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SarcopeniaNCT05148351

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

An observational study of Sarcopenia and Frailty Syndrome, run by Catholic University of Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Frailty Syndrome, Aging
How many people
775 participants
Where
1 siteSpain
Study dates
17 Feb 2022to 1 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Catholic University of Murcia

    Murcia, 30107

Other trials in Spain

About this study

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

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.

Keywords
Functional Capacity, Sit-to-Stand Test, Muscle Power, Chair rise
Medical subject headings
Sarcopenia, Frailty, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Cross-sectional baseline

  2. Frailty Syndrome

    Frailty Syndrome will be assessed according to Fried's Phenotype, which focuses on:

    1. Handgrip strength
    2. Usual gait speed
    3. Weight loss
    4. Exhaustion
    5. 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".

    Measured: Cross-sectional baseline

  3. 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:

    1. Leg muscle strength
    2. Muscle mass quantity
    3. 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".

    Measured: Cross-sectional baseline

  4. Calf and mid-upper arm circumference

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

    Measured: Cross-sectional baseline

Secondary outcomes (1)

  1. 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

    Measured: Cross-sectional baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start17 Feb 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
775 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148351
Sponsor's protocol ID
Universidad Católica de Murcia
Status last verified
Oct 2022
First submitted
25 Nov 2021
Last updated
24 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruiz-Cardenas JD, Rodriguez-Juan JJ, Martinez-Garcia MDM, Montemurro A. Comparing Sarcopenia Definitions and Muscle Power Reduction: Associations with Health Outcomes in Spanish Community-Dwelling Older Adults. J Clin Med. 2024 Aug 23;13(17):4988. doi: 10.3390/jcm13174988.

    PubMed 39274199

  • Ruiz-Cardenas JD, Montemurro A, Martinez-Garcia MDM, Rodriguez-Juan JJ. Sit-to-Stand Video Analysis-Based App for Diagnosing Sarcopenia and Its Relationship With Health-Related Risk Factors and Frailty in Community-Dwelling Older Adults: Diagnostic Accuracy Study. J Med Internet Res. 2023 Dec 8;25:e47873. doi: 10.2196/47873.

    PubMed 38064268

  • 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.

    PubMed 36015771

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Frailty Syndrome, run by Catholic University of Murcia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscular power (time frame: Cross-sectional baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05148351, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.

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