UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012927
Receipt number R000015118
Scientific Title Effect of water based exercise on the cognitive function in independent elderly adults
Date of disclosure of the study information 2014/01/23
Last modified on 2014/01/27 07:44:37

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Basic information

Public title

Effect of water based exercise on the cognitive function in independent elderly adults

Acronym

water based exercise and cognitive function

Scientific Title

Effect of water based exercise on the cognitive function in independent elderly adults

Scientific Title:Acronym

water based exercise and cognitive function

Region

Japan


Condition

Condition

healthy elderly adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to compare the effects of water-based exercise with and without cognitive stimuli on cognitive and physical functions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

cognitive function

Key secondary outcomes

physical function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

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

cognitive water based exercise

Interventions/Control_2

normal water based exercise

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

aged 65 years or more
no cognitive impairment precluding the understanding of the written informed consent document
complete the exercises without nursing assistance

Key exclusion criteria

perform regular exercise outside this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name sato daisuke

Organization

niigata university of health and welfare

Division name

Institute for Human Movement and Medical Sciences

Zip code


Address

shimami-cho 1398, kita-ku, niigata city, niigata

TEL

025-257-4624

Email

daisuke@nuhw.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name sato daisuke

Organization

niigata university of health and welfare

Division name

Institute for Human Movement and Medical Sciences

Zip code


Address

shimami-cho 1398, kita-ku, niigata city, niigata

TEL

025-257-4624

Homepage URL


Email

daisuke@nuhw.ac.jp


Sponsor or person

Institute

niigata university of health and welfare

Institute

Department

Personal name



Funding Source

Organization

niigata university of health and welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

university of tsukuba

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

2014 Year 01 Month 23 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

Completed

Date of protocol fixation

2013 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 15 Day

Last follow-up date

2014 Year 01 Month 27 Day

Date of closure to data entry

2014 Year 01 Month 27 Day

Date trial data considered complete

2014 Year 01 Month 27 Day

Date analysis concluded

2014 Year 01 Month 27 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 23 Day

Last modified on

2014 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015118


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name