NCT06326710

Brief Summary

In recent years, research teams around the world have developed interventions to educate older adults to use outdoor exercise facilities (OEFs) to improve health outcomes like strength, balance, mobility, PA level, and weight. These interventions employed trainers or therapists to instruct, and monitor exercise training for older adults using the public accessible OEFs. Apart from therapist or trainer-led intervention, an Australian research team developed a mobile application, and social support strategies to help participants to use OEFs to enhance their aerobic and resistance-based PA. A recent local in-depth qualitative study discovered that OEFs in Hong Kong attracted frailer older adults (i.e., those who recovered from a major illness or who has chronic diseases), and their caregivers to use OEFs to support and maintain their daily PA behavior. Some used OEFs to complement their formal rehabilitation sessions. It appears that OEFs in Hong Kong serves as an important health maintenance space for frailer older adults in the city to "age in place", yet educational training related to OEFs has been lacking over the years. Signage besides the exercise equipment has been the only education material for users over the years. A mobile app-based physical activity education intervention will be developed for frail old adults in Hong Kong. The intervention has two components: (1) mobile app; and (2) face-to-face group session that teaches the how to use correctly and safely use OEF in public parks to maintain PA habits. The main objective of this study is to evaluate the feasibility, acceptability, and pilot effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention. Primary outcomes include recruitment rate, retention rate, attrition rate, attendance, perceived usefulness of the app. Secondary outcomes include exercise self-efficacy, mental well-being, physical activity level. This study adopts a mixed-method design with quantitative and qualitative method. This study is a pilot randomized controlled trial, running for 4 months evaluating of the effectiveness of the mHealth intervention. 40 frail older adults will be randomized into (i) mHealth group or (ii) control group. Quantitative analysis will be adopted to investigate the effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention on the health outcomes of frail older adults. The qualitative component will consist of semi-structure interviews with the frail older adults to understand the acceptability of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
Last Updated

October 3, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

March 11, 2024

Last Update Submit

October 1, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Feasibility outcome: Recruitment rate

    Will be assessed by study record e.g., attendance log in recruitment seminar. It is calculated based on the percentage of who signed up for the study and the total number of approached participants.

    Baseline

  • Feasibility outcome: Intervention completion rate

    Will be assessed by a self-invented record form. It is calculated based on the percentage of completion of all intervention components (Including workshop attendance, app usage and outdoor practice).

    Month 1

  • Feasibility outcome: Attrition rate

    Will be assessed by study record. It indicates the rate at which participants dropped out or discontinued their participation in the study.

    Month 1

  • Feasibility outcome: Attendance

    Will be assessed by study record (e.g., attendance log). It is the percentage of sessions attended over all the offered sessions.

    Month 1

  • Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App

    Will be assessed by self-invented questionnaire. It measures participant's perceptions of the app's usefulness. The questionnaire consists of 3 domains.Overall score ranges from 20 to 100. Higher score indicates higher perceived usefulness.

    Month 1

  • Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program

    Will be assessed by semi-structured interview guide.

    Month 1

Secondary Outcomes (5)

  • Change in Physical activity level (Objective) at 1 month and 3 months

    Baseline, Month 1, Month 3

  • Change in Physical activity level (Subjective) at 1 month and 3 months

    Baseline, Month 1, Month 3

  • Change in Exercise self-efficacy at 1 month and 3 months

    Baseline, Month 1, Month 3

  • Change in Mental well-being at 1 month and 3 months

    Baseline, Month 1, Month 3

  • Change in usage of outdoor exercise facilities

    Baseline, Month 1, Month 3

Study Arms (2)

mHealth Group

EXPERIMENTAL

This arm of participants will be receiving 4 sessions of face-to-face or online delivered mHealth intervention.

Behavioral: mHealth

Control Group

ACTIVE COMPARATOR

This arm of participants will be receiving 4 sessions of face-to-face or online exercise delivered health talks.

Behavioral: Health Talk

Interventions

mHealthBEHAVIORAL

Participants receive 4 sessions of face-to-face or online delivered workshop on how to use the mobile app "Outdoor Rehab-Fit" to support their daily PA level. In addition to the workshop, participants have to go to public parks to practice what they have learnt from the mobile app.

mHealth Group
Health TalkBEHAVIORAL

Participants receive 4 sessions of face-to-face or online delivered health talks on the benefits different types of modified exercises for frail older adults (chair yoga, seated eight-section brocades, Otago and seated multi-component exercise). Each talk has an experiential session.

Control Group

Eligibility Criteria

Age55 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • community-dwelling men or women aged 55 years or over
  • meeting at least one items of the FRAIL scale
  • passing the Physical Activity Readiness- Questionnaire
  • owning a smart phone for daily use
  • signing the informed consent documents

You may not qualify if:

  • older adult participants who achieved adequate level of daily physical activity, as defined as engaging in moderate-to-vigorous intensity physical activity for at least 150 minutes per week
  • scoring 0 or 5 in the FRAIL scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lee JLC, Wong AYL, Ng PHF, Fu SN, Fong KNK, Cheng ASK, Lee KNK, Sun R, Zhang HY, Xiao R. Outdoor Exercise Facility-Based Integrative Mobile Health Intervention to Support Physical Activity, Mental Well-Being, and Exercise Self-Efficacy Among Older Adults With Prefrailty and Frailty in Hong Kong: Pilot Feasibility Randomized Controlled Trial Study. JMIR Mhealth Uhealth. 2025 Jun 5;13:e69259. doi: 10.2196/69259.

MeSH Terms

Conditions

Sedentary BehaviorFrailty

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 22, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 2, 2024

Last Updated

October 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations