AgedNCT05411042
Benefits of Digital Dance Game by Older Adults
A study testing Dance somatosensory game in people with Aged, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study aims to examine the clinical efficacy of dancing somatosensory videogames in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of… Read more about this study
- Who is it for?
- Ages 55 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Dance somatosensory game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2020to 20 Mar 2022
- 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 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years old.
- More than 6 years of formal education.
- Can communicate in Mandarin and Taiwanese.
- Can accept MRI examination without claustrophobia.
- Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.
Who cannot join
- Have engaged in any video dancing games in the past three months.
- Engaged in video dancing games more than three times per year in the past three years.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: Benefits of Digital Dance Game Participation by Older Adults on Brain Gray Matter Volume, Physical Function, Cognitive Performance, and Quality of Life: a Randomized Controlled Trial.
This study aims to examine the clinical efficacy of dancing somatosensory videogames in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.
Read the detailed description
This randomized controlled trial followed the CONSORT guidelines to compare the clinical efficacy of the intervention group with the control group. The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
The primary outcome of the trial was changes of gray matter volume of the brain done by 3T brain magnetic resonance imaging during the study period. The secondary outcomes included cognitive performance, quality of life, physical activities, resilience, and demoralization. For all outcome variables, the measurements at the baseline and 6-month follow-up were examined by a random intercept and a fixed slope, and the effect of the intervention was estimated by using the Generalized Estimating Equation.
- Conditions
- Aged
- Being tested
- Dance somatosensory game
- Keywords
- Digital dance game, older adults, Brain gray matter volume, cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance somatosensory gameDevice
dance somatosensory game (DSG), DANZ BASE developed by International Games System Company
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental group intervened a dance somatosensory game (DSG), DANZ BASE developed by International Games System Company, at the Xinzhuang health center, which is a local bureau with outpatient clinic. The participants in experimental group played twice a week, each time requiring at least lasting 30 minutes, for half of a year. Receives: Device: Dance somatosensory game |
| Control group | No intervention | The control group only performed routine data collection; the research assistant asked the subjects about their usual activities by telephone every month to understand their physical activity in this half of the year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MRI study
Change in MRI study from baseline to 6 months in the intervention group.
Measured: from baseline to 6 months
Secondary outcomes (5)
Montreal Cognitive Assessment (MoCA)
Cognitive function measure by MoCA , which comprise a 30-question test.Score range: 0-30, and a score of 26 and higher is considered normal.
Measured: from baseline to 6 months
EuroQol instrument (EQ-5D)
Quality of life measure by EQ-5D, which include five questions on mobility, self care, pain, usual activities, and psychological status.There are three level of the answers for each question, the maximum score of 1 refers to the best condition without problem, and higher scores refers more severe of the issue. Moreover, the visual analogue scale (VAS) which from 0-100, higher score indicating better health status.
Measured: from baseline to 6 months
International Physical Activity Questionnaire (IPAQ)
Physical activity measured by IPAQ, indicates that spent being physically active within the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations.
Measured: from baseline to 6 months
Brief Resilience Scale (BRS)
Resilience measured by BRS to assess ability to bounce back or recover from stress and adversity. Score range: 6-30, and higher scores refers to higher level of resilience.
Measured: from baseline to 6 months
Demoralization Scale-Mandarin Version (DS-MV)
Demoralization measure by DS-MV, comprised 24 items and each rated on a five-point Likert scale.Score range: 0-96, and cut-off point score ≥30 was considered to identified demoralization.
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start31 Aug 2020
- Primary completion25 Oct 2021
- Study completion20 Mar 2022
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 AgedStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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
- Model description
- The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang-Kung Chen, M.D., PhD, Study director, Aging and Health Research Center, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411042
- Sponsor's protocol ID
- YM108123F_D
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tung HH, Kuo CY, Lee PL, Chang CW, Chou KH, Lin CP, Chen LK. Efficacy of Digital Dance on Brain Imagery, Cognition, and Health: Randomized Controlled Trial. J Med Internet Res. 2024 Jul 30;26:e57694. doi: 10.2196/57694.
PubMed 39078687
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Digital Dance Game Participation by Older Adults on Brain Gray Matter Volume, Physical Function, Cognitive Performance, and Quality of Life: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05411042
- Acronym / sponsor ID
- YM108123F_D
- Conditions
- Aged
- Keywords
- Digital dance game, older adults, Brain gray matter volume, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 8 Jun 2022 (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.
This study aims to examine the clinical efficacy of dancing somatosensory videogames in improving physical health, cognitive performance, happiness, laboratory biomarkers, and structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial design, and hopefully to expand the scope of healthy aging intervention activities with strong scientific evidence.
Detailed description
This randomized controlled trial followed the CONSORT guidelines to compare the clinical efficacy of the intervention group with the control group. The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
The primary outcome of the trial was changes of gray matter volume of the brain done by 3T brain magnetic resonance imaging during the study period. The secondary outcomes included cognitive performance, quality of life, physical activities, resilience, and demoralization. For all outcome variables, the measurements at the baseline and 6-month follow-up were examined by a random intercept and a fixed slope, and the effect of the intervention was estimated by using the Generalized Estimating Equation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Dance somatosensory gameThe experimental group intervened a dance somatosensory game (DSG), DANZ BASE developed by International Games System Company, at the Xinzhuang health center, which is a local bureau with outpatient clinic. The participants in experimental group played twice a week, each time requiring at least lasting 30 minutes, for half of a year. |
| Control group | No intervention | –The control group only performed routine data collection; the research assistant asked the subjects about their usual activities by telephone every month to understand their physical activity in this half of the year. |
Who may qualify
- Ages
- 55 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 55 years old.
- More than 6 years of formal education.
- Can communicate in Mandarin and Taiwanese.
- Can accept MRI examination without claustrophobia.
- Can understand the research process, meet the requirements of the research, and can sign the consent form and participate in the subject.
Key exclusion criteria (2 listed)
- Have engaged in any video dancing games in the past three months.
- Engaged in video dancing games more than three times per year in the past three years.
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 |
|---|---|---|
| Dance somatosensory gamedance somatosensory game (DSG), DANZ BASE developed by International Games System Company | Device | Intervention group |
Primary outcome
Change in MRI study
Time frame: from baseline to 6 months
Change in MRI study from baseline to 6 months in the intervention group.
5 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: from baseline to 6 months
EuroQol instrument (EQ-5D)
Time frame: from baseline to 6 months
International Physical Activity Questionnaire (IPAQ)
Time frame: from baseline to 6 months
Brief Resilience Scale (BRS)
Time frame: from baseline to 6 months
Demoralization Scale-Mandarin Version (DS-MV)
Time frame: from baseline to 6 months
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 10 Jun 2022.
- Derived from this study: PubMed 39078687Tung HH, Kuo CY, Lee PL, Chang CW, Chou KH, Lin CP, Chen LK. Efficacy of Digital Dance on Brain Imagery, Cognition, and Health: Randomized Controlled Trial. J Med Internet Res. 2024 Jul 30;26:e57694. doi: 10.2196/57694.
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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.
Liang-Kung Chen, M.D., PhD study director
Aging and Health Research Center, National Yang-Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance somatosensory game in people with Aged, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 10 Jun 2022. 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 Taiwan. 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?
Change in MRI study (time frame: from baseline to 6 months). 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 NCT05411042, 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 10 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.