Sarcopenia Cut-points and Functionality in Older Adults

Sarcopenia Clinical Trial

— SARCOFUNC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832608
• Other study ID #: H1542733812827
• Secondary ID: H1542733812827
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diagnostic
• Sarcopenia

Intervention

Other:
• No intervention
There is not intervention to be administered, only collection of data through various tests and questionnaires.

Locations

Country	Name	City	State
Spain	Armonea Group	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Arnal-Gómez A, Cebrià I Iranzo MA, Tomas JM, Tortosa-Chuliá MA, Balasch-Bernat M, Sentandreu-Mañó T, Forcano S, Cezón-Serrano N. Using the Updated EWGSOP2 Definition in Diagnosing Sarcopenia in Spanish Older Adults: Clinical Approach. J Clin Med. 2021 Mar — View Citation

Cebrià I Iranzo MA, Arnal-Gómez A, Tortosa-Chuliá MA, Balasch-Bernat M, Forcano S, Sentandreu-Mañó T, Tomas JM, Cezón-Serrano N. Functional and Clinical Characteristics for Predicting Sarcopenia in Institutionalised Older Adults: Identifying Tools for Cli — View 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. — View Citation

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková 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. — View Citation

Ethgen O, Beaudart C, Buckinx F, Bruyère 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. — View 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. — View 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. — View Citation

Salvà A, Serra-Rexach JA, Artaza I, Formiga F, Rojano I Luque X, Cuesta F, López-Soto A, Masanés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The cohort group will be assessed in one day visit.
Primary	First criteria of sarcopenia diagnostic: knew extension strength	Muscle strength measured by the isometric knew extension (reference: Phys Ther. 1996;76(3):248-59).	The cohort group will be assessed in one day visit.
Primary	First criteria of sarcopenia diagnostic: elbow flexion strength	Muscle strength measured by the isometric elbow flexion (reference: Phys Ther. 1996;76(3):248-59).	The cohort group will be assessed in one day visit.
Primary	Second criteria of sarcopenia diagnostic: muscle mass	Muscle mass estimated by Bioimpedance analysis (BIA) (reference: J Aging Phys Act. 2015;23(4):597-606).	The cohort group will be assessed in one day visit.
Primary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.
Secondary	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.	The cohort group will be assessed in one day visit.