UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038488
Receipt number R000043859
Scientific Title Influences of physical exercises with consideration to time-of-day on physical traits and functions
Date of disclosure of the study information 2019/11/04
Last modified on 2019/11/04 00:56:28

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Basic information

Public title

Influences of physical exercises with consideration to time-of-day on physical traits and functions

Acronym

Influences of physical exercises with consideration to time-of-day on physical traits and functions

Scientific Title

Influences of physical exercises with consideration to time-of-day on physical traits and functions

Scientific Title:Acronym

Influences of physical exercises with consideration to time-of-day on physical traits and functions

Region

Japan


Condition

Condition

Healthy people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether there is a difference of effects of exercise program combined with cognitive training in morning or afternoon on mental and physical health

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive functions (COGNISTAT) before and after the intervention for a duration of 12 weeks

Key secondary outcomes

Mood (POMS) before and after the intervention for a duration of 12 weeks


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Exercise program combined with cognitive training in the afternoon

Interventions/Control_2

Exercise program combined with cognitive training in the morning

Interventions/Control_3

Waiting-list group

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

40 years-old <=

Age-upper limit

79 years-old >=

Gender

Male and Female

Key inclusion criteria

People who are not applicable to exclusion criteria below

Key exclusion criteria

People who
/experienced heart or cerebral stroke in the past six months
/have active phases of acute liver function disorders or chronic viral hepatitis
/have diabetes and experienced a hypoglycemic attack
/are diagnosed as hypertension and taking hypotensive drugs
/have low cognitive functions due to cerebrovascular or Alzheimer diseases etc.
/have any heart diseases
/acute orthopaedic pain and neurological symptoms
/experienced compression fracture with osteoporosis
/have any disorders or history of those which unable to do exercise
/have electrical or magnetic instrument in a body, such as cochlea implant
/have a magnetic aneurysm clip in a cranium
/have magnetic metal in a body due to surgery
/have claustrophobia

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Kawakami

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

359-1192

Address

2-579-15, Mikajima, Tokorozawa, Saitama

TEL

76-6606

Email

ykawa@waseda.jp


Public contact

Name of contact person

1st name Toru
Middle name
Last name Takahashi

Organization

Waseda University

Division name

Graduate School of Human Science

Zip code

359-1192

Address

2-579-15, Mikajima, Tokorozawa, Saitama

TEL

04-2949-8113

Homepage URL


Email

totakahashi@akane.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency, Cabinet office, Cross-ministerial strategic innovation promotion program

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office of Research Ethics concerning Research with Human Subjects

Address

1-104, Totsuka-machi, Shinjuku-ku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.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

2019 Year 11 Month 04 Day


Related information

URL releasing protocol

NA

Publication of results

Unpublished


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

52

Results

Exercise in the afternoon tended to have broader effects on cognitive functions and moods than that in the morning or control condition.

Results date posted

2019 Year 11 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy older adults

Participant flow

Participants were randomly assigned to three groups. They participated in pre-assessment, intervention, and post-assessment.

Adverse events

Nothing

Outcome measures

Cognitive functions and moods

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 06 Month 15 Day

Date of IRB

2016 Year 03 Month 15 Day

Anticipated trial start date

2016 Year 06 Month 16 Day

Last follow-up date

2016 Year 10 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 04 Day

Last modified on

2019 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043859


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name