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FrailtyNCT06820021

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

A study testing Strength-based Tailored-Exercise Program at Home (STEP@Home) and Physical activity education in people with Frailty and Geriatrics, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Frailty, Geriatrics
What is being tested?
Strength-based Tailored-Exercise Program at Home (STEP@Home) and Physical activity education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
1 siteHong Kong
Study dates
23 May 2025to 1 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Doris Sau Fung YU, PhD contact

39176319

dyu1@hku.hk

Hong Kong1 site, 1 recruiting

  • the University of Hong Kong

    Hong Kong

    Doris Sau Fung YU, PhD, 3917 6319, dyu1@hku.hk

    Doris Sau Fung YU, PhD

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Conditions
Frailty, Geriatrics
Being tested
Strength-based Tailored-Exercise Program at Home (STEP@Home), Physical activity education
Keywords
Strength-based Tailored-Exercise Program, geriatric care, Hospitalization-associated functional decline, health aging, functional outcome, post-discharge period
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength-based Tailored-Exercise Program at Home (STEP@Home)Other

    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.

  • Physical activity educationOther

    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.

Study groups in NCT06820021
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Other: Strength-based Tailored-Exercise Program at Home (STEP@Home)
Control groupOtherThe 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.
Receives: Other: Physical activity education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

Secondary outcomes (6)

  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

    Measured: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

  2. 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

    Measured: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

  3. 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

    Measured: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

  4. 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.

    Measured: It will be conducted at T2

  5. Hospital Admission and Emergency Department Attendance

    Hospital admission and Emergency Department Attendance data including number of attendance, length of stay, and major diagnosis will be collected as health-related outcomes.

    Measured: It will be collected at baseline (T0), and 1 year

  6. Appendicular Skeletal Muscle Mass Index (ASMI)

    Bioelectrical impedance analysis (BIA) measured appendicular skeletal muscle mass index with a higher score indicating higher muscle mass

    Measured: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start23 May 2025
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820021
Sponsor's protocol ID
STEP@Home full trial
Status last verified
Mar 2026
First submitted
27 Jan 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tseng YC, Gau BS, Lou MF. Validation of the Chinese version of the Life-Space Assessment in community-dwelling older adults. Geriatr Nurs. 2020 Jul-Aug;41(4):381-386. doi: 10.1016/j.gerinurse.2019.11.014. Epub 2019 Dec 7.

    PubMed 31818502

  • Sunde S, Hesseberg K, Skelton DA, Ranhoff AH, Pripp AH, Aaronaes M, Brovold T. Effects of a multicomponent high intensity exercise program on physical function and health-related quality of life in older adults with or at risk of mobility disability after discharge from hospital: a randomised controlled trial. BMC Geriatr. 2020 Nov 11;20(1):464. doi: 10.1186/s12877-020-01829-9.

    PubMed 33176703

  • Lee JS, Auyeung TW, Leung J, Kwok T, Woo J. Transitions in frailty states among community-living older adults and their associated factors. J Am Med Dir Assoc. 2014 Apr;15(4):281-6. doi: 10.1016/j.jamda.2013.12.002. Epub 2014 Feb 16.

    PubMed 24534517

  • Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.

    PubMed 31189323

  • Guralnik JM, Winograd CH. Physical performance measures in the assessment of older persons. Aging (Milano). 1994 Oct;6(5):303-5. doi: 10.1007/BF03324256. No abstract available.

    PubMed 7893776

  • Ashworth NL, Chad KE, Harrison EL, Reeder BA, Marshall SC. Home versus center based physical activity programs in older adults. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD004017. doi: 10.1002/14651858.CD004017.pub2.

    PubMed 15674925

  • Zisberg A, Shadmi E, Sinoff G, Gur-Yaish N, Srulovici E, Admi H. Low mobility during hospitalization and functional decline in older adults. J Am Geriatr Soc. 2011 Feb;59(2):266-73. doi: 10.1111/j.1532-5415.2010.03276.x.

    PubMed 21314647

  • Weber M, Belala N, Clemson L, Boulton E, Hawley-Hague H, Becker C, Schwenk M. Feasibility and Effectiveness of Intervention Programmes Integrating Functional Exercise into Daily Life of Older Adults: A Systematic Review. Gerontology. 2018;64(2):172-187. doi: 10.1159/000479965. Epub 2017 Sep 15.

    PubMed 28910814

  • Tavares JPA, Nunes LANV, Gracio JCG. Hospitalized older adult: predictors of functional decline. Rev Lat Am Enfermagem. 2021 Jan 8;29:e3399. doi: 10.1590/1518-8345.3612.3399. eCollection 2021.

    PubMed 33439951

  • McCullagh R, O'Connell E, O'Meara S, Dahly D, O'Reilly E, O'Connor K, Horgan NF, Timmons S. Augmented exercise in hospital improves physical performance and reduces negative post hospitalization events: a randomized controlled trial. BMC Geriatr. 2020 Feb 7;20(1):46. doi: 10.1186/s12877-020-1436-0.

    PubMed 32033532

  • Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.

    PubMed 30419096

  • Loyd C, Markland AD, Zhang Y, Fowler M, Harper S, Wright NC, Carter CS, Buford TW, Smith CH, Kennedy R, Brown CJ. Prevalence of Hospital-Associated Disability in Older Adults: A Meta-analysis. J Am Med Dir Assoc. 2020 Apr;21(4):455-461.e5. doi: 10.1016/j.jamda.2019.09.015. Epub 2019 Nov 14.

    PubMed 31734122

  • Hilmer SN, Perera V, Mitchell S, Murnion BP, Dent J, Bajorek B, Matthews S, Rolfson DB. The assessment of frailty in older people in acute care. Australas J Ageing. 2009 Dec;28(4):182-8. doi: 10.1111/j.1741-6612.2009.00367.x.

    PubMed 19951339

  • Greysen SR, Stijacic Cenzer I, Auerbach AD, Covinsky KE. Functional impairment and hospital readmission in Medicare seniors. JAMA Intern Med. 2015 Apr;175(4):559-65. doi: 10.1001/jamainternmed.2014.7756.

    PubMed 25642907

  • Geyskens L, Jeuris A, Deschodt M, Van Grootven B, Gielen E, Flamaing J. Patient-related risk factors for in-hospital functional decline in older adults: A systematic review and meta-analysis. Age Ageing. 2022 Feb 2;51(2):afac007. doi: 10.1093/ageing/afac007.

    PubMed 35165688

Questions about this trial

What is this clinical trial studying?

A study testing Strength-based Tailored-Exercise Program at Home (STEP@Home) and Physical activity education in people with Frailty and Geriatrics, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Doris Sau Fung YU, PhD (39176319, dyu1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06820021, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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