Clinical trial NCT06191276: Combating Hospital-related Function Decline Among Prefrail Older Adults: A Pilot Study
Official title: Combating Hospital-related Function Decline Among Prefrail Older Adults: Pilot Testing of a Strength-based Tailored-Exercise Program at Home (STEP@Home)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Geriatrics
Keywords: Geriatric patients
hospitalization-associated functional decline (HAFD)
Frailty
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The 5-item FRAIL Scale (FS)
timeFrame: Baseline
measure: The 5-item FRAIL Scale (FS)
timeFrame: 10th week
measure: The 5-item FRAIL Scale (FS)
timeFrame: 20th week
measure: The 5-item FRAIL Scale (FS)
timeFrame: 28th week
measure: The 11-item Edmonton Frail Scale
timeFrame: Baseline
measure: The 11-item Edmonton Frail Scale
timeFrame: 10th week
measure: The 11-item Edmonton Frail Scale
timeFrame: 20th week
measure: The 11-item Edmonton Frail Scale
timeFrame: 28th week
measure: The Short Physical Performance Battery (SPPB)
timeFrame: Baseline
measure: The Short Physical Performance Battery (SPPB)
timeFrame: 10th week
measure: The Short Physical Performance Battery (SPPB)
timeFrame: 20th week
measure: The Short Physical Performance Battery (SPPB)
timeFrame: 28th week
measure: The Life Space Assessment (LSA-C)
timeFrame: Baseline
measure: The Life Space Assessment (LSA-C)
timeFrame: 10th week
measure: The Life Space Assessment (LSA-C)
timeFrame: 20th week
measure: The Life Space Assessment (LSA-C)
timeFrame: 28th week
measure: European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)
timeFrame: Baseline
measure: European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)
timeFrame: 10th week
measure: European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)
timeFrame: 20th week
measure: European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)
timeFrame: 28th week
measure: Unplanned hospital readmissions
timeFrame: Baseline
measure: Unplanned hospital readmissions
timeFrame: 10th week
measure: Unplanned hospital readmissions
timeFrame: 20th week
measure: Unplanned hospital readmissions
timeFrame: 28th week
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
Study officials:
affiliation: The University of Hong Kong
name: Doris Sau Fung YU, PhD
role: PRINCIPAL_INVESTIGATOR
References: