Spanish-language Version of the Kihon Checklist

Frailty Clinical Trial

Official title:

Validation of the Spanish-language Version of the Kihon Checklist to Assess Frailty in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152070
• Other study ID #: H1507116319683
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: November 2019
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In order to identify individuals at risk for frailty, a wide variety of assessment tools have been developed in recent years. Nevertheless, there is still a lack of a gold standard method to be used. Therefore, simple, reliable, and valid instruments are still needed for both research and clinical purposes. The Kihon Checklist is a multidimensional tool widely used in Japan and in other countries, but an exhaustive validity in Spanish population has not been yet established.

The main objective is to validate the Spanish version of the Kihon Checklist for screening frailty in Spanish community-dwelling older adults, and as a secondary objective, to study and to compare different scales of frailty in the Spanish population, and to study their associations.

To cope with the objectives of the present study, a cross-sectional study was conducted. To this purpose, data were collected through various tests and questionnaires about: frailty; clinical, demographic and anthropometric characteristics; physical assessment; functional status; cognitive function; health-related quality of life; depressive mood; and nutritional status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age = 65 years

• Community-dwelling older adults

Exclusion Criteria:

• Barthel Index < 85 points considering as disabled

• Mini-Mental State Examination < 18 points

• Acute disease

• Unstable chronic disease

Related Conditions & MeSH terms

• Frailty

Intervention

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

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View Citation

Lobo A, Saz P, Marcos G, Día JL, de la Cámara C, Ventura T, Morales Asín F, Fernando Pascual L, Montañés 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. Erratum in: Med Clin (Barc) 1999 Jul 10;113(5):197. — 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

Maseda A, Lorenzo-López L, López-López R, Arai H, Millán-Calenti JC. Spanish translation of the Kihon Checklist (frailty index). Geriatr Gerontol Int. 2017 Mar;17(3):515-517. doi: 10.1111/ggi.12892. — View Citation

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. Epub 2006 Jun 6. — View Citation

Rubenstein LZ, Harker JO, Salvà 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. — View Citation

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. Review. — View Citation

Tomás JM, Galiana L, Fernández 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. — View Citation

Vilaró J, Gimeno E, Sánchez Férez N, Hernando C, Díaz 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. Spanish. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Handgrip strength	Muscle strength was measured by the isometric handgrip strength (Cruz-Jentoft et al., 2010).	The cohort group was assessed in one day visit.
Secondary	Knee extension strength	Muscle strength was measured by the isometric knee extension (Andrews et al., 1996).	The cohort group was assessed in one day visit.
Secondary	Elbow flexion strength	Muscle strength measured by the isometric elbow flexion (Andrews et al., 1996).	The cohort group was assessed in one day visit.
Secondary	Muscle mass	Muscle mass estimated by Bioimpedance analysis (BIA) (Bahat et al., 2016).	The cohort group was assessed in one day visit.
Secondary	Gait speed	Gait speed was recorded using a 4-meter walking test (Working Group on Functional Outcome Measures for Clinical Trials, 2008).	The cohort group was assessed in one day visit.
Secondary	Modified Baecke Questionnaire	Physical condition was measured by the Modified Baecke Questionnaire (Vilaró et al., 2007). The Modified Baecke Questionnaire results in a score to classify people as high, moderate, or low in daily physical activity, based on tertiles.	The cohort group will be assessed in one day visit.
Secondary	The Short Physical Performance Battery	Physical performance was measured by the Short Physical Performance Battery (Guralnik, 1994). This measurement consists of walking 4m, a balance test with 3 levels (tandem, semi-tandem and stand up on one foot) and sit up and reach 5 times as fast as possible. Summary scores range from 0-12, and higher scores denote higher physical performance.	The cohort group was assessed in one day visit.
Secondary	Barthel Index	Functional independence was measured by the Barthel Index. It has a total score ranging from 0 to 100, where 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).	The cohort group was assessed in one day visit.
Secondary	Lawton and Brody Questionnaire	Functional independence was measured by the Lawton and Brody Questionnaire (Lawton and Brody, 1969). Instrumental activities of daily living assess the ability to use the telephone, to shop, to use transport, to cook, to do housework, to take medication, and to handle finances. It has a total score ranging from 0 to 8, 0 indicates total dependence and the maximum score indicates total independence.	The cohort group will be assessed in one day visit.
Secondary	Mini-Mental State Examination	Cognitive function was measured by the Spanish version of the Mini-Mental State Examination (Lobo et al., 1999). Summary scores range from 0 to 35, and higher scores denote higher cognitive function.	The cohort group was assessed in one day visit.
Secondary	Short Form Health Survey SF-8	Health-related quality of life was measured by SF-8 (Tomás et al., 2017). Summary scores range from 8 to 40, and higher scores denote a higher health-related quality of life.	The cohort group was assessed in one day visit.
Secondary	Depressive symptoms CES-D short form (CESD-7)	Depressive mood was measured by CESD-7 (Herrero y Gracia, 2007). Summary scores range from 0 to 21, and lower scores denote depressive mood.	The cohort group was assessed in one day visit.
Secondary	Mini Nutritional Assessment-Short Form (MNA-SF)	Nutritional status was measured by MNA-SF (Rubenstein et al., 2001). Summary scores range from 0 to 14, and higher scores denote better nutritional status.	The cohort group was assessed in one day visit.