The Effects of a Strength-based Tailored-Exercise Program at Home (STEP@Home) on Health Outcomes of Geriatric Patients at Risk of Hospitalization-associated Functional Decline: A Sequential Mixed-method Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- The Short Physical Performance Battery (SPPB)
研究概览
简要总结
This study focuses on the "Strength-based Tailored-Exercise Program at Home (STEP@Home)" aimed at improving health outcomes for geriatric patients at risk of hospitalization-associated functional decline. It is a sequential mixed-method study that combines quantitative and qualitative approaches.
详细描述
This is a sequential mixed-method study, including a multi-site randomized controlled trial to evaluate the effects of the 20-week STEP@Home program and a subsequent descriptive qualitative study to explore the subjects' experience of program engagement. An overview of the timeline is given in Figure 1. Block randomization with block sizes of 4, 8, and 12, using a restricted shuffled approach with a computer-generated random sequence, will randomly allocate the subjects to receive either STEP@Home or physical activity education at a 1:1 ratio.to develop the STEP@Home intervention, integrating a strength-based, tailored exercise regimen for elderly patients post-hospital discharge. It addresses hospitalization-associated functional decline (HAFD) by engaging patients in sustainable self-practice of physical exercises at home. The study employs empowerment strategies, lifestyle-integrated functional exercises, and optimized tele-platform use to maximize therapeutic benefits. By focusing on empowering patients through sustainable self-practice of physical exercises at home, it aims to enhance physical functions and improve health-related quality of life. The study also has significant real-world implications, potentially offering a scalable, effective solution for the broader geriatric population to manage HAFD, thereby reducing healthcare costs and improving overall well-being. The research intends to assess the program's impact on physical functions and health-related quality of life, utilizing a sequential mixed-method approach for a comprehensive evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
One research assistant who is blinded to the subjects' group status will measure the outcome variables at the three post-test endpoints (i.e., weeks 12 [T1]. 20 [T2], and 32 [T3]).
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) aged 60 or above
- •ii) has an acute hospitalization and the length of hospital stay is of ≥ 2 days2,
- •iii) has risk of functional decline in 3 months following hospitalization as measured by the Screening for High-Risk Patients (SHERPA) score of >3.
- •SHERPA is a brief measure to identify the high risk by screening for the risk factors, including old age, poor health perception, IADL dysfunction, mild cognitive impairment and fall in the previous year.
- •iv) discharged home without any referral for exercise-based rehabilitation
- •v) has a Smartphone to access video calls
- •vi) consented to participate.
排除标准
- •i) admitted with a disabling condition leading to significant functional loss such as stroke,)
- •ii) bed-bound or chair bound
- •iii) with conditions contradictory to exercise training (e.g., acute muscular-skeletal problem, acute and unstable cardio-respiratory disease, etc),
- •iv) engaging in moderate or vigorous exercise (>60min/week) in the past 6 months.
研究组 & 干预措施
Intervention group
The 20-week STEP@Home is a multi-component exercise training program designed to recondition the functional status of older adults in the post-discharge period and to develop long-term exercise engagement. The content is developed based on the recommendations from a scope review and the Vivifrail exercise guideline on home-based exercise for older adults , with expert input from the research team including geriatricians in frailty management, exercise physiologist, nursing academicians in aged care research. Three design characteristics, including an empowerment approach (Funnell & Anderson, 2004), lifestyle-integrated functional exercises (Weber et al., 2018), and an optimized tele-platform, are incorporated into the exercise program to enhance such therapeutic benefit.
干预措施: Strength-based Tailored-Exercise Program at Home (STEP@Home) (Other)
Control group
The control group will receive a general education delivered by the RA during the first home visit, including general post-discharge knowledge related to frailty, nutrition, mental health, and sleep hygiene, all information are publicly accessible no explicit information related to exercise or physical activity will be included. Five monthly telephone calls will be made to record the information related to the general health of the client at week 4th , 8th, 12th ,16th, and 20th. The RA will make home visit for data collection at 12th, 20th and 32nd week endpoints.
The RA will also review the post-discharge planning of the client and record information about referral to any social and health care service. The controls will receive a HK$50 supermarket coupon as incentive, and the same will be applied to the intervention group.
干预措施: Physical activity education (Other)
结局指标
主要结局
The Short Physical Performance Battery (SPPB)
时间窗: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week
It measures the physical functioning. It combines a balance test, gait velocity, and chair stand to reflect the functional capacity of older adults . Its score ranges from 0-12 in an ascending trend toward increased functional status. The minimal clinically important difference (MCID) is 1.0 for the risk of disability and mortality .The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults.
次要结局
- The 11-item Edmonton Frail Scale（EFS）(It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week)
- The Life Space Assessment (LSA-C)(It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week)
- EuroQoL-5D-5L will assess HRQoL(It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week)
- Qualitative data collection(It will be conducted at T2)
- Hospital Admission and Emergency Department Attendance(It will be collected at baseline (T0), and 1 year)
- Appendicular Skeletal Muscle Mass Index (ASMI)(It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week)
研究者
Prof. Yu, Doris Sau Fung
Professor
The University of Hong Kong