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

Overview

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 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.

Interventions

• Other Strength-based Tailored-Exercise Program at Home (STEP@Home)
  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 c
• Other Physical activity education
  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

Primary outcome measures

• 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]

Secondary outcome measures (6)

• The 11-item Edmonton Frail Scale（EFS） [Time frame: 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) [Time frame: 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 [Time frame: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week]
• Qualitative data collection [Time frame: It will be conducted at T2]
• Hospital Admission and Emergency Department Attendance [Time frame: It will be collected at baseline (T0), and 1 year]
• Appendicular Skeletal Muscle Mass Index (ASMI) [Time frame: It will be measured at baseline (T0) before randomization and at the 12th (T1), 20th (T2), and 32nd (T3) week]

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 >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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Hong Kong · 1 center

• the University of Hong Kong — Hong Kong

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. PMID 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. PMID 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. PMID 24534517
• Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28910814

Identifiers

NCT: NCT06820021 · STEP@Home full trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗