UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055675 |
|---|---|
| Receipt number | R000062019 |
| Scientific Title | Effects of Visual Cognitive and Motor Training with Foot Manipulation on Cognitive and Physical Function in Older Adults |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/30 10:13:31 |
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Basic information
Public title
Effects of Visual Cognitive and Motor Training with Foot Manipulation on Cognitive and Physical Function in Older Adults
Acronym
Effects of Visual Cognitive and Motor Training with Foot Manipulation on Cognitive and Physical Function in Older Adults
Scientific Title
Effects of Visual Cognitive and Motor Training with Foot Manipulation on Cognitive and Physical Function in Older Adults
Scientific Title:Acronym
Effects of Visual Cognitive and Motor Training with Foot Manipulation on Cognitive and Physical Function in Older Adults
Region
| Japan |
Condition
Condition
Healthy elderly people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of seated visual and motor function training conducted through foot manipulation on the integrated cognitive functions and physical abilities of elderly individuals, with the aim of improving their overall cognitive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in physical functions (body composition, agility, muscle strength, balance function, walking ability)
Key secondary outcomes
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Training group: Conduct a 20-minute training session once a week in an exercise class for three months.
Interventions/Control_2
Control group: Participate in measurements at the initial session, after one month, and after three months.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy elderly people
Key exclusion criteria
(1) Users of implanted electrical stimulation devices such as pacemakers
(2) People with disabilities affecting daily living activities
(3) People with severe visual impairments
(4) People with mental illnesses (such as dementia and depression)
(5) People with a history of neurodegenerative diseases (e.g., Parkinson's disease)
(6) People advised by a doctor not to engage in physical activity
(7) People experiencing symptoms such as dizziness, unsteadiness, or general tremors
(8) People with a history of cerebrovascular, cardiovascular, respiratory, or musculoskeletal diseases
(9) People with paralysis or other serious health issues
(10) People with walking disabilities or who require walking aids
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kawagoe |
Organization
Aichi Medical University
Division name
Faculty of Medicine
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
TEL
+81-561-62-3311
kawagoe.t@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kawagoe |
Organization
Aichi Medical University
Division name
Department of Health and Psychosocial Medicine
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
TEL
+81-561-62-3311
Homepage URL
kawagoe.t@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Takashi Kawagoe
Funding Source
Organization
JSPS KAKENHI Grant
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
Aichi Medical University Ethics Committee
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
Tel
0561-62-3311
amu_ethics@aichi-med-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
| 2024 | Year | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062019
