Sleep QualityNCT05227040
Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time
A study testing Nintendo Ring Fit Adventure Exergame in people with Sleep Quality and Mood Disorders, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
The coronavirus disease 2019 (COVID-19) outbreak has not only changed the lifestyles of people globally but has also resulted in other challenges, such as the requirement of self-isolation and distance learning. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Mood Disorders
- What is being tested?
- Nintendo Ring Fit Adventure Exergame
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 30 Apr 2021
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- students who were over 20 years old and did not have chronic diseases;
- students who were able to complete the 1600-meter outdoor run before and after the intervention;
- students who understood and agreed with the research purpose and signed the consent form.
Who cannot join
- chronic diseases or medications prescribed for over 6 months;
- restricted movement or failure to complete the 1600-meter run before and/or after the intervention
- wearable devices that were not worn well or inability to calculate the cardiac force index (CFI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time and Psychological Factors Among University Students Engaging in Distance Learning During the COVID-19 Pandemic: A Randomized Prospective Study
The coronavirus disease 2019 (COVID-19) outbreak has not only changed the lifestyles of people globally but has also resulted in other challenges, such as the requirement of self-isolation and distance learning. The COVID-19 pandemic has resulted in an inability to go out to exercise and a reduction in movement, so the demand for exercise at home has increased. To investigate the relationships between a Nintendo Ring Fit Adventure (RFA) intervention and improvements in running time, cardiac force index (CFI), centimeters per beat (CMPB), sleep quality, and mood disorders.
Read the detailed description
In this study, a pre-test-post-test control group design was used to collect data from healthy populations in the northern region. The intervention groups were simply randomly assigned to investigate the cardiac force index, sleep quality and mood disorders before and after 4 weeks of Ring Fit Adventure intervention. The study will use the wearable Medtronic ZephyrTM BioHarness 3.0 and Q-Band HR3 (Q-69HR) bracelet. The device is used for physiological parameter collection. Heart rate, acceleration, activity acceleration, activity volume, CFI were recorded during a 1600 m run for pre-post-test.
In this study, ZephyrTM BioHarness 3.0 and a Q-Band HR3 (Q-69HR) bracelet were used to collect as physiological parameters. Heart rate, acceleration, activity, cardio index and cardio force ratio were recorded before and after 1600 meters.
In order to know whether there are relevant influencing factors for the mental strength indicators in this study, the gender, age, height, weight, neck circumference, waist circumference, hip circumference, smoking and drinking habits, and family medical history of the case will be recorded, and the GPS track during running will be recorded before and after each running. Time, distance, ambient temperature and humidity, weight, neck circumference, waist circumference, hip circumference, blood pressure, blood oxygen, heart rate, etc., and analyze the relationship between parameters. The above cases are measured and recorded every time they run. This is a longitudinal cohort study. The statistics will be repeated variable analysis and generalized linear model, etc., to explore the norm estimation of CFI in different ages and genders.
Before using Microsoft Office 365 Excel for data archiving and analytical processing, please study the data, including the compilation of Zephyr BioHarness data and the calculation of the heart rate index. According to statistical analysis methods, in descriptive statistical analysis, categorical data are presented in numbers and percentages, while continuous data are presented in mean and standard deviation presentations.
Inference statistics will be analyzed using paired t-tests, ANOVA, and generalized linear models to analyze cardiac force before and after the intervention. If the data were not normally distributed, the analysis was performed using the Wilcoxon signed-rank test. The significance level for this study was set at α = 0.05. All analytical data pipelines will use IBM SPSS Statistics version 26. The data has been delinked when the case is received, and personal data cannot be recalled in any way. The received data is stored in a server with account and password control.
- Conditions
- Sleep Quality, Mood Disorders
- Being tested
- Nintendo Ring Fit Adventure Exergame
- Keywords
- Exergaming, Cardiac force index, Running, Physical activity, Sleep quality, Mood disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mood Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Ring Fit Adventure ExergameDevice
Participants in the RFA group were required to exercise for 30 minutes three times per week (in adventure mode) for 4 weeks. The initial exercise intensity was set according to the instructions given by the virtual coach during the first game and was gradually adjusted according to the game instructions. The research continued to track the RFA group subjects and continued to encourage the completion of 4 weeks of physical activity training.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Ring Fit Adventure Exergame Group | Experimental | Participants in the RFA group were required to exercise for 30 minutes three times per week (in adventure mode) for 4 weeks. The initial exercise intensity was set according to the instructions given by the virtual coach during the first game and was gradually adjusted according to the game instructions. The research continued to track the RFA group subjects and continued to encourage the completion of 4 weeks of physical activity training. Receives: Device: Nintendo Ring Fit Adventure Exergame |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running Completion Time
Investigators researched to use a 1600-meter running for testing.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 Sleep QualityStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WU, YI - SYUAN, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227040
- Sponsor's protocol ID
- NDMC_Chulab_002
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu YS, Wang WY, Chan TC, Chiu YL, Lin HC, Chang YT, Wu HY, Liu TC, Chuang YC, Wu J, Chang WY, Sun CA, Lin MC, Tseng VS, Hu JM, Li YK, Hsiao PJ, Chen CW, Kao HY, Lee CC, Hsieh CB, Wang CH, Chu CM. Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time and Psychological Factors Among University Students Engaging in Distance Learning During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Serious Games. 2022 Mar 22;10(1):e35040. doi: 10.2196/35040.
PubMed 35315780
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time and Psychological Factors Among University Students Engaging in Distance Learning During the COVID-19 Pandemic: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT05227040
- Acronym / sponsor ID
- NDMC_Chulab_002
- Conditions
- Sleep Quality, Mood Disorders
- Keywords
- Exergaming, Cardiac force index, Running, Physical activity, Sleep quality, Mood disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 7 Feb 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.
The coronavirus disease 2019 (COVID-19) outbreak has not only changed the lifestyles of people globally but has also resulted in other challenges, such as the requirement of self-isolation and distance learning. The COVID-19 pandemic has resulted in an inability to go out to exercise and a reduction in movement, so the demand for exercise at home has increased. To investigate the relationships between a Nintendo Ring Fit Adventure (RFA) intervention and improvements in running time, cardiac force index (CFI), centimeters per beat (CMPB), sleep quality, and mood disorders.
Detailed description
In this study, a pre-test-post-test control group design was used to collect data from healthy populations in the northern region. The intervention groups were simply randomly assigned to investigate the cardiac force index, sleep quality and mood disorders before and after 4 weeks of Ring Fit Adventure intervention. The study will use the wearable Medtronic ZephyrTM BioHarness 3.0 and Q-Band HR3 (Q-69HR) bracelet. The device is used for physiological parameter collection. Heart rate, acceleration, activity acceleration, activity volume, CFI were recorded during a 1600 m run for pre-post-test.
In this study, ZephyrTM BioHarness 3.0 and a Q-Band HR3 (Q-69HR) bracelet were used to collect as physiological parameters. Heart rate, acceleration, activity, cardio index and cardio force ratio were recorded before and after 1600 meters.
In order to know whether there are relevant influencing factors for the mental strength indicators in this study, the gender, age, height, weight, neck circumference, waist circumference, hip circumference, smoking and drinking habits, and family medical history of the case will be recorded, and the GPS track during running will be recorded before and after each running. Time, distance, ambient temperature and humidity, weight, neck circumference, waist circumference, hip circumference, blood pressure, blood oxygen, heart rate, etc., and analyze the relationship between parameters. The above cases are measured and recorded every time they run. This is a longitudinal cohort study. The statistics will be repeated variable analysis and generalized linear model, etc., to explore the norm estimation of CFI in different ages and genders.
Before using Microsoft Office 365 Excel for data archiving and analytical processing, please study the data, including the compilation of Zephyr BioHarness data and the calculation of the heart rate index. According to statistical analysis methods, in descriptive statistical analysis, categorical data are presented in numbers and percentages, while continuous data are presented in mean and standard deviation presentations.
Inference statistics will be analyzed using paired t-tests, ANOVA, and generalized linear models to analyze cardiac force before and after the intervention. If the data were not normally distributed, the analysis was performed using the Wilcoxon signed-rank test. The significance level for this study was set at α = 0.05. All analytical data pipelines will use IBM SPSS Statistics version 26. The data has been delinked when the case is received, and personal data cannot be recalled in any way. The received data is stored in a server with account and password control.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Ring Fit Adventure Exergame Group | Experimental | Device: Nintendo Ring Fit Adventure ExergameParticipants in the RFA group were required to exercise for 30 minutes three times per week (in adventure mode) for 4 weeks. The initial exercise intensity was set according to the instructions given by the virtual coach during the first game and was gradually adjusted according to the game instructions. The research continued to track the RFA group subjects and continued to encourage the completion of 4 weeks of physical activity training. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- students who were over 20 years old and did not have chronic diseases;
- students who were able to complete the 1600-meter outdoor run before and after the intervention;
- students who understood and agreed with the research purpose and signed the consent form.
Key exclusion criteria (3 listed)
- chronic diseases or medications prescribed for over 6 months;
- restricted movement or failure to complete the 1600-meter run before and/or after the intervention
- wearable devices that were not worn well or inability to calculate the cardiac force index (CFI).
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 |
|---|---|---|
| Nintendo Ring Fit Adventure ExergameParticipants in the RFA group were required to exercise for 30 minutes three times per week (in adventure mode) for 4 weeks. The initial exercise intensity was set according to the instructions given by the virtual coach during the first game and was gradually adjusted according to the game instructions. The research continued to track the RFA group subjects and continued to encourage the completion of 4 weeks of physical activity training. | Device | Nintendo Ring Fit Adventure Exergame Group |
Primary outcome
Running Completion Time
Time frame: 4 week
Investigators researched to use a 1600-meter running for testing.
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 22 Feb 2022.
- Derived from this study: PubMed 35315780Wu YS, Wang WY, Chan TC, Chiu YL, Lin HC, Chang YT, Wu HY, Liu TC, Chuang YC, Wu J, Chang WY, Sun CA, Lin MC, Tseng VS, Hu JM, Li YK, Hsiao PJ, Chen CW, Kao HY, Lee CC, Hsieh CB, Wang CH, Chu CM. Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time and Psychological Factors Among University Students Engaging in Distance Learning During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Serious Games. 2022 Mar 22;10(1):e35040. doi: 10.2196/35040.
- 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 Nintendo Ring Fit Adventure Exergame in people with Sleep Quality and Mood Disorders, run by National Defense Medical Center, Taiwan 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 3 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: finished, as of the sponsor's last update on 22 Feb 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?
Running Completion Time (time frame: 4 week). 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 NCT05227040, 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 22 Feb 2022.