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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05227040
Study type Interventional
Source National Defense Medical Center, Taiwan
Contact
Status Completed
Phase N/A
Start date January 1, 2021
Completion date April 30, 2021

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