Strength-based Tailored-Exercise Program at Home for Geriatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Strength-based Tailored-Exercise Program at Home (STEP@Home)
Other interventionThe 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.
Physical activity education
Other interventionThe 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.
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
The Short Physical Performance Battery (SPPB)
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.
Time frame
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) weekSecondary outcomes
1
The 11-item Edmonton Frail Scale（EFS）
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
Time frame
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week2
The Life Space Assessment (LSA-C)
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
Time frame
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week3
EuroQoL-5D-5L will assess HRQoL
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
Time frame
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week4
Qualitative data collection
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.
Time frame
It will be conducted at T2Sponsors and contacts
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Source ClinicalTrials.gov