Effects of a Multicomponent Training Based on the VIVIFRAIL Program on Functional Performance and Cognitive Function in Acutely Hospitalized Older People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
The goal of this clinical trial is to determine whether a multicomponent physical exercise program improves functional and cognitive capacity in hospitalized older adults compared to the usual hospital care. The main questions it aims to answer are:
- Does a multicomponent physical exercise program improve functional and cognitive capacity?
- Is there a difference between a multicomponent physical exercise program and usual care regarding functional and cognitive outcomes after an acute hospitalization?
Researchers will compare a multicomponent physical exercise program (containing strength, balance, and walking exercises) to the usual care of the hospital to see if the program is better at maintaining or enhancing functional and cognitive outcomes
Participants will:
- Participate in multicomponent physical exercise program or receive usual care. The multicomponent group will complete the program daily for the entire hospitalization period;
- Perform functional and cognitive tests at the beginning and end of hospitalization;
- Be contacted by researchers 3, 6, and 12 months after hospital discharge.
详细描述
Aging is a natural and multifactorial process associated with various physiological and behavioral changes. Some of these changes can lead to increased physical inactivity, resulting in declines in functionality and increased vulnerability to diseases. During acute hospitalization, one of the several clinical consequences is excessive bedrest, even when walking is possible. Which leads to functional decline, defined as iatrogenic nosocomial disability. The literature already well describes that a multicomponent physical exercise program improves functional and cognitive capacity in frail, institutionalized, or hospitalized old people. However, a program based on this model has not yet been implemented during short-term hospitalization in Brazil. Therefore, this study aims to evaluate the effects of a multicomponent program on functional performance and cognitive function in elderly individuals with different conditions of frailty during acute hospitalization at the "Hospital de Clínicas de Porto Alegre". Functional performance will be assessed using the Short Physical Performance Battery, Timed Up and Go, 6-meter gait velocity, handgrip strength, and muscle power in 3-times-sit-to-stand. Cognitive performance will be evaluated through the Mini-Mental State Examination, Geriatric Depression Scale-15, and part "A" of the Trail Making Test. Affectiveness of the intervention will be measured using the Affectivity Scale. Participants will be randomized into two groups: multicomponent training based on VIVIFRAIL (MT) and control group. Participants in both groups will receive usual hospital treatments, including physiotherapy sessions in the morning. Participants in the MT group will perform the exercise program adjusted to their frailty and with progressive volume in the afternoon. On hospital discharge day, patients will be re-evaluated. Statistical analysis will be conducted using Generalized Estimating Equations, adopting group and time factors with two stratifications. Post-hoc LSD tests will be used to identify differences between groups. Analyses will be performed both per protocol, for individuals who complete the study, and by intention-to-treat, including those who do not complete the protocol. Results will be considered significant when p ≤ 0.05 and presented as percentage change and standard deviation with a 95% confidence interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 70 years or older;
- •Capable of ambulating independently or with assistance;
- •Pre-hospitalization Barthel Index ≥ 60;
- •Does not have a terminal illness;
- •Able to participate in the testing procedures and the multicomponent training program, as determined by the physician;
- •Capable of providing informed consent for participation in the study.
排除标准
- •Duration of hospitalization < 3 days;
- •Lack of willingness to complete the phases of the project;
- •Complications related to disease progression or intervention.
研究组 & 干预措施
Multicomponent Training
The subjects will perform multicomponent training sessions every day until hospital discharge day. It is composed of strength, power, balance, and walking exercises. The intervention is based on the VIVIFRAIL program, adapted for the participant's functional level.
干预措施: Multicomponent physical exercise training (Other)
Control
Subjects will receive the usual care of the hospital
结局指标
主要结局
Short Physical Performance Battery
时间窗: Baseline and immediately after the intervention
The Short Physical Performance Battery will assess three components: static balance by having the participant stand for 10 seconds in three different positions (feet together side-by-side, semi-tandem, and tandem); gait by a 4-meter walk; and leg strength by a five-times sit-to-stand test. It ranges from zero (absence of depressive symptoms) to fifteen points (maximum score of depressive symptoms). Performance is quantified by scoring. The score ranges from 0 (functional disability) to 12 points (robust).
Sit-To-Stand Muscle Power
时间窗: Baseline and immediately after the intervention
A linear encoder will assess the muscle power in the sit-to-stand test. The values of the best repetition will be considered.
Timed Up and Go
时间窗: Baseline and immediately after the intervention
The Timed Up and Go test will assess dynamic balance by having the participant stand up from a chair, walk 3 meters, turn around, and return to the chair.
Hand Grip Strength
时间窗: Baseline and immediately after the intervention
Assessed by Hand Grip Test with Hydraulic Dynamometer
Gait Symmetry
时间窗: Baseline and immediately after the intervention
Gait symmetry will be assessed by an inertial sensor. It will be obtained from the autocorrelation function of the acceleration signal along the x-axis. Gait symmetry will be considered the difference between the prominence of the first peak and the second peak after the central peak.
Gait Regularity
时间窗: Baseline and immediately after the intervention
Gait regularity will be assessed by an inertial sensor. It will be measured using the approximate entropy of the acceleration signal.
6-meter walk test
时间窗: Baseline and immediately after the intervention
Participants will be asked to walk a 6-meter course at their usual pace, and the time taken will be recorded.
Gait Variability
时间窗: Baseline and immediately after the intervention
Gait variability will be assessed by an inertial sensor. It will be estimated by calculating the coefficient of variation of the step time.
Mini Exam of Mental State
时间窗: Baseline and immediately after the intervention
It is a screening tool used to assess cognitive function, with scoring based on a 30-point scale, where lower scores indicate greater cognitive impairment. It ranges from zero (cognitive impairment) to thirty points (good cognitive function).
Trial Making Test Part A
时间窗: Baseline and immediately after the intervention
It is an assessment of cognitive functions. In Part A, participants connect numbered circles in sequential order. The time taken to complete the task is recorded, with longer times indicating potential cognitive impairment
Geriatric Depression Scale
时间窗: Baseline and immediately after the intervention
It is a depressive symptoms scale, that consists of 15 questions with binary answers (yes/no) and is easy to understand. It ranges from zero (absence of depressive symptoms) to fifteen points (maximum score of depressive symptoms).
次要结局
- Adherence To Intervention(Immediately after the intervention)
- Affectivity with the intervention(Immediately after the intervention)
- Length of Hospitalization(Immediately after the intervention)
- Hospital Readmission(At 3, 6, and 12 months after the intervention)
- Number of falls(At 3, 6, and 12 months after the intervention)
- Institutionalization post-hospitalization(At 3, 6, and 12 months after the intervention)
- Mortality(At 3, 6, and 12 months after the intervention)
研究者
Eduardo Lusa Cadore
Associate Professor
Federal University of Rio Grande do Sul