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Completed

NCT Number: NCT05148351

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

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.

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Key information

Conditions

Sarcopenia Aged Aging Atrophy Diagnosis Disease Frailty Frailty Syndrome Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Muscular power

    Time frame: Cross-sectional baseline

    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.

  2. Frailty Syndrome

    Time frame: Cross-sectional baseline

    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".

  3. Sarcopenia

    Time frame: Cross-sectional baseline

    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".

  4. Calf and mid-upper arm circumference

    Time frame: Cross-sectional baseline

    Researchers will measure subjects' calf and mid-upper arm circumference using a tape measure.

Secondary outcomes

  1. Subjects' clinical status

    Time frame: Cross-sectional baseline

    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

Sponsors and collaborators

Lead sponsor

Catholic University of Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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