NCT03832608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

January 31, 2019

Last Update Submit

April 27, 2021

Conditions

Keywords

Older adultSarcopeniaFrailtyFunctionalityMuscle strengthMuscle massWalk speed

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (7)

  • Functionality: Modified Baecke Questionnaire

    The cohort group will be assessed in one day visit.

  • Functionality: Barthel Index

    The cohort group will be assessed in one day visit.

  • Functionality: Lawton and Brody Questionnaire

    The cohort group will be assessed in one day visit.

  • Frailty: Fried Scale

    The cohort group will be assessed in one day visit.

  • Frailty:Frail Scale

    The cohort group will be assessed in one day visit.

  • +2 more secondary outcomes

Study Arms (1)

Older adults and Sarcopenia

Older adults with and without Sarcopenia living in Valencia Province.

Other: No intervention

Interventions

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

Older adults and Sarcopenia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armonea Group

Valencia, 46015, Spain

Location

Related Publications (9)

  • 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.

    PMID: 20392703BACKGROUND
  • 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.

    PMID: 22323356BACKGROUND
  • 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.

    PMID: 27068239BACKGROUND
  • 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.

    PMID: 24461239BACKGROUND
  • 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.

    PMID: 23664768BACKGROUND
  • 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.

    PMID: 28012107BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

SarcopeniaDiseaseFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Maria A Cebrià i Iranzo, PT, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR
  • Mercè Balasch i Bernat, PT, PhD

    University of Valencia

    STUDY CHAIR
  • Anna Arnal Gómez, PT, PhD

    University of Valencia

    STUDY CHAIR
  • Trinidad Sentandreu Mañó, PT, PhD

    University of Valencia

    STUDY CHAIR
  • Maria A Tortosa Chuliá, PhD

    University of Valencia

    STUDY CHAIR
  • Natalia Cezón Serrano, PT

    University of Valencia

    STUDY CHAIR
  • Jose M Tomás, PhD

    University of Valencia

    STUDY CHAIR
  • Silvia Forcano Sanjuán, MD

    Hospital Universitari i Politècnic La Fe (Valencia)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 6, 2019

Study Start

January 8, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations