UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051861 |
|---|---|
| Receipt number | R000059148 |
| Scientific Title | Verification of an outing support project using a smartphone application for older adults living in the community |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2024/02/21 16:27:05 |
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Basic information
Public title
Verification of outing support program for older adults.
Acronym
Verification of outing support program for older adults.
Scientific Title
Verification of an outing support project using a smartphone application for older adults living in the community
Scientific Title:Acronym
Verification of an outing support project with a smartphone application for older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of an outing support project using a smartphone application for elderly people living in the community
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes after intervention in subjectively measured total physical activity
Key secondary outcomes
Changes after intervention in objectively measured physical activity.
Changes after intervention in frequency of outing, social isolation, and self-efficacy assessed by questionnaire
Changes after intervention in steps measured by smartphone.
Changes after intervention in walking speed, grip strength, and CS-30.
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
Use of a smartphone group-based application in 12 weeks.
Initial training sessions (application use class and health class), Wearing a triaxial accelerometer (about 1 week from the start of the intervention and before the end of the intervention).
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women over 65 years old
2. Not restricted from walking by a physician
3. Walking independently
4. Able to type text on a smartphone
Key exclusion criteria
1. Persons who unable to participate safely in a physical activity program based on responses to PAR-Q.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
223-0061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
yoguma@keio.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Tabira |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
223-0061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
Homepage URL
kjump617@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Yuko Oguma
Funding Source
Organization
Fujisawa city Hall
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujisawa City Hall, A10 Lab Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Sports Medicine Research Center, Keio University
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
Tel
045-566-1090
smrc-info@ml.keio.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 | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
41
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 | 05 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059148
