UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050943 |
|---|---|
| Receipt number | R000058067 |
| Scientific Title | Exploratory study to explore the effectiveness of "MyEverycise" in improving exercise persistence to prevent dementia and frailty |
| Date of disclosure of the study information | 2023/04/28 |
| Last modified on | 2025/04/27 11:34:33 |
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Basic information
Public title
Exploratory study to explore the effectiveness of "MyEverycise" in improving exercise persistence to prevent dementia and frailty
Acronym
The effectiveness of "MyEverycise" in improving exercise persistence
Scientific Title
Exploratory study to explore the effectiveness of "MyEverycise" in improving exercise persistence to prevent dementia and frailty
Scientific Title:Acronym
The effectiveness of "MyEverycise" in improving exercise persistence
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To realize a long-lived society where people can enjoy a long life, it is necessary to overcome dementia and frailty problems among the elderly. Continuous exercise is attracting attention as one way to prevent dementia and frailty. The difficulty for individuals to continue exercising daily has long been an issue. We have developed a method of continuous exercise using "daily activities" as a cue and named it MyEverycise from "My Everyday Exercise" and registered it as a trademark. We have been preparing for the validation of this method. This study will confirm that this MyEverycise is effective for continuing daily exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
With the cooperation of local governments and universities, we will encourage exercise based on the MyEverycise in subjects aged 20 to 80 (age and gender will be interviewed) and conduct a one-month effectiveness exploratory study. For the evaluation, we will use the Physical Activity Frequency Questionnaire, which we have developed a Japanese version of and which has already been verified for inter-rater reliability and reproducibility (the period to be evaluated will be modified to a one-month average). Regarding the endpoint of this study, we defined "improvement in exercise persistence" as an increase in the frequency of exercise after the intervention compared to before the intervention. Otherwise, there was no "improvement in exercise persistence". Statistical analysis of the change in exercise frequency before and after the intervention will be conducted, with "improvement in persistence" in "light exercise" as the primary endpoint. Sub-analysis will be conducted by age group. One month after the end of the intervention period, exercise retention will be assessed using the same physical activity frequency questionnaire, and statistical analysis will be conducted (post-observation evaluation).
Key secondary outcomes
Statistical analysis of the change in exercise frequency before and after the intervention will be conducted for each secondary endpoint of "moderate exercise" and "intense exercise. Sub-analysis will be conducted by age group. One month after the end of the intervention period, exercise retention will be assessed using the same physical activity frequency questionnaire, and statistical analysis will be conducted (post-observation evaluation).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Encourage exercise based on "MyEverycise," a method of continuous exercise using "activities of daily living" as a cue.
Interventions/Control_2
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A total of 30 subjects (8 to 12 subjects in each generation) will be recruited from university students (younger generation around 20 years old), working people working for local governments and companies (a wide range of generations from 30 to 64 years old), and older adults (65 to 80 years old) visiting the National Center for Geriatrics and Gerontology.
Key exclusion criteria
In the physical activity frequency survey, those who exercise more than three times a week in the "light exercise" section of the Physical Activity Frequency Questionnaire were excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Sato |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Aging Neurobiology
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi
TEL
+81562462311
nsato@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Sato |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Aging Neurobiology
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi
TEL
+81562462311
Homepage URL
nsato@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
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
National Center for Geriatrics and Gerontology Ethics Committee
Address
7-430, Morioka, Obu, Aichi
Tel
+81562462311
yaday@ncgg.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1652
Org. issuing International ID_1
National Center for Geriatrics and Gerontology
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 28 | 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
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
20 people participated in this study.
Management information
Registered date
| 2023 | Year | 04 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058067
