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

NCT ID: NCT06191276

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-09-30

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.

Conditions

Frailty; Geriatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

STEP@Home Intervention

This arm involves participants undergoing the 20-week STEP@Home multi-component exercise training program. The program is designed to recondition the functional status of older adults in the post-discharge period and develop long-term exercise engagement.

Group Type: EXPERIMENTAL

STEP@Home Intervention

Intervention Type: BEHAVIORAL

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

Participants in this group receive the usual post-discharge care provided in the hospital setting, including general education on medication, disease-related self-care, and regular medical follow-ups.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Yu, Doris Sau Fung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris Sau Fung YU, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

STEP@Home

Identifier Type: -

Identifier Source: org_study_id