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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
