UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030057
Receipt No. 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 2018/08/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Atsuko Hayashi
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code
Address 7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL 078-792-2555
Email a-hayashi@pearl.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Hayashi
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code
Address 7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL 078-792-2555
Homepage URL
Email a-hayashi@pearl.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 22 Day
Last follow-up date
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
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.