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

NCT06820021 | Recruiting

• 1 other identifier: STEP@Home full trial
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty; Geriatrics

Keywords

Strength-based Tailored-Exercise Program; geriatric care; Hospitalization-associated functional decline; health aging; functional outcome; post-discharge period

Outcome Measures

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.

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

Secondary Outcomes (6)

• The 11-item Edmonton Frail Scale（EFS）

  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)

  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

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

• Qualitative data collection

  It will be conducted at T2

• Hospital Admission and Emergency Department Attendance

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

OTHER

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

Interventions

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.

Intervention group

Physical activity education OTHER

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.

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

the University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (21)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• de Foubert M, Cummins H, McCullagh R, Brueton V, Naughton C. Systematic review of interventions targeting fundamental care to reduce hospital-associated decline in older patients. J Adv Nurs. 2021 Dec;77(12):4661-4678. doi: 10.1111/jan.14954. Epub 2021 Jul 9.

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• Clegg AP, Barber SE, Young JB, Forster A, Iliffe SJ. Do home-based exercise interventions improve outcomes for frail older people? Findings from a systematic review. Rev Clin Gerontol. 2012 Feb;22(1):68-78. doi: 10.1017/S0959259811000165. Epub 2012 Aug 24.

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MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Doris Sau Fung YU, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Sau Fung YU, PhD

CONTACT

39176319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One research assistant who is blinded to the subjects' group status will measure the outcome variables at the three post-test endpoints (i.e., weeks 12 \[T1\]. 20 \[T2\], and 32 \[T3\]).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 11, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)