Clinical trial NCT06820021: Strength-based Tailored-Exercise Program at Home for Geriatric Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Geriatrics
Keywords: Strength-based Tailored-Exercise Program
geriatric care
Hospitalization-associated functional decline
health aging
functional outcome
post-discharge period
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 256
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 usual care 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.

Eligibility criteria: 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 \>4.5. 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.

Primary outcomes:
measure: The Short Physical Performance Battery (SPPB)
timeFrame: will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3)
Secondary outcomes:
measure: The 11-item Edmonton Frail Scale（EFS）
timeFrame: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3)
measure: The Life Space Assessment (LSA-C)
timeFrame: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3)
measure: EuroQoL-5D-5L will assess HRQoL
timeFrame: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3)
measure: qualitative data collection
timeFrame: It will be conducted at T2
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: the University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Doris Sau Fung YU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Cornette P, Swine C, Malhomme B, Gillet JB, Meert P, D'Hoore W. Early evaluation of the risk of functional decline following hospitalization of older patients: development of a predictive tool. Eur J Public Health. 2006 Apr;16(2):203-8. doi: 10.1093/eurpub/cki054. Epub 2005 Aug 2.
citation: 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.
citation: Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x.
citation: Bilbao A, Garcia-Perez L, Arenaza JC, Garcia I, Ariza-Cardiel G, Trujillo-Martin E, Forjaz MJ, Martin-Fernandez J. Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness. Qual Life Res. 2018 Nov;27(11):2897-2908. doi: 10.1007/s11136-018-1929-x. Epub 2018 Jul 5.
citation: Admi H, Shadmi E, Baruch H, Zisberg A. From research to reality: minimizing the effects of hospitalization on older adults. Rambam Maimonides Med J. 2015 Apr 29;6(2):e0017. doi: 10.5041/RMMJ.10201. eCollection 2015 Apr.