UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038488
Receipt No. 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 (Ver. 1)

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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
Institute Waseda University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043859