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Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time

Primary Purpose

Sleep Quality, Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nintendo Ring Fit Adventure Exergame
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Quality focused on measuring Exergaming, Cardiac force index, Running, Physical activity, Sleep quality, Mood disorders

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • National Defense Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nintendo Ring Fit Adventure Exergame Group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Running Completion Time
Investigators researched to use a 1600-meter running for testing.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2022
Last Updated
February 5, 2022
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05227040
Brief Title
Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Mood Disorders
Keywords
Exergaming, Cardiac force index, Running, Physical activity, Sleep quality, Mood disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nintendo Ring Fit Adventure Exergame Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Nintendo Ring Fit Adventure Exergame
Intervention Description
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.
Primary Outcome Measure Information:
Title
Running Completion Time
Description
Investigators researched to use a 1600-meter running for testing.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
National Defense Medical Center
City
Taipei
ZIP/Postal Code
114201
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35315780
Citation
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.
Results Reference
derived

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Effect of the Nintendo Ring Fit Adventure Exergame on Running Completion Time

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