A Digitally Supported Outdoor Physical Activity Intervention for Mildly Frail Older Adults in Hong Kong

NCT07752615 | Not Yet Recruiting

• 1 other identifier: P0056261
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The aging population in Hong Kong is projected to reach 36.6% by 2046, with roughly 16.6% of older adults estimated to be mildly frail-a condition linked to higher risks of falls, hospitalization, and mortality. While physical activity (PA) is a key modifiable determinant of frailty, a major service gap exists for mildly frail older adults, who lack tailored support, resources, and long-term self-management programs. Although Hong Kong features over 440 public open spaces equipped with senior-friendly outdoor exercise facilities (OEFs), older adults often lack awareness and knowledge on how to utilize them safely for aerobic, strength, and balance training. Furthermore, existing PA interventions often overlook social-ecological perspectives and fail to optimize built environment resources or address digital literacy barriers to sustain long-term behavior change. To bridge these gaps, our team developed and preliminary-tested OUTDOOR-FIT, a complex, theory-driven, socio-ecological mHealth intervention. OUTDOOR-FIT synergizes Hong Kong's built environment (OEFs), social and volunteer support, individual goal-setting, and digital health technology (a contextually tailored mobile Application) to empower mildly frail older adults to self-manage their PA habits. Building upon promising preliminary findings and qualitative feedback from our initial pilot RCT, the intervention has been refined to incorporate neighborhood OEF environmental audits, supervised outdoor experiential practice sessions, and a train-the-trainer volunteer model to support digital literacy and engagement. The main objective of this study is to evaluate the clinical effectiveness and real-world implementation of the refined OUTDOOR-FIT intervention using a hybrid type 1 effectiveness-implementation design. Primary effectiveness outcomes include physical activity levels, exercise self-efficacy, mental well-being, chronic pain, and social loneliness measured immediately post-intervention, as well as at 3-month and 6-month follow-ups. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, secondary implementation outcomes include Reach, Effectiveness, Adoption, Implementation fidelity, and Organizational Maintenance. This study adopts a mixed-methods design embedded within a two-arm cluster randomized controlled trial (cluster RCT) involving community service units. Mildly frail older adults will be cluster-randomized into either (i) the OUTDOOR-FIT intervention group or (ii) a control group. Quantitative analysis will be conducted to evaluate the immediate and sustained effectiveness of the intervention across the primary health outcomes. The qualitative component will consist of semi-structured interviews with older adult participants and community stakeholders to evaluate intervention adoption, implementation barriers, and long-term organizational maintenance.

Conditions

Physical Inactivity Frailty

Outcome Measures

Primary Outcomes (1)

• Physical Activity Level

  Physical activity level will be assessed using the Chinese version of the Community Healthy Activities Model Program for Seniors questionnaire (CHAMPS-C) to evaluate weekly frequency and duration of various physical activities in older adults. The primary metric derived is the total duration (hours per week) spent on physical activities. The score ranges from 0 to 168 hours per week, with higher scores indicating a higher level of physical activity.

  Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)

Secondary Outcomes (7)

• Exercise Self-Efficacy

  Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)

• Mental Well-Being

  Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)

• Pain Severity

  Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)

• Social Loneliness

  Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)

• Organizational Readiness for Adoption

  Baseline

Study Arms (2)

mHealth Group

EXPERIMENTAL

Receive 4 face-to-face session and self usage of the "Outdoor Rehab-Fit" Mobile App

Behavioral: OUTDOOR-FIT

Active Control

ACTIVE COMPARATOR

Receive 4 face-to-face or online exercise knowledge and practical workshops for mildly frail older adults

Behavioral: Active Control

Interventions

OUTDOOR-FIT BEHAVIORAL

Participants in the intervention group will undergo four weekly educational workshops (once per week), with 1 hour duration led by exercise specialists (i.e., certified personal trainer, kinesiologist, degree in exercise or health sciences), and support by volunteers and mobile application (app). Two of these workshops will include two sessions of senior-friendly OEFs visits. The rest of the workshops will cover various topics including introduction of the app, risk management for exercising outdoor, exercise appropriate for frailer older adults, selecting appropriate exercise intensity, using OEFs for aerobic, strength and balance training, postural awareness when using OEFs, management of pain during exercise, and exercise modification principles when using OEFs, home exercise alternatives in bad weather situation. During the four weeks of intervention, participants will be encouraged to use OEFs by themselves with the assistance of the app.

mHealth Group

Active Control BEHAVIORAL

Participants in the active control group will engage in four weekly health education workshops, each lasting for 60 minutes and including exercise experiential sessions. The workshops will be led by exercise specialists (i.e., certified personal trainer, kinesiologist, degree in exercise or health sciences). The workshops focus on the benefits of different exercises for older adults, particularly older adults with mild frailty. Participants have opportunities to experience different modified exercise suitable for frail older adults that could be practiced as home. This comparator was chosen as this kind of workshop is common and traditional way in promoting PA for mildly frail older adults in community settings.

Active Control

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community-dwelling men or women aged 60 years or over
• self-report of mild frailty as determined by a score of ≥ 1 and ≤ 3 on the Chinese version of the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight (FRAIL) scale
• passing the Physical Activity Readiness- Questionnaire (PAR-Q)
• 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 (MVPA) for at least 150 minutes per week
• scoring 0 or 4/5 in the FRAIL scale
• mildly frail older adults without cognitive ability to respond to self-reported questionnaires

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Central Study Contacts

Janet Lok Chun Lee, PhD

CONTACT

27664354; lcjlee@polyu.edu.hk

Cherry Chan, BSc

CONTACT

61811906; tsz-tung-cherry.chan@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: 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: July 28, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): March 3, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)