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

NCT06438718 | Completed

• 1 other identifier: Validation Frail´BESTest
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Frail Elderly Syndrome

Keywords

Fragility; Mild Cognitive Impairment; Older adult; Institutionalised

Outcome Measures

Primary Outcomes (1)

• Frail'BESTest: assesses static, dynamic balance and mobility

  6 balance systems are tested, with between 2-6 tests per balance system. The balance systems tested are: A: anticipations, B: reactions, C: locomotion, D: sensorial orientation, E: biomechanical constraints and F: gait symmetry. All tests or criteria are scored dichotomously, with 0 for negative results and 1 for positive results. The highest and best possible score for the Frail'BESTest is 26 and the lowest is 0. A. Proactive motor control anticipatory maximum score is 5 and the minimum score is 0 (equivalent to 19%). B. Reactive motor control - reactions - maximum score 2 and minimum score 0 (equivalent to 8%). C. Locomotion and gait - maximum score 6 and minimum score 0 (equivalent to 23%) D. Static postural control maximum score 3 and minimum score 0 (equivalent to 12%). E. Biomechanical restrictions maximum score is 6 and the minimum score is 0 (equivalent to 23%). F. Gait symmetry maximum score is 4 and the minimum score is 0 (equivalent to 15%).

  Baseline (T0) and 7 days (T1) following baseline.

Secondary Outcomes (9)

• The Short Physical Performance Battery (SPPB): assesses functional performance

  Baseline (T0) and 7 days (T1) following baseline.

• Timed up and Go test (TUG): assess lower limb function

  Baseline (T0) and 7 days (T1) following baseline.

• Dual task cost of naming on gait speed: assesses the ability of executing two tasks (naming and walking) in this case the effect of cognitive task on gait speed.

  Baseline (T0) and 7 days (T1) following baseline.

• Dual task cost of gait on naming: is the ability executing two tasks (naming and walking) and the effect gait activity on naming task.

  Baseline (T0) and 7 days (T1) following baseline.

• The Mini Balance Evaluation System (MiniBESTest): assess complementary systems that contribute to balance function using static, dynamic balance test and mobility test

  Baseline (T0) and 7 days (T1) following baseline.

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Group A: Community Living, Non-Frail individuals Cognition preserved (n=30). * Group B: Institutionalized Frail with mild cognitive impairment n=240 (divided in two groups, n= 30 and n=210). * Group C: Institutionalized Frail without cognitive impairment (n=40). * Group B: will be obtained from the users of the residences for the elderly of the Fundación Rey Ardid in Zaragoza: Residencia Rosales and Residencia Juslibol. The recruitment will screen by the physiotherapist working in both residences by a verbal invitation. . * Group C: will be obtained from the users of Casa Amparo (Zaragoza) and the residences of the Federico Ozanam Foundation: Perpetuo Socorro (Garrapinillos), CAI-Ozanam Oliver, San Antonio de Padua, Ibercaja Ozanam La Magdalena, Ozanam Santa Isabel and María Auxiliadora (María de Huerva), Hermanitas de los pobres desamparados and the Mazaruba residence in Zaragoza. The authorised health personnel from each of the centres will screen participants and invite them.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• María del Pilar Domínguez Oliván, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Health Sciences

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: April 1, 2024
• Primary Completion: September 22, 2025
• Study Completion: November 28, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

ES (1)