Clinical trial NCT06438718: Spanish Linguistic Validation, Validity and Reliability Test of Frail´BESTest in Elderly Institutionalized Frail People
Official title: Spanish Language Validation, Validity and Reliability Testing of Frail´BESTest in Frail Institutionalized Residents Over 60 Years of Age With Mild Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frail Elderly Syndrome
Mild Cognitive Impairment
Keywords: Fragility
Mild Cognitive Impairment
Older adult
Institutionalised
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 230
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Frail'BESTest: assesses static, dynamic balance and mobility
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
Secondary outcomes:
measure: The Short Physical Performance Battery (SPPB): assesses functional performance
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
measure: Timed up and Go test (TUG): assess lower limb function
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
measure: 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.
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
measure: Dual task cost of gait on naming: is the ability executing two tasks (naming and walking) and the effect gait activity on naming task.
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
measure: The Mini Balance Evaluation System (MiniBESTest): assess complementary systems that contribute to balance function using static, dynamic balance test and mobility test
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
measure: Performance Oriented Mobility Assessment (POMA): is also known as Tinetti test. It assesses balance and mobility.
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
measure: Falls.
timeFrame: 6 months (T2) Following baseline Test.
measure: Patient's decease.
timeFrame: 1 year (T3) following baseline.
measure: Dual task cost of counting backwards on Timed up and Go (TUG): assesses the ability of executing two tasks (counting backwards and performing a mobility test) on the mobility task.
timeFrame: Baseline (T0) and 7 days (T1) following baseline.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: María del Pilar Domínguez Oliván, PhD
role: PRINCIPAL_INVESTIGATOR
References: