Clinical trial NCT04152070: Spanish-language Version of the Kihon Checklist
Official title: Validation of the Spanish-language Version of the Kihon Checklist to Assess Frailty in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Keywords: Frailty
Spanish
Older adults
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 251
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling older adults living in the Valencia region.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frailty: The Kihon Checklist
timeFrame: The cohort group was assessed in one day visit.
measure: Frailty: Fried's Frailty Phenotype
timeFrame: The cohort group was assessed in one day visit.
measure: Frailty: The Edmonton Frailty Scale
timeFrame: The cohort group was assessed in one day visit.
measure: Frailty: The Frail Scale
timeFrame: The cohort group was assessed in one day visit.
measure: Frailty: The Tilburg Frailty Indicator
timeFrame: The cohort group was assessed in one day visit.
Secondary outcomes:
measure: Handgrip strength
timeFrame: The cohort group was assessed in one day visit.
measure: Knee extension strength
timeFrame: The cohort group was assessed in one day visit.
measure: Elbow flexion strength
timeFrame: The cohort group was assessed in one day visit.
measure: Muscle mass
timeFrame: The cohort group was assessed in one day visit.
measure: Gait speed
timeFrame: The cohort group was assessed in one day visit.
measure: Modified Baecke Questionnaire
timeFrame: The cohort group will be assessed in one day visit.
measure: The Short Physical Performance Battery
timeFrame: The cohort group was assessed in one day visit.
measure: Barthel Index
timeFrame: The cohort group was assessed in one day visit.
measure: Lawton and Brody Questionnaire
timeFrame: The cohort group will be assessed in one day visit.
measure: Mini-Mental State Examination
timeFrame: The cohort group was assessed in one day visit.
measure: Short Form Health Survey SF-8
timeFrame: The cohort group was assessed in one day visit.
measure: Depressive symptoms CES-D short form (CESD-7)
timeFrame: The cohort group was assessed in one day visit.
measure: Mini Nutritional Assessment-Short Form (MNA-SF)
timeFrame: The cohort group was assessed in one day visit.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Trinidad Sentandreu Mañó, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Jose M. Tomas, PhD
role: STUDY_CHAIR
affiliation: Doctor Peset University Hospital, Valencia, Spain
name: J. Ricardo Salom Terrádez, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Mercè Balasch i Bernat, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Natalia Cezón Serrano, PT
role: STUDY_CHAIR
affiliation: University of Valencia
name: Maria A Cebrià i Iranzo, PT, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Maria A Tortosa Chuliá, PhD
role: STUDY_CHAIR
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