AzTrials
AzTrials

FrailtyNCT04152070

Spanish-language Version of the Kihon Checklist

An observational study of Frailty, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty
How many people
251 participants
Where
1 siteSpain
Study dates
1 Mar 2018to 28 Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Community-dwelling older adults living in the Valencia region.

Who may be able to join

  • Age ≥ 65 years
  • Community-dwelling older adults

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Valencia

    Valencia, 46600

Other trials in Spain

About this study

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

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.

Read the detailed 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.

Conditions
Frailty
Being tested
No intervention
Keywords
Frailty, Spanish, Older adults
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

Study groups in NCT04152070
Study groupRoleWhat they receive
Community-dwelling older adultsCommunity-dwelling older adults living in the Valencia region (Spain).
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: The cohort group was assessed in one day visit.

  2. 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.

    Measured: The cohort group was assessed in one day visit.

  3. 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.

    Measured: The cohort group was assessed in one day visit.

  4. 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.

    Measured: The cohort group was assessed in one day visit.

  5. 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.

    Measured: The cohort group was assessed in one day visit.

Secondary outcomes (13)

  1. Handgrip strength

    Muscle strength was measured by the isometric handgrip strength (Cruz-Jentoft et al., 2010).

    Measured: The cohort group was assessed in one day visit.

  2. Knee extension strength

    Muscle strength was measured by the isometric knee extension (Andrews et al., 1996).

    Measured: The cohort group was assessed in one day visit.

  3. Elbow flexion strength

    Muscle strength measured by the isometric elbow flexion (Andrews et al., 1996).

    Measured: The cohort group was assessed in one day visit.

  4. Muscle mass

    Muscle mass estimated by Bioimpedance analysis (BIA) (Bahat et al., 2016).

    Measured: The cohort group was assessed in one day visit.

  5. Gait speed

    Gait speed was recorded using a 4-meter walking test (Working Group on Functional Outcome Measures for Clinical Trials, 2008).

    Measured: The cohort group was assessed in one day visit.

  6. 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.

    Measured: The cohort group will be assessed in one day visit.

  7. 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.

    Measured: The cohort group was assessed in one day visit.

  8. 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).

    Measured: The cohort group was assessed in one day visit.

  9. 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.

    Measured: The cohort group will be assessed in one day visit.

  10. 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.

    Measured: The cohort group was assessed in one day visit.

  11. 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.

    Measured: The cohort group was assessed in one day visit.

  12. 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.

    Measured: The cohort group was assessed in one day visit.

  13. 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.

    Measured: The cohort group was assessed in one day visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start1 Mar 2018
  3. Primary completion28 Sep 2018
  4. Study completion28 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04152070
Sponsor's protocol ID
H1507116319683
Status last verified
Nov 2019
First submitted
2 Nov 2019
Last updated
5 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 8602410

  • 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.

    PubMed 28336166

  • 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.

    PubMed 20392703

  • 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.

    PubMed 11253156

  • 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.

    PubMed 20511102

  • 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.

    PubMed 8126356

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

  • 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.

    PubMed 5349366

  • 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.

    PubMed 10422057

  • 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.

    PubMed 22323356

  • 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.

    PubMed 28345232

  • 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.

    PubMed 16757522

  • 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.

    PubMed 11382797

  • 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.

    PubMed 27444395

  • 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.

    PubMed 29562950

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty: The Kihon Checklist (time frame: The cohort group was assessed in one day visit.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152070, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in