A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 308
- 主要终点
- Frailty Status (pre-test)
研究概览
简要总结
Frailty is a common clinical syndrome that is becoming increasingly important as populations age worldwide. Individuals who are frail are at a higher risk for negative outcomes, such as falls, disability, hospitalizations, and even death. The understanding of frailty has evolved from a straightforward concept to a complex model that includes physical, psychological, cognitive, and social factors. Since frailty is not static and can change over time, early interventions can be beneficial. Nevertheless, research in this area has been challenging due to a lack of agreement on what frailty encompasses and an inadequate understanding of how its different components interact. Defining frailty as a multidimensional issue is essential to recognize the adverse effects that can arise from medical, psychological, and social influences. However, recent studies have not sufficiently addressed how these different aspects work together or developed effective multidimensional interventions.
详细描述
The study will be designed as a four-arm, double-blinded, cluster-randomised controlled trial. A sample (N = 308) of prefrail older adults aged 60-80 years will be recruited from 32 randomly selected elderly community centres in Hong Kong and classified into four frailty deficit patterns (multi-frailty, physical-to-psycho/social, nonphysical-to-psycho/social, and a robust control). With the hypothesised biopsychosocial framework pinpointing the intertwined relationships of these three domains of frailty, four intervention strategies (biological/psychosocial/nutritional, biological/nutritional, psychosocial/nutritional, and an inactive control) will be proposed to improve their overall frailty, regarding their physical, psychological, and social functioning, nutritional status, and lifestyle changes in a 9-month intervention and follow-up period. The primary objective will be to assess the effectiveness of the intervention strategies for improving the frailty status of participants in each of the four frailty deficit pattern groups, and to determine the most effective intervention strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 to 80
- •Willing and capable to participate in this study and training
- •Willing and capable to give informed consent to participate in this study
- •Preliminarily classified as physically prefrail/robust, in that they possess no more than three of the indicators on the Fried Frailty Index (FFI; unintentional weight loss, exhaustion, low physical activity, slow walking speed, weak grip strength; Bieniek et al., 2016)
- •Can walk independently to an elderly centre
- •Have a smartphone for internal group communication and remote interaction with their peers and the instructor
排除标准
- •History of systematic cardiovascular diseases causing stroke, Parkinson's disease, early stages of Alzheimer's disease, or cognitive impairment
- •Physical injuries or other conditions that would hinder regular attendance and participation in the assessments for the study
- •Concurrent major psychiatric disorder (e.g. major depressive disorder, schizophrenia) or drug and alcohol abuse
- •Unable to handle digital devices
- •Currently undergoing exercise programmes or classified as physically 'very active' (i.e. performing strenuous activity for 5+ hours each week)
结局指标
主要结局
Frailty Status (pre-test)
时间窗: Pre-test (1st test): before intervention
The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.
Frailty Status (2nd test)
时间窗: 2nd test: after 3-month intervention
The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.
Frailty Status (3rd test)
时间窗: 3rd test: after 6-month follow up
The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.
Physical Functioning-- Anthropometic Data (pre-test)
时间窗: Pre-test (1st test): before intervention
Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Anthropometric Data (2nd test)
时间窗: 2nd test: after 3-month intervention
Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Anthropometric Data (3rd test)
时间窗: 3rd test: after 6-month follow up
Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Health Related Information (pre-test)
时间窗: Pre-test (1st test): before intervention
Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Health Related Information (2nd test)
时间窗: 2nd test: after 3-month intervention
Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Health Related Information (3rd test)
时间窗: 3rd test: after 6-month follow up
Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Senior Physical Fitness Test Battery (pre-test)
时间窗: Pre-test (1st test): before intervention
The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).
Physical Functioning-- Senior Physical Fitness Test Battery (2nd test)
时间窗: 2nd test: after 3-month intervention
The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).
Physical Functioning-- Senior Physical Fitness Test Battery (3rd test)
时间窗: 3rd test: after 6-month follow up
The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).
Psychological Functioning (pre-test)
时间窗: Pre-test (1st test): before intervention
A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.
Psychological Functioning (2nd test)
时间窗: 2nd test: after 3-month intervention
A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.
Psychological Functioning (3rd test)
时间窗: 3rd test: after 6-month follow up
A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.
Social Function (pre-test)
时间窗: Pre-test (1st test): before intervention
The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Social Function (2nd test)
时间窗: 2nd test: after 3-month intervention
The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Social Function (3rd test)
时间窗: 3rd test: after 6-month follow up
The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
次要结局
- Physical Activity Behavioural Changes (pre-test)(Pre-test (1st test): before intervention)
- Physical Activity Behavioural Changes (2nd test)(2nd test: after 3-month intervention)
- Physical Activity Behavioural Changes (3rd test)(3rd test: after 6-month follow up)
- Exercise Self-efficacy (pre-test)(Pre-test (1st test): before intervention)
- Exercise Self-efficacy (2nd test)(2nd test: after 3-month intervention)
- Exercise Self-efficacy (3rd test)(3rd test: after 6-month follow up)
- Nutrition Self-efficacy (pre-test)(Pre-test (1st test): before intervention)
- Nutrition Self-efficacy (2nd test)(2nd test: after 3-month intervention)
- Nutrition Self-efficacy (3rd test)(3rd test: after 6-month follow up)
- Nutritional Status (pre-test)(Pre-test (1st test): before intervention)
- Nutritional Status (2nd test)(2nd test: after 3-month intervention)
- Nutritional Status (3rd test)(3rd test: after 6-month follow up)
研究者
JIAO Jiao
Research Assistant Professor
Hong Kong Baptist University