UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048286 |
|---|---|
| Receipt number | R000055024 |
| Scientific Title | A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/07/05 16:41:18 |
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Basic information
Public title
A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Acronym
A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Scientific Title
A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Scientific Title:Acronym
A research project on confirming the effects of exercise guidance methods for middle and senior generations using SNS and improving exercise habits
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the effect of using SNS (effect on continuation of exercise and effect on motor function) in an environment where there are few opportunities for face-to-face instruction.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to confirm the effect of using SNS (effect on continuation of exercise and effect on motor function) in an environment where there are few opportunities for face-to-face instruction.
Trainers usually teach participants about 1-2 hours (for example, twice a month) at an exercise event. but, this method does not lead to the establishment of exercise effects, so a more effective approach is needed.
This time, we will collect basic data on changes in cognitive behavior and motor function from groups that participated only in the event and groups that participated in the exercise event and watched SNS videos. From the results, we will investigate the effectiveness of using SNS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise rate = days of exercise / days of exercise
Key secondary outcomes
Confirm the change in consciousness (self-efficacy) at the start and end by questionnaire. In addition, abdominal circumference and BMI changes at the start and end, changes in walking function, changes in physical fitness measurement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The research period (intervention period) is 6 weeks (42 days), and participants participate in 4 exercise events (first time, 2nd week, 4th week, 6th week), provide exercise guidance for trainers, and use a smartphone (smartphone). Exercise videos are distributed to the LINE app) twice a week.
Interventions/Control_2
The research period (intervention period) will be 6 weeks (42 days), and participants will participate in 4 exercise events (1st, 2nd, 4th, and 6th weeks) and trainers will be instructed in exercise.
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Healthy people: Those who can exercise training for the elderly
2 Age must be between 50 and 85 years
3 Those who can walk independently and perform simple exercises in daily life,
4 I use the LINE app on my smartphone everyday.
5 Persons who have received sufficient explanation in participating in this study and obtained written consent at their own discretion.
Key exclusion criteria
1 Person who has a disease and is prohibited from exercising by a doctor
2 Persons requiring care and support
3 Excluded persons (those who cannot walk or stand on one leg) judged by the person in charge of the exercise event implementation facility and experts (health teachers)
4 Persons wearing internal equipment such as pacemakers
5 Others who are judged to be inappropriate by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | hidetaka |
| Middle name | |
| Last name | hisano |
Organization
be awake company limited
Division name
-
Zip code
253-0054
Address
2-11-24-308 higashikaiganminami, chigasaki, Kanagawa 253-0054, Japan
TEL
0467-33-4388
h.hisano@beawake.co.jp
Public contact
Name of contact person
| 1st name | hidetaka |
| Middle name | |
| Last name | hisano |
Organization
be awake company limited
Division name
-
Zip code
253-0054
Address
2-11-24-308 higashikaiganminami, chigasaki, Kanagawa 253-0054, Japan
TEL
0467-33-4388
Homepage URL
h.hisano@beawake.co.jp
Sponsor or person
Institute
be awake company limited
Institute
Department
Personal name
Funding Source
Organization
be awake company limited
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
NPO community health plan
Address
2-7-23 nanokamachi, yamagata-city, yamagata 990-0042, Japan
Tel
0463-93-1121
ayoko5270@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 20 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055024
