UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050680 |
|---|---|
| Receipt number | R000057743 |
| Scientific Title | Research on monitoring of physical function activity during activity restriction |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2024/12/29 14:47:00 |
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Basic information
Public title
Research on monitoring of physical function activity during activity restriction
Acronym
Activity monitoring during activity restriction
Scientific Title
Research on monitoring of physical function activity during activity restriction
Scientific Title:Acronym
Observational study of activity levels during activity restriction
Region
| Japan |
Condition
Condition
Healthy and physical disabled who can walk
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the differences in the amount of activity in healthy and physically disabled subjects during their daily activities and in a restricted activity environment by measuring the amount of activity using an activity meter for several days.
Basic objectives2
Others
Basic objectives -Others
not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference or percentage change in the number of steps taken during daily activity and during activity limitation.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults who are able to walk.
Healthy individuals who are capable of normal social activities and who have a planned situation of limited activity.
Persons with physical disabilities who live at home and have planned activity days that allow for social activities and restricted activity situations such as spending the entire day at home.
Key exclusion criteria
Those who may change their planned activity schedule.
Persons who are unable to follow instructions.
Any other person whom the principal investigator or subinvestigator deems inappropriate to conduct this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Wada |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
a.ebata@hotmail.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Virtual shelter activity was analyzed in 10 healthy subjects. Biometric devices tracked steps and activity indices during sitting-rest and free time. Free time activity was significantly higher (p<0.05). Questionnaires indicated "solidarity" aided activity, with training guides and health equipment desired. Activity differences confirm the importance of supporting psychological and physical health in virtual shelters.
Results date posted
| 2024 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 30 | Day |
Other
Other related information
How to recruit subjects.
For healthy subjects, recruitment guidelines will be posted at the outpatient clinic of the Department of Rehabilitation Medicine, Keio University Hospital, and study participation will be accepted.
For physically disabled subjects, information will be provided to those who are potentially eligible, and a list of those who wish to explain and participate in the study will be compiled.
After confirming that all eligibility criteria are met and none of the exclusion criteria apply, a detailed explanation will be given in writing to those who wish to participate and consent will be obtained.
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057743
