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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name