Spanish Linguistic Validation, Validity and Reliability Test of Frail´BESTest in Elderly Institutionalized Frail People

NCT ID: NCT06438718

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-11-28

Brief Summary

The aging of the global population presents significant social and health challenges. In Aragón, 15% of the population is between 65 and 79 years old, and the over-aging index is 16.6%, higher than the national average. This aging necessitates promoting healthy aging and maintaining functional capacity in advanced ages. Currently, 15% of the Aragonese population is potentially dependent, a figure that rises to 26% among those over 85 years old. The decline in functional capacity is due to auditory, visual, joint, and proprioceptive issues, resulting in increased vulnerability to falls, which are a significant cause of death among the elderly.

The frailty syndrome, although common with aging, is not inevitable and is characterized by the loss of functional capacity and increased risk of falls and hospitalization. To assess this capacity in frail individuals, specific tools like the Mini-Motor Test, the Morton Mobility Index, and the Elderly Mobility Scale exist. The BESTest, developed in 2009, evaluates balance but is time-consuming to administer, leading to the creation of a shorter version, the Mini BESTest. However, both can be limiting for frail individuals.

To address these limitations, the Frail'BESTest was developed, evaluating six balance subsystems and being suitable for frail individuals, making it a valid and sensitive tool in clinical practice. This research project aims to develop tools that identify balance problems in frail individuals with mild cognitive impairment, allowing for specific interventions to reduce the risk of falls.

Detailed Description

This is a cross-sectional study consisting of two phases. In the first phase, the linguistic-transcultural validation of the Frail'BESTest will be carried out in a population (which we will call group A), which will be made up of people over 65 years of age who live in a community, who do not present cognitive impairment and whose physical functional state is preserved.

In a second phase of the study, the validity and reliability of the test will be analysed in frail institutionalised people with mild cognitive impairment. For this purpose, frail people with mild cognitive impairment (group B) and frail people with no cognitive impairment (group C), all of them over 65 years of age, will be selected.

Conditions

Frail Elderly Syndrome; Mild Cognitive Impairment

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Validation group

This Cross-sectional study consists of five phases. PHASE 1 [T1] Consist on the linguistic validation and it will be carried out the transcultural adaptation of Frail'BESTest in a population sample (named group A), which will be made up of 30 individuals over 60 years of age, community living independently in their houses, cognition preserved, who have a preserved physical functional status, and able to stand up still, without assistive devices for 10s or over (Group A).

PHASE 2 [T2] consist on reliability. One subgroup (GROUP B and GROUP C) of institutionalized frail aged participants, n=30 with mild cognitive impairment (named group B) and 30 without mild cognitive impairment (named group C) will be tested. We will examine between raters reliability and test-retest reliability.

PHASE 3 [T3] consisting on construct validity. PHASE 4 [T4] consisting on predictive falls/concurrent validity. PHASE 5 [T4] consisting on predictive decease/concurrent validity.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participants should be able to maintain 10seconds stand feet apart without assistance The Validity of FRAILBESTest in mild cognitive impairment institutionalized patients will be made of subgroup categories: Frail/Non-frail; Cognition preserved/Mild cognitive impairment patients and Institutionalized patients/community living individuals.
• Frailty will be determine by Fried phenotype Those scoring 3 or more out of 5 will be classify as frail and those scoring 2 or less as non-frail individuals. Mini-Mental State Examination (MMSE) cognition status could be preserved or altered (Score >24-30).
• Community living individuals will be non-frail and cognition should preserved they will be assign to Group A.
• Frail institutionalized individual's (scoring from 24 to 26 at MMSE) will be assign to Group B Frail institutionalized individual's (scoring = or > to 27 at MMSE) will be assign to Group C Non frail Institutionalized individuals with cognition preserved (scoring = or > to 27 at MMSE) will be assign to group D.

Exclusion Criteria

• Orthopedic unstable conditions
• Moderate or severe cognitive status Score <24 at MMSE
• Inability to understand indications or communicate with testers.
• Sustaining severe cardiac, vascular or respiratory diseases or conditions that contraindicate physical activity
• Presenting a condition for which, in the opinion of the researchers, the evaluation may pose a risk to their health
• Not having autonomy to decide about their voluntary participation in the study

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role: lead

Responsible Party

Sandra Calvo Carrión

PhD in Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María del Pilar Domínguez Oliván, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

Universidad de Zaragoza

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

Validation Frail´BESTest

Identifier Type: -

Identifier Source: org_study_id