list of questions regarding: socioeconomic level; educational level; chronic pathologies; smoking habits; polypharmacy; depression; number of falls; hospitalization; self-perceived health status	Cross-sectional baseline