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CompletedNCT06191276STEP@HomeUpdated Dec 3, 2025

Combating Hospital-related Function Decline Among Prefrail Older Adults: A Pilot Study

An interventional study of STEP@Home Intervention and Usual care in Frailty and Geriatrics, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2022, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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 the detailed description

The research is a pilot study 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.

02

Conditions studied

  • Frailty
  • Geriatrics

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Keywords

  • Geriatric patients
  • hospitalization-associated functional decline (HAFD)
  • Frailty
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 681 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • i) aged 60 or above, ii) prefrail as defined by a score of 1-2 on the Frail Scale (FS) which measures fatigue, resistance, ambulation, illness and weight loss over the last 4 weeks, iii) discharged home without any community care referral, iv) cognitively capable to receive exercise training as indicated by an Abbreviated Mental Test score of ≥ 6, and v) consented to participate

Exclusion criteria

Exclusion Criteria:

  • (i) engaging in moderate or vigorous exercise (>60min/week) in the past 6 months, and (ii) with conditions contradictory to exercise training (e.g., acute muscular-skeletal problem, acute and unstable cardio-respiratory disease, etc).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    STEP@Home Intervention

    This arm involves participants undergoing the 20-week STEP@Home multi-component exercise training program. The program is designed to recondition the functional status of older adults in the post-discharge period and develop long-term exercise engagement.

    Behavioral: STEP@Home Intervention

  • Active comparator
    Usual care

    Participants in this group receive the usual post-discharge care provided in the hospital setting, including general education on medication, disease-related self-care, and regular medical follow-ups.

    Behavioral: Usual care

Interventions

  • BehavioralSTEP@Home Intervention

    STEP@Home is a multi-component exercise program designed for prefrail older adults that incorporates active strategies to promote long-term engagement. The optimal level of training is 45-60 minutes of exercise three times per week for at least 20 weeks. For prefrailty management, emphasis is placed on balancing and resistance training (around 15-20 min each) to improve muscle strength and gross mobility and prevent falls. Aerobic and flexibility exercises (10 min each) are also included to improve fitness and walking pace. Sixteen training tasks, including but not limited to those recommended by Vivifrail, for each exercise component (namely, resistance, balance, flexibility and aerobic training) will be adopted. A training manual with step-by-step illustrations of each task in pictures and text will be provided to the subjects, together with a set of simple, easy-to-access equipment (water bottle, elastic band and weight-bearing belt) to support task fulfilment.

  • BehavioralUsual care

    Usual Care Activities will be provided by the elderly community center such as dementia or caregiver supporting service. They will be allowed to use the regular service provided such services are not related to physical activity or exercise training.

06

What researchers measure

Primary outcomes

  1. The 5-item FRAIL Scale (FS)

    measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity.

    Time frame: Baseline

  2. The 5-item FRAIL Scale (FS)

    measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity.

    Time frame: 10th week

  3. The 5-item FRAIL Scale (FS)

    measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity.

    Time frame: 20th week

  4. The 5-item FRAIL Scale (FS)

    measuring frailty status based on the five phenotypes including fatigue, resistance, ambulation, illness and recent weight loss. With one point assigned to each phenotype, a total score of 0 indicates 'robust,' 1-2 'prefrail' and 3-5 'frail' with good validity.

    Time frame: 28th week

  5. The 11-item Edmonton Frail Scale

    supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale.

    Time frame: Baseline

  6. The 11-item Edmonton Frail Scale

    supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale.

    Time frame: 10th week

  7. The 11-item Edmonton Frail Scale

    supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale.

    Time frame: 20th week

  8. The 11-item Edmonton Frail Scale

    supplementing the FS by providing more comprehensive coverage to capture frailty severity (e.g., functional independence and performance, general health status, mood) on a continuous scale.

    Time frame: 28th week

  9. The Short Physical Performance Battery (SPPB)

    combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults.

    Time frame: Baseline

  10. The Short Physical Performance Battery (SPPB)

    combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults.

    Time frame: 10th week

  11. The Short Physical Performance Battery (SPPB)

    combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults.

    Time frame: 20th week

  12. The Short Physical Performance Battery (SPPB)

    combing a balance test, gait velocity and chair stand to reflect the functional capacity of older adults.21 Its score range is 0-12 in an ascending trend toward increased functional status.The SPPB has good predictive validity against functional decline, rehospitalization and mortality in older adults.

    Time frame: 28th week

Secondary outcomes

  1. The Life Space Assessment (LSA-C)

    capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: 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 LSA-C has reliability of 0.88, with good criterion and construct validity.

    Time frame: Baseline

  2. The Life Space Assessment (LSA-C)

    capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: 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 LSA-C has reliability of 0.88, with good criterion and construct validity.

    Time frame: 10th week

  3. The Life Space Assessment (LSA-C)

    capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: 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 LSA-C has reliability of 0.88, with good criterion and construct validity.

    Time frame: 20th week

  4. The Life Space Assessment (LSA-C)

    capturing mobility level of relatively independent prefrail older adults in everyday activities. It assesses the level of mobility at five life-space levels in the past 4 weeks: 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 LSA-C has reliability of 0.88, with good criterion and construct validity.

    Time frame: 28th week

  5. European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)

    assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. 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.

    Time frame: Baseline

  6. European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)

    assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. 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.

    Time frame: 10th week

  7. European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)

    assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. 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.

    Time frame: 20th week

  8. European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)

    assessing Health-Related Quality of Life and generating the utility score for Cost-Effectiveness Analysis. 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.

    Time frame: 28th week

  9. Unplanned hospital readmissions

    will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals.

    Time frame: Baseline

  10. Unplanned hospital readmissions

    will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals.

    Time frame: 10th week

  11. Unplanned hospital readmissions

    will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals.

    Time frame: 20th week

  12. Unplanned hospital readmissions

    will be monitored for a period of 32 weeks via the Hospital Authority Clinical Management System. Information on the date of admission, total length of stay and index diagnosis of admission will be retrieved. The research nurse will also ask the subjects about admissions to private hospitals.

    Time frame: 28th week

07

Study locations

1 site
  • Alice Ho Miu Ling Nethersole Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No — Only study investigators and research assistants involved in the study will have access to the data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06191276
Lead sponsor
The University of Hong Kong
Responsible party
Prof. Yu, Doris Sau Fung (Professor, The University of Hong Kong) — Principal investigator
First posted
Jan 5, 2024
Start date
Dec 1, 2022
Primary completion
Sep 30, 2023
Completion
Sep 30, 2024
Last update
Dec 3, 2025

Study contacts

Doris Sau Fung YU, PhD
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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