- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05227040
Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 114201
- National defense medical center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: Nintendo Ring Fit Adventure Exergame Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Running Completion Time
Time Frame: 4 week
|
Investigators researched to use a 1600-meter running for testing.
|
4 week
|
Collaborators and Investigators
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NDMC_Chulab_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Mood Disorders
-
Joliet Center for Clinical ResearchAbbottCompleted
-
VA Office of Research and DevelopmentCompleted
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
-
Hanyang UniversityDSM-Firmenich AGActive, not recruiting
-
National Institute of Mental Health (NIMH)Completed
-
Baskent UniversityZİYAFET UĞURLUCompletedDisaster; Personality | Disorder, MoodTurkey
-
Fayoum University HospitalCompletedKetamine-Induced Mood DisorderEgypt
-
Shanghai Mental Health CenterActive, not recruitingMood Disorders in Children and AdolescentsChina
-
Mayo ClinicCompletedMood Disorders in Children and AdolescentsUnited States
Clinical Trials on Nintendo Ring Fit Adventure Exergame
-
Universidad de CórdobaActive, not recruiting
-
University of Kansas Medical CenterHRSA/Maternal and Child Health BureauCompleted
-
Manuel Gomez, MD, MSc.CompletedArthropathy of Knee JointCanada
-
Istanbul University - Cerrahpasa (IUC)CompletedHeart Failure | Older PeopleTurkey
-
University Hospital of FerraraCompletedMultiple Sclerosis | Postural BalanceItaly
-
University of BaselPsychiatric Hospital of the University of Basel; University Children's Hospital...UnknownDepression | Quality of Life | Sleep | Crohn Disease | Ulcerative Colitis | Motor ActivitySwitzerland
-
Queen's UniversityWalmartCompletedChronic SchizophreniaCanada
-
Örebro County CouncilNorrbacka-Eugenia Foundation; Uppsala-Örebro Regional Research CouncilCompletedMultiple SclerosisSweden
-
University of British ColumbiaCompletedBelow Knee AmputationCanada
-
The Children's Hospital of Zhejiang University...Not yet recruitingCongenital Heart Disease | Physical InactivityChina