Frailty, Geriatrics
Conditions
Keywords
Strength-based Tailored-Exercise Program, geriatric care, Hospitalization-associated functional decline, health aging, functional outcome, post-discharge period
Brief summary
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.
Detailed description
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.
Interventions
OTHERStrength-based Tailored-Exercise Program at Home (STEP@Home)
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.
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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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 \[T3\]).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 \>3.5. 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Short Physical Performance Battery (SPPB) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | It measures the level of frailty by positioning an individual on the spectrum of frailty through a multidimensional assessment (Hilmer et al., 2009). It allows a more comprehensive outcome evaluation, especially some of its domains, including cognition, mood, nutritional status, functional independence, and performance, which were responsive to post-discharge exercise training among older adults.18 Its brevity only requires 5-10 minutes for completion, and the EFS has good reliability, stability, and criterion validity in older Chinese adults |
| 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 | It measures physical function in terms of mobility level in everyday activities. It assesses mobility level at five life-space levels in the past 4 weeks: i) living room other than the bedroom, ii) outside the house, iii) the neighborhood (within 800m of home), iv) outside the neighborhood (within 8km) and v) outside the town (beyond 16km). Example locations representing various distances from subjects' homes will be provided to facilitate the responses. The reliability of LSA-C is 0.88, with good criterion and construct validity |
| 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 | It comprises a 5-level response set (5-L), including mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a 0-100 visual analogue scale to measure perceived health. The EuroQoL-5D-5L is more discriminative than the conventional 3L version for, with a Cronbach's alpha of 0.86 |
| Qualitative data collection | It will be conducted at T2 | As for the qualitative data collection, the interviews will be conducted for the 30 subjects recruited through purposive sampling. Broad, open-ended questions will guide the semi-structured interview, which focuses on the perceived effects of STEP@Home on functional and health status, how it works (if any) or not works, challenges of implementation, and concerns of longer-term exercise engagement. The findings will enhance the interpretation of the quantitative outcome-based evaluation. |
| Hospital Admission and Emergency Department Attendance | It will be collected at baseline (T0), and 1 year | Hospital admission and Emergency Department Attendance data including number of attendance, length of stay, and major diagnosis will be collected as health-related outcomes. |
| 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 | Bioelectrical impedance analysis (BIA) measured appendicular skeletal muscle mass index with a higher score indicating higher muscle mass |
Countries
Hong Kong
Contacts
CONTACTDoris Sau Fung YU, PhD
PRINCIPAL_INVESTIGATORDoris Sau Fung YU, PhD
The University of Hong Kong
Outcome results
None listed