UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030057 |
|---|---|
| Receipt number | R000034315 |
| Scientific Title | Cognitive and Physical change by intervention of activity program for elderly |
| Date of disclosure of the study information | 2017/11/21 |
| Last modified on | 2023/08/02 22:38:00 |
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Basic information
Public title
Cognitive and Physical change by intervention of activity program for elderly
Acronym
Cognitive and Physical change by intervention of activity program for elderly
Scientific Title
Cognitive and Physical change by intervention of activity program for elderly
Scientific Title:Acronym
Cognitive and Physical change by intervention of activity program for elderly
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of emotional and cognitive change by activity program for healthy elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive function
mood, motivation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A program combining the cognitive function and the motor function is performed by an actual program condition.
Interventions/Control_2
A program combining the cognitive function and the motor function is performed by a recording program condition.
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
Subjects who can come to Myodani campus
Subjects who can communicate in languagey
Key exclusion criteria
Subjects with disabilities in limbs
Subjects who are wearing electronic devices such as pacemakers
As for the cognitive function measurement program, subjects with MMSE score less than 24
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hayashi |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL
078-792-2555
a-hayashi@pearl.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Hayashi |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL
078-792-2555
Homepage URL
a-hayashi@pearl.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
Kobe University
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
Tel
078-796-4565
a-hayashi@pearl.kobe-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
| 2017 | Year | 11 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2024 | 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
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034315
