Comparison of the effects of various functionalities of the integrated digital self-management system on the improvement of motor health among older adults
| ISRCTN | ISRCTN16869025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16869025 |
- Submission date
- 20/05/2025
- Registration date
- 28/05/2025
- Last edited
- 28/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
With aging, individuals commonly experience a decline in motor function due to natural physiological and physical degradation, leading to reduced independence and quality of life during twilight. In this aging era, traditional healthcare professional-based elderly care resources are no longer sufficient for the increasing elderly population.
Recently, advanced technologies such as sensor technology, the Internet of Things, and artificial intelligence have boosted the development of diverse digital healthcare systems, potentially empowering older adults to self-manage their motor health. Although numerous studies have investigated the effects and usability of such digital self-management systems with unique functionality like assessment and sensor-based physical exercises, few systems have integrated diverse self-management functionalities and identified the optimal functionality design of digital self-management systems to improve older adults’ motor health and self-management confidence.
In this context, to improve the effectiveness and efficacy of digital self-management systems on improving older adults’ motor health and quality of life, researchers have developed a series of digital self-management systems with diverse functionalities and conducted a 12-week study.
Who can participate?
Older adults aged 60 years or above with movement ability for daily activities and communication, without serious diseases or dementia.
What does the study involve?
Participants are randomly allocated to eight groups as below:
1. Digital self-management system with education functionality.
2. Digital self-management system with motor assessment functionality.
3. Digital self-management system with physical exercise functionality.
4. Digital self-management system with education and motor assessment functionalities.
5. Digital self-management system with education and physical exercise functionalities.
6. Digital self-management system with motor assessment and physical exercise functionalities.
7. Digital self-management system with education, motor assessment and physical exercise functionalities.
8. Control group: no treatment
All participants will come to the laboratory once a week and wear a pedometer every day to record their walking steps. Participants in the intervention groups will receive 12 sessions, one per week, and around 40 minutes per session. Participants in the control group will receive no treatment.
What are the possible benefits and risks of participating?
All programs are expected to improve older adults’ motor health and support them with better self-management skills, prevent falls and motor impairments. All procedures will follow ethical guidelines to ensure participant safety.
Where is the study run from?
The Hong Kong Polytechnic University
When is the study starting and how long is it expected to run for?
May 2024 to August 2025
Who is funding the study?
The Hong Kong Polytechnic University
Who is the main contact?
1. Prof. Hailiang Wang, hailiang.wang@polyu.edu.hk
2. Ms Qian Mao, vicky.mao@connect.polyu.hk
Contact information
Public, Principal Investigator
11 Yuk Choi Road
Hung Hom
Kowloon
Hong Kong
0
China
| Phone | +852 (0)2766 5471 |
|---|---|
| hailiang.wang@polyu.edu.hk |
Scientific
11 Yuk Choi Road
Hung Hom
Kowloon
Hong Kong
0
China
| Phone | +852 (0)6107 9945 |
|---|---|
| vicky.mao@connect.polyu.hk |
Study information
| Study design | Single-center interventional multi-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual, Laboratory, University/medical school/dental school |
| Study type | Diagnostic, Prevention, Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparison of the effects of various functionalities of the integrated digital self-management system on the improvement of motor health among older adults: a pilot randomized controlled trial |
| Study objectives | 1. The digital self-management system positively improves older adults' motor function and self-management ability. 2. Digital self-management systems with comprehensive functionalities are more effective in improving older adults' motor function and self-management ability compared with those with single functionality. |
| Ethics approval(s) |
Approved 14/05/2024, PolyU Institutional Review Board (Hong Kong, Hong Kong, 0, China; +852 (0)3400 8541; beckymw.kong@polyu.edu.hk), ref: HSEARS20240502001 |
| Health condition(s) or problem(s) studied | Prevention of motor impairments and falls in community-dwelling older adults |
| Intervention | The study is a 12-week single-center interventional multi-arm randomized controlled trial aimed at investigating the effect of digital self-management systems with different functionalities on improving community-dwelling older adults' motor health and self-management ability. All participants' data were collected at baseline with blinded assessors. A computer-based number randomizer (https://www.randomizer.org/) was used for the randomisation of the participants. An independent researcher, not involved in participant recruitment or intervention delivery, was responsible for generating the allocation sequence and sealing it into anonymous envelopes to ensure allocation concealment. The eligible participants were randomly assigned into eight arms as below: 1. Digital self-management system with education functionality 2. Digital self-management system with motor assessment functionality 3. Digital self-management system with physical exercise functionality 4. Digital self-management system with education and motor assessment functionalities 5. Digital self-management system with education and physical exercise functionalities 6. Digital self-management system with motor assessment and physical exercise functionalities 7. Digital self-management system with education, motor assessment and physical exercise functionalities. 8. Control group: no treatment All participants will come to the laboratory once a week and wear a pedometer every day to record their walking steps. Participants in the intervention group will receive 12 sessions, one per week, and around 40 minutes per session. Participants in the control group will receive no treatment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Digital self-management systems |
| Primary outcome measure | Motor function is measured at baseline and 12 weeks using the: 1. Timed-Up-and-Go test (3TUG) 2. 6-Metre Walk Test 3. Five Times Sit to Stand Test (5STS) 4. Short Physical Performance Battery (SPPB) 5. Physical Activity Scale for the Elderly (PASE) 6. Falls Efficacy Scale-International (FES-I) 7. SARC-F Screen for Sarcopenia 8. Integrated Care for Old People (ICOPE) 9. Hand strength (left and right) |
| Secondary outcome measures | Measured at baseline and 12 weeks: 1. Cognitive status measured using the Montreal Cognitive Assessment (MoCA) and the Subjective Cognitive Decline Questionnaire-9 2. Chronic pain measured using the Chronic Pain Grade questionnaire 3. Frail status measured using the FRAIL scale 4. Nutritional screening using the Simplified Nutritional Assessment Questionnaire 5. Quality of life measured using the EuroQol 5-Dimension 5-Level Questionnaire (EQ5D-5L) 6. Self-efficacy measured using the General Self-efficacy Scale (GSE) 7. Perceived usefulness, attitudes and willingness to use, measured using the Technology Acceptance Model |
| Overall study start date | 14/05/2024 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Senior |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Older than 60 years 2. No serious diseases or dementia 3. Have the ability to move by themselves 4. Have the ability to perform daily activities 5. Without communication difficulties |
| Key exclusion criteria | 1. Aged under 60 years 2. Unstable mental conditions 3. Without movement ability 4. With severe hearing problems or others affecting communication |
| Date of first enrolment | 01/04/2025 |
| Date of final enrolment | 03/05/2025 |
Locations
Countries of recruitment
- China
- Hong Kong
Study participating centre
Hung Hom
Kowloon
Hong Kong
0
China
Sponsor information
University/education
11 Yuk Choi Road
Hung Hom
Kowloon
Hong Kong
0
China
| Phone | +852 (0)2766 5471 |
|---|---|
| hailiang.wang@polyu.edu.hk | |
| Website | http://www.polyu.edu.hk/web/en/home/index.html |
"ROR" |
https://ror.org/0030zas98 |
Funders
Funder type
Government
Government organisation / Universities (academic only)
- Alternative name(s)
- The Hong Kong Polytechnic University, 香港理工大学所有, Hong Kong PolyU, Government Trade School, Hong Kong Technical College, Hong Kong Polytechnic, PolyU, HKPU
- Location
- Hong Kong
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journals and international conferences |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available on request from Prof. Hailiang Wang (hailiang.wang@polyu.edu.hk) |
Editorial Notes
20/05/2025: Study's existence confirmed by PolyU Institutional Review Board.
