Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05227040 |
| Other study ID # |
NDMC_Chulab_002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
April 30, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
National Defense Medical Center, Taiwan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
