Strength-based Tailored-Exercise Program at Home for Geriatric Patients

March 31, 2026 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Doris Sau Fung YU, PhD
  • Phone Number: 39176319
  • Email: dyu1@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • Doris Sau Fung YU, PhD
          • Phone Number: 3917 6319
          • Email: dyu1@hku.hk
        • Principal Investigator:
          • Doris Sau Fung YU, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Strength-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.
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.
Other: Physical activity education

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Short Physical Performance Battery (SPPB)
Time Frame: 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.
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Admission and Emergency Department Attendance
Time Frame: 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.
It will be collected at baseline (T0), and 1 year
The 11-item Edmonton Frail Scale（EFS）
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week
Qualitative data collection
Time Frame: 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.
It will be conducted at T2
Appendicular Skeletal Muscle Mass Index (ASMI)
Time Frame: 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
It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEP@Home full trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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