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Completed

NCT Number: NCT06191276

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alice Ho Miu Ling Nethersole Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • (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).

Treatment and study plan

STEP@Home Intervention

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. The 5-item FRAIL Scale (FS)

    Time frame: Baseline

    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.

  2. The 5-item FRAIL Scale (FS)

    Time frame: 10th week

    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.

  3. The 5-item FRAIL Scale (FS)

    Time frame: 20th week

    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.

  4. The 5-item FRAIL Scale (FS)

    Time frame: 28th week

    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.

  5. The 11-item Edmonton Frail Scale

    Time frame: Baseline

    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.

  6. The 11-item Edmonton Frail Scale

    Time frame: 10th week

    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.

  7. The 11-item Edmonton Frail Scale

    Time frame: 20th week

    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.

  8. The 11-item Edmonton Frail Scale

    Time frame: 28th week

    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.

  9. The Short Physical Performance Battery (SPPB)

    Time frame: Baseline

    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.

  10. The Short Physical Performance Battery (SPPB)

    Time frame: 10th week

    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.

  11. The Short Physical Performance Battery (SPPB)

    Time frame: 20th week

    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.

  12. The Short Physical Performance Battery (SPPB)

    Time frame: 28th week

    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.

Secondary outcomes

  1. The Life Space Assessment (LSA-C)

    Time frame: Baseline

    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.

  2. The Life Space Assessment (LSA-C)

    Time frame: 10th week

    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.

  3. The Life Space Assessment (LSA-C)

    Time frame: 20th week

    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.

  4. The Life Space Assessment (LSA-C)

    Time frame: 28th week

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: 10th week

    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.

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

    Time frame: 20th week

    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.

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

    Time frame: 28th week

    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.

  9. Unplanned hospital readmissions

    Time frame: Baseline

    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.

  10. Unplanned hospital readmissions

    Time frame: 10th week

    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.

  11. Unplanned hospital readmissions

    Time frame: 20th week

    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.

  12. Unplanned hospital readmissions

    Time frame: 28th week

    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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Combating Hospital-related Function Decline Among Prefrail Older Adults: Pilot Testing of a Strength-based Tailored-Exercise Program at Home (STEP@Home)

Acronym: STEP@Home

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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