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

NCT06191276 | Completed

• 1 other identifier: STEP@Home
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Geriatrics

Keywords

Geriatric patients; hospitalization-associated functional decline (HAFD); Frailty

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (12)

• The Life Space Assessment (LSA-C)

  Baseline

• The Life Space Assessment (LSA-C)

  10th week

• The Life Space Assessment (LSA-C)

  20th week

• The Life Space Assessment (LSA-C)

  28th week

• European Quality of Life 5 Dimensions 5 Level Version (EuroQoL-5D-5L)

  Baseline

Study Arms (2)

STEP@Home Intervention

EXPERIMENTAL

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.

Behavioral: STEP@Home Intervention

Usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

STEP@Home Intervention 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.

STEP@Home Intervention

Usual care 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.

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Doris Sau Fung YU, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)