UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034003
Receipt number R000038774
Scientific Title Effect of home exercise program on the cognitive function of community dwelling elderly people
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/03 12:44:38

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Basic information

Public title

Effect of home exercise program on the cognitive function of community dwelling elderly people

Acronym

Home exercise program for the cognitive function

Scientific Title

Effect of home exercise program on the cognitive function of community dwelling elderly people

Scientific Title:Acronym

Home exercise program for the cognitive function

Region

Japan


Condition

Condition

community dwelling elderly people

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is evaluating the effect of a home exercise program on cognitive function in community dwelling elderly people.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effect on cognitive function for baseline, 3-months, 6-months and a further period.

Key secondary outcomes

motor function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Self exercise training with cognitive task at home

Interventions/Control_2

Self exercise training without cognitive task

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Living independently in community
Agreeing with this study

Key exclusion criteria

Nursing care is necessary for living life
Disagreeing with this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohei Maruya

Organization

Saitama medical university

Division name

Department of physical therapy, faculty of medical care

Zip code


Address

Kawakado 981, Moroyama-town, Saitama prefecture

TEL

049-295-1001

Email

maruya@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kohei Maruya

Organization

Saitama medical university

Division name

Department of physical therapy, faculty of medical care

Zip code


Address

Kawakado 981, Moroyama-town, Saitama prefecture

TEL

049-295-1001

Homepage URL


Email

maruya@saitama-med.ac.jp


Sponsor or person

Institute

Saitama medical university

Institute

Department

Personal name



Funding Source

Organization

Saitama medical 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

2018 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

2018 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 20 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

2018 Year 09 Month 03 Day

Last modified on

2018 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038774


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name