AzTrials
AzTrials

SarcopeniaSARCOFUNCNCT03832608

Sarcopenia Cut-points and Functionality in Older Adults

An observational study of Sarcopenia and Diagnostic, run by University of Valencia 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
Search all trials

Trial summary

This is a cross-sectional study conducted in older adults living in Valencia Province in order to establish the cut-off points of the multicriteria diagnostic of sarcopenia through functionality and frailty variables. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Sarcopenia, Diagnostic
How many people
300 participants
Where
1 siteSpain
Study dates
8 Jan 2019to 31 Mar 2021
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older adults (+65 years) living in Valence Province.

Who may be able to join

  • People aged > 65 years
  • Residents in Valencia Province (Living-Community, Day-Centers and institutionalized)

Who cannot join

  • Lobo Mini-exam cognoscitive < 18 score
  • Any disorder that prevents from performing the assessment tests.
  • Recent hospitalization or who are in a acute process of any illness (less one month).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Armonea Group

    Valencia, 46015

Other trials in Spain

About this study

Official title: Relationship Between the Sarcopenia Diagnostic Cut-points and Functionality in Older Adults

This is a cross-sectional study conducted in older adults living in Valencia Province in order to establish the cut-off points of the multicriteria diagnostic of sarcopenia through functionality and frailty variables.

Read the detailed description

Sarcopenia is a geriatric syndrome that involves a gradual and generalized loss of the mass and strength of the skeletal muscles. Currently, there is an international debate about the criteria and reference values for the sarcopenia diagnosis, and the main scientific societies encourage improving research on this. The biggest problem lies in the assessment of the diagnostic criterion of muscle mass while the criterion of muscular strength seems safer and more robust. Experts point out the need to adjust the muscle mass indexes to the characteristics of the population studied, and the convenience of relating the three diagnostic criteria of sarcopenia (muscle mass and strength, and walking speed) with other variables that report about functionality and frailty in older adults.

The main objective is to establish different cut-off points for the diagnostic criteria of sarcopenia and relate them with other instruments for assessing functionality in older population of Valencia Province.

To this purpose, data will be collected through various tests and questionnaires about: clinical, demographic and anthropometric characteristics; muscle mass; muscle strength; walk speed; physical and cognitive function; nutritional status; self-perception of health; comorbidity and frailty. With this information it will be possible, as primary outcome, to determine a more sensitive, reliable and valid muscle mass index to predict sarcopenia, and, as a secondary outcome, to establish the relationship between the multicriteria diagnostic of sarcopenia with the functional and frailty variables.

Being tested
No intervention
Keywords
Older adult, Sarcopenia, Frailty, Functionality, Muscle strength, Muscle mass, Walk speed
Medical subject headings
Sarcopenia, Disease, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    There is not intervention to be administered, only collection of data through various tests and questionnaires.

Study groups in NCT03832608
Study groupRoleWhat they receive
Older adults and SarcopeniaOlder adults with and without Sarcopenia living in Valencia Province.
Receives: Other: No intervention

What is being measured

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

  1. First criteria of sarcopenia diagnostic: hand grip strength

    Muscle strength measured by the isometric hand grip strength (reference: Age and Aging. 2010;39:412-23).

    Measured: The cohort group will be assessed in one day visit.

  2. First criteria of sarcopenia diagnostic: knew extension strength

    Muscle strength measured by the isometric knew extension (reference: Phys Ther. 1996;76(3):248-59).

    Measured: The cohort group will be assessed in one day visit.

  3. First criteria of sarcopenia diagnostic: elbow flexion strength

    Muscle strength measured by the isometric elbow flexion (reference: Phys Ther. 1996;76(3):248-59).

    Measured: The cohort group will be assessed in one day visit.

  4. Second criteria of sarcopenia diagnostic: muscle mass

    Muscle mass estimated by Bioimpedance analysis (BIA) (reference: J Aging Phys Act. 2015;23(4):597-606).

    Measured: The cohort group will be assessed in one day visit.

  5. Third criteria of sarcopenia diagnostic: walk speed

    Walk speed measured by the Short Physical Performance Balance test (SPPB) (reference: J Gerontol A Biol Sci Med Sc 2000; 55(4):M221-31.

    Measured: The cohort group will be assessed in one day visit.

Secondary outcomes (7)

  1. Functionality: Modified Baecke Questionnaire

    Functionality measured by the Modified Baecke Questionnaire (reference: Med Clin.2007;129:326-32). The Modified Baecke Questionnaire results in a score to classify people as high, moderate, or low in daily physical activity, based on tertiles.

    Work Index = 0 1 +12 + 13 + 14 + 15 + 16 + 17 + I8)/8 Sport Index = 0 9 + 110 + II1 + I12)/4 Leisure Time Index = 0 ' 3 + 114 + 115 + 116 + 117 + 118 + I19V7 Total Index = work index + sports index + leisure time index.

    Measured: The cohort group will be assessed in one day visit.

  2. Functionality: Barthel Index

    Functionality measured by the Barthel Index (reference: Rev Esp Geriatr Gerontol.1993;28:32-40). Range from 0 to 100 score. High score of 100 means total independent.

    Measured: The cohort group will be assessed in one day visit.

  3. Functionality: Lawton and Brody Questionnaire

    Functionality measured by the Lawton and Brody Questionnaire (reference: Gerontologist.1969;9:179-86).Range from 0 to 8 score. High score of 8 means total independent to perform daily activities.

    Measured: The cohort group will be assessed in one day visit.

  4. Frailty: Fried Scale

    Frailty measured by the Fried Scale (reference: J Gerontol A Biol Sci Med Sc. 2001;56(3):M146-56). It is a scale with 5 domains: weight loss, self-reported exhaustion, physical activity, walking speed, and weakness. It has a total score ≥ 5 points. A frail person is who scores 3 to 5; is prefrail when scores is 1 to 2, and robust if scores is 0.

    Measured: The cohort group will be assessed in one day visit.

  5. Frailty:Frail Scale

    Frailty measured by the Frail Scale (reference: J Nutr Health Aging. 2012;16(7):601-8). It has a total score of 5 points. The more score the more frailty. As in Fried scale, participants with scores 3 to 5 is frail person; with scores 1 to 2 is prefrail, and robust if scores is 0.

    Measured: The cohort group will be assessed in one day visit.

  6. Frailty: Kihon Check List (KCL)

    Frailty measured by the Kihon Check List (reference: Geriatr Gerontol Int. 2016;16(6):709-15). The KCL is a simple self-reporting yes/no survey consisting of 25 questions structured into seven domains /dimensions. A total score ≥ 10 points allow to identify a frail person and each domain can identify the specific need.

    Measured: The cohort group will be assessed in one day visit.

  7. Comorbidity

    Comorbidity measured by Abbreviated Charslon Index (reference: J Chron Dis.1987;40:373-83). Range from 0 to 10 score. High score of 10 means high comorbidity; 0 means absence of comorbidity.

    Measured: The cohort group will be assessed in one day visit.

Timeline

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

  1. First posted6 Feb 2019
  2. Study start8 Jan 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03832608
Sponsor's protocol ID
H1542733812827
Other IDs
H1542733812827
Acronym
SARCOFUNC
Status last verified
Apr 2021
First submitted
31 Jan 2019
Last updated
3 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PubMed 20392703

  • Masanes F, Culla A, Navarro-Gonzalez M, Navarro-Lopez M, Sacanella E, Torres B, Lopez-Soto A. Prevalence of sarcopenia in healthy community-dwelling elderly in an urban area of Barcelona (Spain). J Nutr Health Aging. 2012 Feb;16(2):184-7. doi: 10.1007/s12603-011-0108-3.

    PubMed 22323356

  • Salva A, Serra-Rexach JA, Artaza I, Formiga F, Rojano I Luque X, Cuesta F, Lopez-Soto A, Masanes F, Ruiz D, Cruz-Jentoft AJ. [Prevalence of sarcopenia in Spanish nursing homes: Comparison of the results of the ELLI study with other populations]. Rev Esp Geriatr Gerontol. 2016 Sep-Oct;51(5):260-4. doi: 10.1016/j.regg.2016.02.004. Epub 2016 Apr 9. Spanish.

    PubMed 27068239

  • Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.

    PubMed 24461239

  • Lee WJ, Liu LK, Peng LN, Lin MH, Chen LK; ILAS Research Group. Comparisons of sarcopenia defined by IWGS and EWGSOP criteria among older people: results from the I-Lan longitudinal aging study. J Am Med Dir Assoc. 2013 Jul;14(7):528.e1-7. doi: 10.1016/j.jamda.2013.03.019. Epub 2013 May 10.

    PubMed 23664768

  • Ethgen O, Beaudart C, Buckinx F, Bruyere O, Reginster JY. The Future Prevalence of Sarcopenia in Europe: A Claim for Public Health Action. Calcif Tissue Int. 2017 Mar;100(3):229-234. doi: 10.1007/s00223-016-0220-9. Epub 2016 Dec 24.

    PubMed 28012107

  • Cebria I Iranzo MA, Arnal-Gomez A, Tortosa-Chulia MA, Balasch-Bernat M, Forcano S, Sentandreu-Mano T, Tomas JM, Cezon-Serrano N. Functional and Clinical Characteristics for Predicting Sarcopenia in Institutionalised Older Adults: Identifying Tools for Clinical Screening. Int J Environ Res Public Health. 2020 Jun 22;17(12):4483. doi: 10.3390/ijerph17124483.

    PubMed 32580427

  • Arnal-Gomez A, Cebria I Iranzo MA, Tomas JM, Tortosa-Chulia MA, Balasch-Bernat M, Sentandreu-Mano T, Forcano S, Cezon-Serrano N. Using the Updated EWGSOP2 Definition in Diagnosing Sarcopenia in Spanish Older Adults: Clinical Approach. J Clin Med. 2021 Mar 2;10(5):1018. doi: 10.3390/jcm10051018.

    PubMed 33801427

  • Balasch-Bernat M, Sentandreu-Mano T, Tomas JM, Cebria I Iranzo MA, Tortosa-Chulia MA, Arnal-Gomez A, Cezon-Serrano N. Deepening the understanding of the structural validity of the Tilburg Frailty Indicator. Aging Clin Exp Res. 2023 Jun;35(6):1263-1271. doi: 10.1007/s40520-023-02407-w. Epub 2023 Apr 21.

    PubMed 37085651

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Diagnostic, run by University of Valencia 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 2 inclusion and 3 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 3 May 2021. 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?

First criteria of sarcopenia diagnostic: hand grip strength (time frame: The cohort group will be assessed in one day visit.). The study lists 5 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 NCT03832608, which also lists 9 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 3 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in