Clinical trial NCT05148351: Validity of an App to Detect Frailty and Sarcopenia Syndromes in Elderly
Official title: Validity of an iPhone App to Detect Frailty and Sarcopenia Syndromes in Community Dwelling Older Adults: Protocol for a Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Frailty Syndrome
Aging
Aged
Diagnosis
Keywords: Functional Capacity
Sit-to-Stand Test
Muscle Power
Chair rise
Lead sponsor: Catholic University of Murcia
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 775
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 400 community-dwelling older adults, older than 60 y/o and living in the Region of Murcia (Spain) will be recruited.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscular power
timeFrame: Cross-sectional baseline
measure: Frailty Syndrome
timeFrame: Cross-sectional baseline
measure: Sarcopenia
timeFrame: Cross-sectional baseline
measure: Calf and mid-upper arm circumference
timeFrame: Cross-sectional baseline
Secondary outcomes:
measure: Subjects' clinical status
timeFrame: Cross-sectional baseline
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Juan D Ruiz-Cárdenas
role: STUDY_DIRECTOR
References:
citation: Montemurro A, Ruiz-Cardenas JD, Martinez-Garcia MDM, Rodriguez-Juan JJ. Validity of an iPhone App to Detect Prefrailty and Sarcopenia Syndromes in Community-Dwelling Older Adults: The Protocol for a Diagnostic Accuracy Study. Sensors (Basel). 2022 Aug 11;22(16):6010. doi: 10.3390/s22166010.