UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049221 |
|---|---|
| Receipt number | R000056058 |
| Scientific Title | Effects of Gamification App-Based Exercise on Self-Efficacy |
| Date of disclosure of the study information | 2022/10/18 |
| Last modified on | 2024/04/26 11:40:34 |
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Basic information
Public title
Investigating the Relationship between Exercise and Self-Efficacy Using an App Game
Acronym
Investigating the Relationship between Exercise and Self-Efficacy Using an App Game
Scientific Title
Effects of Gamification App-Based Exercise on Self-Efficacy
Scientific Title:Acronym
Effects of Gamification App-Based Exercise on Self-Efficacy
Region
| Japan |
Condition
Condition
Self-efficacy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of gamification application-based app game exercise on self-efficacy
Basic objectives2
Others
Basic objectives -Others
To determine the impact of gamification application-based app game exercise on self-efficacy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy of exercise after 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise using an app game for 30 minutes per session, twice a week for 4 weeks
Interventions/Control_2
Walking for 30 minutes per session, twice a week for 4 weeks
Interventions/Control_3
No exercise instructions for 4 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women with no exercise habits
Key exclusion criteria
Patients with a history or current medical condition that would be aggravated by exercise.
Those with a history or current history of psychiatric disorders
Women who are pregnant or may become pregnant
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takeda |
| Middle name | |
| Last name | Eriko |
Organization
Hamamatsu University School of Medicine
Division name
Graduate School of Medicine, Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
TEL
053-435-2510
etakeda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Suzuki |
| Middle name | |
| Last name | Megumi |
Organization
Hamamatsu University School of Medicine
Division name
1-20-1 Handayama, Higashi-ku, Hamamatsu City
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
TEL
090-9944-4106
Homepage URL
F22003@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Graduate School of Medicine, Nursing
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
Tel
053-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R4-11
Org. issuing International ID_1
Shizuoka College of Medical Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡医療科学専門大学校
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently submitted to and under review by the Japanese Journal of Maternal Health.
Date of the first journal publication of results
Baseline Characteristics
The average age of participants overall was 26.7 years. The gaming application group averaged 28.1 years, the walking group averaged 23.4 years and the no exercise instructions group averaged 28.1 years. All genders were female.
Participant flow
Sixty-four people were provisionally enrolled in the study. Of these, one had exclusion criteria and one subsequently no longer responded, leaving 62 who completed full enrolment.
These 62 participants were randomly allocated to three groups: 22 in the game application group, 19 in the walking group and 21 in the no exercise instructions group. Of the 22 in the game app group, one was lost to follow-up and 21 were included in the analysis. Of the 19 participants in the walking group, two were lost to follow-up and 17 were included in the analysis. All 21 participants in the no exercise instructions group were included in the analysis.
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 21 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 24 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056058
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