Clinical trial NCT03832608: Sarcopenia Cut-points and Functionality in Older Adults
Official title: Relationship Between the Sarcopenia Diagnostic Cut-points and Functionality in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Diagnostic
Keywords: Older adult
Sarcopenia
Frailty
Functionality
Muscle strength
Muscle mass
Walk speed
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults (+65 years) living in Valence Province.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: First criteria of sarcopenia diagnostic: hand grip strength
timeFrame: The cohort group will be assessed in one day visit.
measure: First criteria of sarcopenia diagnostic: knew extension strength
timeFrame: The cohort group will be assessed in one day visit.
measure: First criteria of sarcopenia diagnostic: elbow flexion strength
timeFrame: The cohort group will be assessed in one day visit.
measure: Second criteria of sarcopenia diagnostic: muscle mass
timeFrame: The cohort group will be assessed in one day visit.
measure: Third criteria of sarcopenia diagnostic: walk speed
timeFrame: The cohort group will be assessed in one day visit.
Secondary outcomes:
measure: Functionality: Modified Baecke Questionnaire
timeFrame: The cohort group will be assessed in one day visit.
measure: Functionality: Barthel Index
timeFrame: The cohort group will be assessed in one day visit.
measure: Functionality: Lawton and Brody Questionnaire
timeFrame: The cohort group will be assessed in one day visit.
measure: Frailty: Fried Scale
timeFrame: The cohort group will be assessed in one day visit.
measure: Frailty:Frail Scale
timeFrame: The cohort group will be assessed in one day visit.
measure: Frailty: Kihon Check List (KCL)
timeFrame: The cohort group will be assessed in one day visit.
measure: Comorbidity
timeFrame: The cohort group will be assessed in one day visit.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Armonea Group
Study officials:
affiliation: University of Valencia
name: Maria A Cebrià i Iranzo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Mercè Balasch i Bernat, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Anna Arnal Gómez, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Trinidad Sentandreu Mañó, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Maria A Tortosa Chuliá, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Natalia Cezón Serrano, PT
role: STUDY_CHAIR
affiliation: University of Valencia
name: Jose M Tomás, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitari i Politècnic La Fe (Valencia)
name: Silvia Forcano Sanjuán, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.