- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887648
Effect of Singapore-contextualized Dance-based Exergame Among Community-dwelling Older Adults
Effect of Singapore-contextualized Dance-based Exergame (SinDance) in Promoting Physical Function and Reducing Depressive Symptoms and Falls Among Community-dwelling Older Adults: A Randomised Controlled Trial
The aims of the research are to develop an age-appropriate and culturally sensitive older person-centered, Singapore-contextualized Dance-based Exergame (SinDance), and to pilot test its effectiveness in improving physical function and activity daily living (ADL) and reducing depressive symptoms and falls among community-dwelling older people. It is hypothesized that participants in the SinDance will have: (1) improved postural balance, muscle strength, and ADL; and (2) reduced depressive symptoms, fear of falling, and number of falls, compared to those in the control group.
The research will be structured as a two-phase study.
- In Phase one, development of the SinDance system will be undertaken.
In Phase two, a pilot randomized control trial will be conducted to evaluate the feasibility and potential effectiveness of the newly developed SinDance exergame on the proposed outcomes.
- Eligible participants will be recruited from Lions Befrienders (LB) senior activity centre and randomly assigned to the SinDance group or the control group.
- Participants in the intervention group will receive one face-to-face briefing session and will be required to participate in the newly developed SinDance exergame 3 times a week for 6 weeks, while those in the control group will attend usual activities provided by the centers.
- Outcomes will be measured at baseline, immediate after intervention, and 3 months from baseline.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SinDance will be structured as a two-phase study involving a multi-disciplinary team of software engineers, occupational therapist (OT), and research nurse (RN).
Phase 1: Development of the SinDance system will be undertaken by software engineers in collaboration with an OT and RN.
- The SinDance intervention is a 6-week program consisting of one face-to-face briefing session provided by the Research Nurse (RN)/Research Assistant (RA) and SinDance exergaming. The dance movements will be choreographed for older adults based on local context and culture. The game design of SinDance will be developed on cross-platform game engine called Unity. Body movements will be captured via an external RGB camera. Using an open pose algorithm, the system will be able to track correct body movements based on image processing and body posture recognition, as well as provide active feedback on performance. This allows for real-time movement adjustments by the user to achieve higher compliance rating. Points will be awarded for each correct movement accomplished.
- The SinDance intervention is designed as a leisure game to supplement the daily physical activities of older adults. There will NOT be strenuous or intense physical activities or any vigorous high-velocity movements in this intervention.
Considering that SinDance is a self-regulated exercise, to ensure safety during self-regulated exercise, dance choreography will be designed with varying levels of movement difficulty, speed and rhythm tempo to cater to the different needs of individual participants. The SinDance game interface will be designed with minimal action buttons to enhance usability and user- experience for older people to operate.
Phase 2: Pilot test to assess the effectiveness of SinDance exergame Study Design - A pilot two-arm randomized control trial with repeated measures will be conducted in Phase 2. Eligible participants will be recruited from Lions Befrienders (LB) senior activity centre. They will be randomly allocated to either intervention group or control group using block randomisation technique. The data will be collected at baseline, immediately after the intervention (i.e., 6 weeks from baseline) and 3 months from baseline.
Study Intervention
- The exergame will run on a laptop, the display of game will be either on an external monitor or project to screen via a projector. To play the game, participants will dance to the dance moves shown on the screen and as they get each move right, they will be awarded points (please see attached picture for the proposed interface design and system setup). The RGB webcams will be used to capture body movements and provide immediate/spontaneous feedback on the correctness of the movements. It will be affixed to the laptop. The participants' faces will not be captured.
- There will be no device for the participants to take home. The participants will only play the game in LB SACs (not in their homes).
- For this study, the participant will play the game individually, and under the observation of a RA/RN to ensure safety. No group play will be conducted in the pilot study. Before playing, they will be briefed on how to play in a language they understand.
SinDance Group.
- One face-to-face briefing session will be offered to participants in the SinDance group. The session will be conducted by the RN/RA. As part of promoting physical activity and safe exercise for older adults, the RN/RA will provide general guidance to older people on the benefits of physical activity (e.g.the recommended duration for physical activity, which will yield health benefits, and therefore, participants will play the exergame for 3 times a week and each session about 30 mins) and how to exercise safely (e.g. don't exercise if you feel unwell or very tired, wear appropriate footwear, warm up before exercise and cool down and stretch after exercise, etc.). This education will be provided to intervention group only. He/She will also teach the participants on how to navigate the SinDance exergame system, and how to choose between different levels of dance and play modes. It is estimated that the session will last for 20 minutes.
- To achieve adequate exercise volume, participants will be asked to engage in the newly developed SinDance 3 times a week for 6 weeks. Each session will last for about 30-40 mins, including 5 mins warm up exercise before the game and 5 mins cool down exercise afterwards. Therefore, if the participant does not stop halfway through or end the game early, the actual playing time for each participant will be about 20-30 minutes.
- To play the game, participants will dance to the dance moves shown on the screen (on the external monitor or the projected screen) and as they get each move right, they will be awarded points. The more accurate their moves are, the more points they get in the game.
- During the gameplay, the participants will be instructed to stop and rest if they are tired, and to dance on their own without the physical assistance from others during their play. A RN/RA will be on site to observe the safety of exergaming and to help resolve technical issues as they arise.
Control Group.
- Participants in the control group will attend usual activities offered by the senior activity centres. The control group will be offered an opportunity to play the SinDance exergame after completing the last data collection (i.e. 3-months from baseline).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 120344
- Lions Befrienders Active Ageing Centre @ CLEMENTI 344
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Singapore, Singapore, 120366
- Lions Befrienders Active Ageing Centre @ CLEMENTI 366/367
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Singapore, Singapore, 121420
- Lions Befrienders Active Ageing Centre @ CLEMENTI 420A
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Singapore, Singapore, 330032
- Lions Befrienders Active Ageing Centre @ Bendemeer 32
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Singapore, Singapore, 523499
- Lions Befrienders Active Ageing Centre @ Tampines 499C
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 60 and above
- Living in the community
- Independent without use of walking aids
- able to read and understand English or Chinese
- TUG < 30s
- Mini-Cog test score of 3 and above
Exclusion Criteria:
Are suffering from mental disorders or cognitive impairment that will prevent individuals from understanding the study and performing the exergame correctly and safely (e.g. Alzheimer's disease)
- Mini-Cog less than 3
have a pre-existing medical condition that prohibits exercise, or prevents the individual from performing the exergame correctly and safely, including but not limited to:
- chest pain or chest tightness during physical activities (e.g. walking, climbing stairs, doing household chores or similar activities
- heart failure
- currently experience dizziness or light-headedness, uncontrolled/unstable high blood pressure
have physical limitations, for examples:
- wheelchair bound
- pain, stiffness or swelling that will prevent the individual from doing what he/she wants or need to do
- feel unsteady, use an assistive device while standing or walking
- TUG equal or more than 30 seconds
- have visual or hearing impairments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SinDance
Participants in the SinDance group will attend an educational briefing session on the importance of exercising, and participate in a 6-week SinDance exergame intervention
|
One face-to-face briefing session (20 min) will be offered to participants in the SinDance group as part of promoting physical activity and safe exercise for older adults. Participants will be asked to engage in SinDance 3 times a week for 6 weeks. Each session will last for about 30-40 mins, including 5 mins warm up exercise before the game and 5 mins cool down exercise afterwards. All the game play sessions will be conducted in LB centres. Each participant will play the game individually. To play the game, participants will dance to the dance moves shown on the screen (on the external monitor or the projected screen) and as they get each move right, they will be awarded points. The more accurate their moves are, the more points they get in the game. During the gameplay, the participants will be instructed to stop and rest if they are tired. A RN/RA will be on site to observe the safety of exergaming and to help resolve technical issues as they arise. |
|
No Intervention: Control
Participants in the control group will attend usual activities offered by the senior activity centres.
The control group will be offered an opportunity to play the SinDance exergame after completing the last data collection (i.e.
3-months from baseline).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Fall Efficacy Scale International (short FES-I)
Time Frame: Baseline
|
Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).
|
Baseline
|
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Short Fall Efficacy Scale International (short FES-I)
Time Frame: 6 weeks from baseline
|
Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).
|
6 weeks from baseline
|
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Short Fall Efficacy Scale International (short FES-I)
Time Frame: 3 months from baseline
|
Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).
|
3 months from baseline
|
|
15-item Geriatric Depression Scale (GDS-15)
Time Frame: Baseline
|
Scores range from 0-15, and higher scores indicate a worse outcome (depression).
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Baseline
|
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15-item Geriatric Depression Scale (GDS-15)
Time Frame: 6 weeks from baseline
|
Scores range from 0-15, and higher scores indicate a worse outcome (depression).
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6 weeks from baseline
|
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15-item Geriatric Depression Scale (GDS-15)
Time Frame: 3 months from baseline
|
Scores range from 0-15, and higher scores indicate a worse outcome (depression).
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3 months from baseline
|
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Frenchay Activities Index (FAI)
Time Frame: Baseline
|
Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)
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Baseline
|
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Frenchay Activities Index (FAI)
Time Frame: 6 weeks from baseline
|
Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)
|
6 weeks from baseline
|
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Frenchay Activities Index (FAI)
Time Frame: 3 months from baseline
|
Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)
|
3 months from baseline
|
|
Five times sit-to-stand test (FTSTS)
Time Frame: Baseline
|
A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)
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Baseline
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Five times sit-to-stand test (FTSTS)
Time Frame: 6 weeks from baseline
|
A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)
|
6 weeks from baseline
|
|
Five times sit-to-stand test (FTSTS)
Time Frame: 3 months from baseline
|
A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)
|
3 months from baseline
|
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Time Up & Go Test (TUG)
Time Frame: Baseline
|
A longer time to complete the test indicates a worse outcome (poorer mobility)
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Baseline
|
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Time Up & Go Test (TUG)
Time Frame: 6 weeks from baseline
|
A longer time to complete the test indicates a worse outcome (poorer mobility)
|
6 weeks from baseline
|
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Time Up & Go Test (TUG)
Time Frame: 3 months from baseline
|
A longer time to complete the test indicates a worse outcome (poorer mobility)
|
3 months from baseline
|
|
Functional Reach Test
Time Frame: Baseline
|
A longer reach distance indicates a better outcome (better balance)
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Baseline
|
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Functional Reach Test
Time Frame: 6 weeks from baseline
|
A longer reach distance indicates a better outcome (better balance)
|
6 weeks from baseline
|
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Functional Reach Test
Time Frame: 3 months from baseline
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A longer reach distance indicates a better outcome (better balance)
|
3 months from baseline
|
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Modified Barthel ADL Index
Time Frame: Baseline
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Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)
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Baseline
|
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Modified Barthel ADL Index
Time Frame: 6 weeks from baseline
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Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)
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6 weeks from baseline
|
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Modified Barthel ADL Index
Time Frame: 3 months from baseline
|
Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)
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3 months from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance (for SinDance group only)
Time Frame: Each session during the 6-week intervention (total of 18 sessions)
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Their attendance for each exergame session will be recorded
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Each session during the 6-week intervention (total of 18 sessions)
|
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Level of motivation (for SinDance group only)
Time Frame: Each session during the 6-week intervention (total of 18 sessions)
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Participants will be asked to rate their level of motivation to play the exergame after each exergame session on a five-point Likert scale ranging from '1 = very low' to '5 = very high'.
|
Each session during the 6-week intervention (total of 18 sessions)
|
|
Level of enjoyment (for SinDance group only)
Time Frame: Each session during the 6-week intervention (total of 18 sessions)
|
Participants will be asked to rate their level of enjoyment during the exergame after each exergame session on a five-point Likert scale ranging from '1 = very low' to '5 = very high'.
|
Each session during the 6-week intervention (total of 18 sessions)
|
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Duration of play (for SinDance group only)
Time Frame: Each session during the 6 week intervention (total of 18 sessions)
|
Their duration of play for each exergame session will be recorded
|
Each session during the 6 week intervention (total of 18 sessions)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ying Jiang, PhD, Alice Lee Centre for Nursing Studies, National University of Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NUHS Seed Grant Call Sep 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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