NCT05267444

Brief Summary

Frailty is a state of being vulnerable and functional disable due to age-related decline of multiple physiological systems, and is often associated with higher risk of falls, institutionalization, hospitalization, disability, dementia, and death. One of the best strategies to combat the burden of frailty is to promote physical activity in the aging population, especially to the older adults who are already in a frail condition

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

February 24, 2022

Last Update Submit

February 27, 2024

Conditions

Keywords

technology deviceoccupational therapyyoung adultfrail older adultsself-care

Outcome Measures

Primary Outcomes (1)

  • The change of physical activity before and after the program

    Physical activities of the older adults will be measured by the Chinese version of the Physical Activity Scale for the Elderly. The PASE-C is a 12-items scale estimating the frequency and intensity of older adults' lifestyle physical activities with three types of physical activities (leisure-time activity: 5 items; household activity: 6 items; work-related activity: 1 item) during the previous 7-day period. The total score is computed by the multiplication on the time spent (recorded as never, seldom: 1-2 days per week, sometimes: 3-4 days per week, and often: 5-7 days per week) or participation (yes/no) on each activity by items weights, and summarize all the items. Higher scores mean higher frequency and intensity of physical activities.

    baseline pre-intervention, 4.5 months when the program is completed

Secondary Outcomes (13)

  • The change of balance before and after the program

    baseline pre-intervention, 4.5 months when the program is completed

  • The change of cognition status before and after the program

    baseline pre-intervention, 4.5 months when the program is completed

  • The change of short-term memory before and after the program

    baseline pre-intervention, 4.5 months when the program is completed

  • The change of loneliness level before and after the program

    baseline pre-intervention, 4.5 months when the program is completed

  • The change of social isolation before and after the program

    baseline pre-intervention, 4.5 months when the program is completed

  • +8 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Individualized motion-based interactive game program

Procedure: Individualized motion-based interactive game program

Control group

NO INTERVENTION

The control group participants will receive usual care, that is, service that provided by community elderly center

Interventions

The participants will receive a 12-session, 4.5 months home visit service that is provided by the young adults, and supervised by an occupational therapist. Young adults will follow the individualized exercise plan with the older adults, facilitate their use of interactive games, provide psychological and technological support to help older adults cope with their fear of using technologies to perform physical activity.

Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 or above
  • having level of frailty from "managing well" to "living with severe frailty" (Clinical Frailty Scale score 3-7) -- HK-MoCA score 23 or less (add one point to people who had less than 6 year formal education and add 2 points to people who had no formal education)

You may not qualify if:

  • currently receiving any kind of rehabilitation service
  • living with another older adult who is participating in the same study.
  • For young adults:
  • aged 17 to 35
  • having educational level of secondary 5 or above
  • \- having a full-time job

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community center

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arkers Wong, Ph.D.

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 4, 2022

Study Start

June 1, 2022

Primary Completion

November 11, 2023

Study Completion

November 11, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations