NCT04152070

Brief Summary

The purpose of this cross-sectional study is to validate the Spanish version of the Kihon Checklist for screening frailty in Spanish community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 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

March 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

November 2, 2019

Last Update Submit

November 2, 2019

Conditions

Keywords

FrailtySpanishOlder adults

Outcome Measures

Primary Outcomes (5)

  • Frailty: The Kihon Checklist

    The Kihon Checklist is a self-reporting survey used for screening frail older adults. It consists of 25 yes/no questions divided into 7 domains: activities of daily living, physical strength, nutrition, eating, socialization, memory, and depressive mood. Higher scores indicate a higher risk of requiring support. A total score ≥ 7 points indicates general frailty (Sewo Sampaio 2016). The Spanish Kihon version used for validation in this study was translated by Maseda et al. (2017).

    The cohort group was assessed in one day visit.

  • Frailty: Fried's Frailty Phenotype

    Fried's Frailty Phenotype proposed in the Cardiovascular Health Study (Fried 2001) consists of 5 criteria: unintentional weight loss, exhaustion, low physical activity, reduced grip strength, and reduced gait speed. It has a total score ranging from 0 to 5. A frail person is who scores 3 to 5; prefrail when scores 1 to 2, and robust when scores 0.

    The cohort group was assessed in one day visit.

  • Frailty: The Edmonton Frailty Scale

    The Edmonton Frailty Scale (Rolfson 2006) evaluates 9 domains of frailty: cognition, general health status, functional independence, social support, medication usage, nutrition, mood, continence, and functional performance. It has a total score ranging from 0 to 17, with higher scores representing greater frailty severity.

    The cohort group was assessed in one day visit.

  • Frailty: The Frail Scale

    Frailty measured by the Frail Scale (Masanes et al., 2012). It has a total score of 5 points. The more score the more frailty. Participants are considered frail individuals with scores 3 to 5; prefrail with scores 1 to 2, and robust with scores of 0.

    The cohort group was assessed in one day visit.

  • Frailty: The Tilburg Frailty Indicator

    The Tilburg Frailty Indicator (Gobbens et al., 2010) is a self-reported questionnaire of 15 items addressing physical, psychological and social domains. The total score of the Tilburg scale can range from 0 to 15. Higher scores indicate more frailty.

    The cohort group was assessed in one day visit.

Secondary Outcomes (13)

  • Handgrip strength

    The cohort group was assessed in one day visit.

  • Knee extension strength

    The cohort group was assessed in one day visit.

  • Elbow flexion strength

    The cohort group was assessed in one day visit.

  • Muscle mass

    The cohort group was assessed in one day visit.

  • Gait speed

    The cohort group was assessed in one day visit.

  • +8 more secondary outcomes

Study Arms (1)

Community-dwelling older adults

Community-dwelling older adults living in the Valencia region (Spain).

Other: No intervention

Interventions

There was no intervention to be administered, only collection of data through various tests and questionnaires.

Community-dwelling older adults

Eligibility Criteria

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

Community-dwelling older adults living in the Valencia region.

You may qualify if:

  • Age ≥ 65 years
  • Community-dwelling older adults

You may not qualify if:

  • Barthel Index \< 85 points considering as disabled
  • Mini-Mental State Examination \< 18 points
  • Acute disease
  • Unstable chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46600, Spain

Location

Related Publications (17)

  • Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.

    PMID: 8602410BACKGROUND
  • Bahat G, Tufan A, Kilic C, Karan MA, Cruz-Jentoft AJ. Methodological issues in determination of low muscle mass reference cut-off values: Reply to Comment on "Cut-off points to identify sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) definition". Clin Nutr. 2017 Jun;36(3):903-904. doi: 10.1016/j.clnu.2017.02.023. Epub 2017 Mar 11. No abstract available.

    PMID: 28336166BACKGROUND
  • 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
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND
  • Gobbens RJ, van Assen MA, Luijkx KG, Wijnen-Sponselee MT, Schols JM. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010 Jun;11(5):344-55. doi: 10.1016/j.jamda.2009.11.003. Epub 2010 May 8.

    PMID: 20511102BACKGROUND
  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PMID: 8126356BACKGROUND
  • Herrero J, Gracia E. A [Brief Measure of Depressive Symptomatology (CESD-7)]. Salud Ment 2007;30(5):40-46.

    BACKGROUND
  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

    PMID: 5349366BACKGROUND
  • Lobo A, Saz P, Marcos G, Dia JL, de la Camara C, Ventura T, Morales Asin F, Fernando Pascual L, Montanes JA, Aznar S. [Revalidation and standardization of the cognition mini-exam (first Spanish version of the Mini-Mental Status Examination) in the general geriatric population]. Med Clin (Barc). 1999 Jun 5;112(20):767-74. Spanish.

    PMID: 10422057BACKGROUND
  • 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
  • Maseda A, Lorenzo-Lopez L, Lopez-Lopez R, Arai H, Millan-Calenti JC. Spanish translation of the Kihon Checklist (frailty index). Geriatr Gerontol Int. 2017 Mar;17(3):515-517. doi: 10.1111/ggi.12892. No abstract available.

    PMID: 28345232BACKGROUND
  • Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A, Rockwood K. Validity and reliability of the Edmonton Frail Scale. Age Ageing. 2006 Sep;35(5):526-9. doi: 10.1093/ageing/afl041. Epub 2006 Jun 6. No abstract available.

    PMID: 16757522BACKGROUND
  • Rubenstein LZ, Harker JO, Salva A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric practice: developing the short-form mini-nutritional assessment (MNA-SF). J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M366-72. doi: 10.1093/gerona/56.6.m366.

    PMID: 11382797BACKGROUND
  • Sewo Sampaio PY, Sampaio RA, Yamada M, Arai H. Systematic review of the Kihon Checklist: Is it a reliable assessment of frailty? Geriatr Gerontol Int. 2016 Aug;16(8):893-902. doi: 10.1111/ggi.12833.

    PMID: 27444395BACKGROUND
  • Tomas JM, Galiana L, Fernandez I. The SF-8 Spanish Version for Health-Related Quality of Life Assessment: Psychometric Study with IRT and CFA Models. Span J Psychol. 2018 Mar 22;21:E1. doi: 10.1017/sjp.2018.4.

    PMID: 29562950BACKGROUND
  • Vilaro J, Gimeno E, Sanchez Ferez N, Hernando C, Diaz I, Ferrerc M, Roca J, Alonso J. [Daily living activity in chronic obstructive pulmonary disease: validation of the Spanish version and comparative analysis of 2 questionnaires]. Med Clin (Barc). 2007 Sep 15;129(9):326-32. doi: 10.1157/13109543. Spanish.

    PMID: 17910846BACKGROUND
  • Working Group on Functional Outcome Measures for Clinical Trials. Functional outcomes for clinical trials in frail older persons: time to be moving. J Gerontol A Biol Sci Med Sci. 2008 Feb;63(2):160-4. doi: 10.1093/gerona/63.2.160. No abstract available.

    PMID: 18314451BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Trinidad Sentandreu Mañó, PT, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR
  • Jose M. Tomas, PhD

    University of Valencia

    STUDY CHAIR
  • J. Ricardo Salom Terrádez, PhD

    Doctor Peset University Hospital, Valencia, Spain

    STUDY CHAIR
  • Mercè Balasch i Bernat, PT, PhD

    University of Valencia

    STUDY CHAIR
  • Natalia Cezón Serrano, PT

    University of Valencia

    STUDY CHAIR
  • Maria A Cebrià i Iranzo, PT, PhD

    University of Valencia

    STUDY CHAIR
  • Maria A Tortosa Chuliá, PhD

    University of Valencia

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 5, 2019

Study Start

March 1, 2018

Primary Completion

September 28, 2018

Study Completion

September 28, 2018

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations