Physical InactivityNCT06326710
The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong
A study testing mHealth and Health Talk in people with Physical Inactivity and Frailty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Frailty
- What is being tested?
- mHealth and Health Talk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2024to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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 for at least 150 minutes per week
- scoring 0 or 5 in the FRAIL scale
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong: a Feasibility Pilot Randomized Controlled Trial Study Protocol
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.
Read more
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.
- Conditions
- Physical Inactivity, Frailty
- Being tested
- mHealth, Health Talk
- Medical subject headings
- Sedentary Behavior, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthBehavioural
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.
Health TalkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Group | Experimental | This arm of participants will be receiving 4 sessions of face-to-face or online delivered mHealth intervention. Receives: 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. Receives: Behavioral: Health Talk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1
Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program
Will be assessed by semi-structured interview guide.
Measured: Month 1
Secondary outcomes (5)
Change in Physical activity level (Objective) at 1 month and 3 months
ActiGraphs will be used to collect objective data on moderate-to-vigorous intensity physical activity. It is validated wrist-worn tri-axial accelerometers capturing motion on three axes: vertical (Y), horizontal right-left (X), and horizontal front-back axis at a sampling frequency of 30hz.
Measured: Baseline, Month 1, Month 3
Change in Physical activity level (Subjective) at 1 month and 3 months
Rapid Assessment of Physical Activity Scale will be used to measure physical activity level. The scale is a 9-item questionnaire that uses a yes-or-no response format. It covers the range of PA levels, from sedentary to regular vigorous PA (RAPA1), as well as strength training and flexibility (RAPA2). A RAPA1 score less than 6 means sub-optimal and is used as a benchmark for not meeting the standard recommendations for physical activity. A RAPA2 score less than 3 is considered as suboptimal, meaning inadequate attainment of anaerobic PA.
Measured: Baseline, Month 1, Month 3
Change in Exercise self-efficacy at 1 month and 3 months
The Chinese version Exercise self-efficacy will be used to examine the degree of an individual's confidence in exercising regularly. It consisted of nine items rated on an 11-point Likert scale, where '0' represents 'not confident' and '10' represents 'very confident'. Answers from the nine questions were averaged to a score ranged from 0 to 10, with higher scores corresponding to higher confidence in performing exercise and higher exercise self-efficacy.
Measured: Baseline, Month 1, Month 3
Change in Mental well-being at 1 month and 3 months
The Chinese version of the seven-item short Warwick-Edinburgh Mental Well-Being Scale will be used to measure mental well-bing. The questions, which covered both hedonic and eudemonic aspects, were rated on a 5-point Likert scale, where '1' indicated 'none of the time' and '5' indicated 'all the time'. A mean score was calculated by averaging the scores of the seven questions. A higher score indicated a higher level of well-being.
Measured: Baseline, Month 1, Month 3
Change in usage of outdoor exercise facilities
A self-developed questionnaire will be used to capture the usage of outdoor exercise facilities. Information on the frequency, duration, and types of outdoor exercise facilities used.
Measured: Baseline, Month 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
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
- NCT06326710
- Sponsor's protocol ID
- P0045122
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40471669
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong: a Feasibility Pilot Randomized Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT06326710
- Acronym / sponsor ID
- P0045122
- Conditions
- Physical Inactivity, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 22 Mar 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Group | Experimental | Behavioral: mHealthThis arm of participants will be receiving 4 sessions of face-to-face or online delivered mHealth intervention. |
| Control Group | Active comparator | Behavioral: Health TalkThis arm of participants will be receiving 4 sessions of face-to-face or online exercise delivered health talks. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| mHealthParticipants 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. | Behavioural | mHealth Group |
| Health TalkParticipants 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. | Behavioural | Control Group |
Primary outcome
Feasibility outcome: Recruitment rate
Time frame: Baseline
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.
Feasibility outcome: Intervention completion rate
Time frame: Month 1
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).
Feasibility outcome: Attrition rate
Time frame: Month 1
Will be assessed by study record. It indicates the rate at which participants dropped out or discontinued their participation in the study.
Feasibility outcome: Attendance
Time frame: Month 1
Will be assessed by study record (e.g., attendance log). It is the percentage of sessions attended over all the offered sessions.
Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App
Time frame: Month 1
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.
Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program
Time frame: Month 1
Will be assessed by semi-structured interview guide.
5 secondary outcomes
Change in Physical activity level (Objective) at 1 month and 3 months
Time frame: Baseline, Month 1, Month 3
Change in Physical activity level (Subjective) at 1 month and 3 months
Time frame: Baseline, Month 1, Month 3
Change in Exercise self-efficacy at 1 month and 3 months
Time frame: Baseline, Month 1, Month 3
Change in Mental well-being at 1 month and 3 months
Time frame: Baseline, Month 1, Month 3
Change in usage of outdoor exercise facilities
Time frame: Baseline, Month 1, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 40471669Lee 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth and Health Talk in people with Physical Inactivity and 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 2 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: finished, as of the sponsor's last update on 3 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome: Recruitment rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326710, which also lists 1 linked publication.
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 3 Oct 2024.