Physical Inactivity FrailtyNCT07752615
A Digitally Supported Outdoor Physical Activity Intervention for Mildly Frail Older Adults in Hong Kong
A study testing OUTDOOR-FIT in people with Physical Inactivity Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity Frailty
- What is being tested?
- OUTDOOR-FIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2027to 3 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Hong Kong
anet Lok Chun Lee, PhD, 27664354, lcjlee@polyu.edu.hk
About this study
Official title: A Digitally Supported Outdoor Physical Activity Intervention for Mildly Frail Older Adults: a Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Controlled Trial (OUTDOOR-FIT)
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.
Read more
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
- Being tested
- OUTDOOR-FIT, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OUTDOOR-FITBehavioural
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.
Active ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Group | Experimental | Receive 4 face-to-face session and self usage of the "Outdoor Rehab-Fit" Mobile App Receives: Behavioral: OUTDOOR-FIT |
| Active Control | Active comparator | Receive 4 face-to-face or online exercise knowledge and practical workshops for mildly frail older adults Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Chinese version of the Exercise Self-Efficacy Scale(SEE-C) was used to assess participants' confidence in maintaining regular exercise. This scale comprises 9 items, each rated on an 11-point Likert scale from 0 (not confident) to 10 (very confident). The mean score of these items, ranging from 0 to 10, represents the overall exercise self-efficacy, with higher scores indicating greater confidence in regularly engaging in exercise.
Measured: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Mental Well-Being
The mental well-being of participants was assessed using the Chinese version of the 7-item Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). This scale addresses both hedonic and eudaimonic aspects of well-being, with items rated on a 5-point Likert scale from 1 (none of the time) to 5 (all the time). The mean score, calculated by averaging responses across the 7 items, reflects the overall mental well-being, with higher scores indicating greater well-being.
Measured: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Pain Severity
Assessed using the Chinese version of the Brief Pain Inventory (BPI-C). The scale evaluates pain severity (4 items, score range 0 to 10) and pain interference with daily functioning (7 items, score range 0 to 10). Items are rated on an 11-point scale from 0 ("no pain" / "does not interfere") to 10 ("pain as bad as you can imagine" / "completely interferes"). Scores are calculated as the mean score for each subscale, with subscale scores ranging from 0 to 10. Higher scores represent greater pain severity or interference (a worse outcome).
Measured: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Social Loneliness
Assessed using the Chinese version of the 6-item De Jong Gierveld Loneliness Scale (DJGLS) to evaluate overall, emotional, and social loneliness. The total score ranges from 0 to 6, with higher scores corresponding to higher levels of perceived loneliness (worse outcome).
Measured: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Organizational Readiness for Adoption
Assessed quantitatively using the Readiness for Implementation Model (RIM) survey administered to community staff and volunteers prior to intervention delivery. The RIM is a multidimensional model comprising 42 elements that evaluate organizational readiness across domains such as leadership support, resource availability, and staff preparedness. Element ratings are combined and converted to an overall readiness index ranging from 0 to 100. Higher scores indicate greater organizational readiness for program adoption and stronger implementation potential (better outcome).
Measured: Baseline
Implementation Fidelity
Assessed using a 15-item standardized fidelity checklist developed based on the program's workflow to evaluate the consistency of protocol delivery across participating community units. The checklist monitors the successful execution of 9 workshop topics (e.g., app introduction, risk management, pain management), 3 organizational components (e.g., volunteer group formation, group chat creation), and 3 practical workshop activities (e.g., outdoor facility visits). The final fidelity rate is calculated as the average percentage of items successfully implemented within the units, ranging from 0% to 100%. A higher percentage indicates greater consistency and stricter adherence to the intervention protocol (better outcome).
Measured: Baseline, immediately post-intervention (Month 1)
Organizational Intention to Maintain
Assessed at the organizational level using a single-item question administered to center management and involved staff to evaluate their commitment to sustain the program in the setting after the study ends. The intention to maintain the program is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree / Extremely Unlikely) to 5 (Strongly Agree / Extremely Likely). Higher scores indicate a stronger organizational intention, commitment, and perceived likelihood to sustain and integrate the intervention into the community partners' routine services (better outcome).
Measured: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion3 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Inactivity FrailtyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE Lok Chun Janet, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752615
- Sponsor's protocol ID
- P0056261
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digitally Supported Outdoor Physical Activity Intervention for Mildly Frail Older Adults: a Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Controlled Trial (OUTDOOR-FIT)
- ClinicalTrials.gov ID
- NCT07752615
- Acronym / sponsor ID
- P0056261
- Conditions
- Physical Inactivity Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 3 Mar 2029 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Group | Experimental | Behavioral: OUTDOOR-FITReceive 4 face-to-face session and self usage of the "Outdoor Rehab-Fit" Mobile App |
| Active Control | Active comparator | Behavioral: Active ControlReceive 4 face-to-face or online exercise knowledge and practical workshops for mildly frail older adults |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OUTDOOR-FITParticipants 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. | Behavioural | mHealth Group |
| Active ControlParticipants 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. | Behavioural | Active Control |
Primary outcome
Physical Activity Level
Time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
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.
7 secondary outcomes
Exercise Self-Efficacy
Time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Mental Well-Being
Time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Pain Severity
Time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Social Loneliness
Time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Organizational Readiness for Adoption
Time frame: Baseline
Implementation Fidelity
Time frame: Baseline, immediately post-intervention (Month 1)
Organizational Intention to Maintain
Time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OUTDOOR-FIT in people with Physical Inactivity Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Lok Chun Lee, PhD (27664354, lcjlee@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.