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

Frailty Clinical Trial

— STEP@Home  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191276
• Other study ID #: STEP@Home
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Doris Sau Fung YU, PhD
• Phone: +852 39176319
• Email: dyu1[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: October 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Frailty
• Geriatrics

Intervention

Behavioral:
• STEP@Home Intervention
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
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.

Locations

Country	Name	City	State
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 5-item FRAIL Scale (FS)	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.	Baseline
Primary	The 5-item FRAIL Scale (FS)	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.	10th week
Primary	The 5-item FRAIL Scale (FS)	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.	20th week
Primary	The 5-item FRAIL Scale (FS)	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.	28th week
Primary	The 11-item Edmonton Frail Scale	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.	Baseline
Primary	The 11-item Edmonton Frail Scale	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.	10th week
Primary	The 11-item Edmonton Frail Scale	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.	20th week
Primary	The 11-item Edmonton Frail Scale	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.	28th week
Primary	The Short Physical Performance Battery (SPPB)	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.	Baseline
Primary	The Short Physical Performance Battery (SPPB)	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.	10th week
Primary	The Short Physical Performance Battery (SPPB)	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.	20th week
Primary	The Short Physical Performance Battery (SPPB)	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.	28th week
Primary	The Life Space Assessment (LSA-C)	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.	Baseline
Primary	The Life Space Assessment (LSA-C)	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.	10th week
Primary	The Life Space Assessment (LSA-C)	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.	20th week
Primary	The Life Space Assessment (LSA-C)	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.	28th week
Primary	European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)	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.	Baseline
Primary	European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)	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.	10th week
Primary	European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)	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.	20th week
Primary	European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)	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.	28th week
Primary	Unplanned hospital readmissions	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.	Baseline
Primary	Unplanned hospital readmissions	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.	10th week
Primary	Unplanned hospital readmissions	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.	20th week
Primary	Unplanned hospital readmissions	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.	28th week