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Completed

NCT Number: NCT04152070

Spanish-language Version of the Kihon Checklist

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Valencia

Valencia, 46600, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Frailty: The Kihon Checklist

    Time frame: The cohort group was assessed in one day visit.

    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).

  2. Frailty: Fried's Frailty Phenotype

    Time frame: The cohort group was assessed in one day visit.

    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.

  3. Frailty: The Edmonton Frailty Scale

    Time frame: The cohort group was assessed in one day visit.

    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.

  4. Frailty: The Frail Scale

    Time frame: The cohort group was assessed in one day visit.

    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.

  5. Frailty: The Tilburg Frailty Indicator

    Time frame: The cohort group was assessed in one day visit.

    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.

Secondary outcomes

  1. Handgrip strength

    Time frame: The cohort group was assessed in one day visit.

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

  2. Knee extension strength

    Time frame: The cohort group was assessed in one day visit.

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

  3. Elbow flexion strength

    Time frame: The cohort group was assessed in one day visit.

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

  4. Muscle mass

    Time frame: The cohort group was assessed in one day visit.

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

  5. Gait speed

    Time frame: The cohort group was assessed in one day visit.

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

  6. Modified Baecke Questionnaire

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

    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.

  7. The Short Physical Performance Battery

    Time frame: The cohort group was assessed in one day visit.

    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.

  8. Barthel Index

    Time frame: The cohort group was assessed in one day visit.

    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).

  9. Lawton and Brody Questionnaire

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

    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.

  10. Mini-Mental State Examination

    Time frame: The cohort group was assessed in one day visit.

    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.

  11. Short Form Health Survey SF-8

    Time frame: The cohort group was assessed in one day visit.

    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.

  12. Depressive symptoms CES-D short form (CESD-7)

    Time frame: The cohort group was assessed in one day visit.

    Depressive mood was measured by CESD-7 (Herrero y Gracia, 2007). Summary scores range from 0 to 21, and lower scores denote depressive mood.

  13. Mini Nutritional Assessment-Short Form (MNA-SF)

    Time frame: The cohort group was assessed in one day visit.

    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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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