UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051966 |
|---|---|
| Receipt number | R000059311 |
| Scientific Title | Enhancing Driving Ability in Older Adults Through Health Exercises and Physical Activity: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/08/22 |
| Last modified on | 2023/08/22 01:13:52 |
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Basic information
Public title
Enhancing Driving Ability in Older Adults Through Health Exercises and Physical Activity
Acronym
Effects of healthy exercise on maintaining and improving older adults driving ability
Scientific Title
Enhancing Driving Ability in Older Adults Through Health Exercises and Physical Activity: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of healthy exercise on maintaining and improving older adults driving ability: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the possibility of preserving and improving driving ability by practicing healthy exercise and physical activity among older community members, whose driving abilities are expected to decline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Driving ability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Encourage participation by holding 12 90-minute health exercise classes over 12 weeks.
Interventions/Control_2
No intervention for 12 weeks.
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) hold a regular driver's license
(2) drive a car daily
(3) have recent driving concerns
Key exclusion criteria
(1) Participants needed no doctor-diagnosed exercise contraindications
(2) Independent access to the health class venue
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | akihiko |
| Middle name | |
| Last name | katayama |
Organization
Shikoku Gakuin University
Division name
Faculty of Sociology
Zip code
765-8505
Address
Zentsuji-shi, Kagawa 765-8505, Japan
TEL
0877-62-2111
kata@sg-u.ac.jp
Public contact
Name of contact person
| 1st name | akihiko |
| Middle name | |
| Last name | katayama |
Organization
Shikoku Gakuin University
Division name
Faculty of Sociology
Zip code
765-8505
Address
Zentsuji-shi, Kagawa 765-8505, Japan
TEL
0877-62-2111
Homepage URL
kata@sg-u.ac.jp
Sponsor or person
Institute
Shikoku Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Japan Health Promotion and Fitness Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shikoku Gakuin University
Address
Zentsuji-shi, Kagawa 765-8505, Japan
Tel
0877-62-2111
kata@sg-u.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 | 08 | Month | 22 | 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
68
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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059311
