UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043397 |
|---|---|
| Receipt number | R000049547 |
| Scientific Title | A study investigating the synergetic effect between a walking show and an exercise program |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/02/23 11:18:16 |
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Basic information
Public title
A study investigating the synergetic effect between a walking show and an exercise program
Acronym
A study investigating the synergetic effect between a walking show and an exercise program
Scientific Title
A study investigating the synergetic effect between a walking show and an exercise program
Scientific Title:Acronym
A study investigating the synergetic effect between a walking show and an exercise program
Region
| Japan |
Condition
Condition
Non applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the synergetic effect between a walking show and an exercise program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The locomotive syndrome risk test
Key secondary outcomes
SF8, grip power, Time up and go test, walking speed (usual, maximum)
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
An exercise program:2 hours * 2 times/week, a total of 2 months
Interventions/Control_2
An exercise program:2 hours * 2 times/week, a total of 2 months, and a walking show
Interventions/Control_3
a walking show
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
| 60 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. community dwellers
2. subjects who could write self-administrated questionnaires
3. subjects who agreed with the examination
Key exclusion criteria
1. subjects who were admitted to the hospital within on months
2. subjects who had surgery on their spine or lower extremities within 3 months
3. subjects whom researchers judged inappropriate as participants
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Yamada |
Organization
The University of Tokyo Hospital
Division name
Planning and Information Management Department
Zip code
113-8655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL
+81338155411
kyamad-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Yoshizumi |
Organization
Social Welfare Corporation, Jikokai
Division name
Community support service center
Zip code
861-2231
Address
1080 Yasunaga, Mashiki-cho, Kamimashiki_gun, Mumamoto
TEL
096-286-4192
Homepage URL
hiro.chiiki@jikou-kai.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Corporation, Jikokai
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
Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2021 | Year | 06 | Month | 01 | 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
147
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of participants and implmetation of the research have been delayed due to the COVID-19 pandemic and the water disaster in Kumamoto, however, we finished the recruitment and will proceed the study.
Management information
Registered date
| 2021 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049547
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
