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临床试验/NCT06438718
NCT06438718已完成不适用

Spanish Language Validation, Validity and Reliability Testing of Frail´BESTest in Frail Institutionalized Residents Over 60 Years of Age With Mild Cognitive Impairment

Instituto de Investigación Sanitaria Aragón1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
1
主要终点
Frail'BESTest: assesses static, dynamic balance and mobility

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Frail'BESTest: assesses static, dynamic balance and mobility

时间窗: Baseline (T0) and 7 days (T1) following baseline.

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%).

次要结局

  • 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.)
  • 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 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.)
  • Falls.(6 months (T2) Following baseline Test.)
  • Performance Oriented Mobility Assessment (POMA): is also known as Tinetti test. It assesses balance and mobility.(Baseline (T0) and 7 days (T1) following baseline.)
  • 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.(Baseline (T0) and 7 days (T1) following baseline.)
  • Patient's decease.(1 year (T3) following baseline.)

研究者

发起方
Instituto de Investigación Sanitaria Aragón
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Calvo Carrión

PhD in Health Sciences

Instituto de Investigación Sanitaria Aragón

研究点 (1)

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