UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039628 |
|---|---|
| Receipt number | R000045189 |
| Scientific Title | Effects of enjoyable multi-task exercise on objective sleep quality in older adults |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/10/13 09:23:27 |
* 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
Effects of enjoyable exercise on sleep and cognitive function in older adults
Acronym
Effects of kind of exercise on sleep and cognitive function in older adults
Scientific Title
Effects of enjoyable multi-task exercise on objective sleep quality in older adults
Scientific Title:Acronym
Effects of engaging in enjoyable multi-task exercise on sleep and cognitive function in older adults
Region
| Japan |
Condition
Condition
Older adults (65-79 years)
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of enjoyable multi-task exercise on sleep and cognitive function in older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Polysomnography (sleep architecture)
Stroop test (cognitive function)
Key secondary outcomes
Body core temperature (Rectal temperature)
Metabolism (Total energy expenditrue)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
control- low intensity of exercise(stepping exercise or multi-task exercise)- moderate to vigorous exercise(stepping exercise or multi-task exercise)
Interventions/Control_2
control- moderate to vigorous exercise(stepping exercise or multi-task exercise)- low intensity of exercise(stepping exercise or multi-task exercise)
Interventions/Control_3
low intensity of exercise(stepping exercise or multi-task exercise)- control- moderate to vigorous exercise(stepping exercise or multi-task exercise)
Interventions/Control_4
low intensity of exercise(stepping exercise or multi-task exercise)- moderate to vigorous exercise(stepping exercise or multi-task exercise)-control
Interventions/Control_5
moderate to vigorous exercise(stepping exercise or multi-task exercise)-control- low intensity of exercise(stepping exercise or multi-task exercise)
Interventions/Control_6
moderate to vigorous exercise(stepping exercise or multi-task exercise)- low intensity of exercise(stepping exercise or multi-task exercise)-control
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
Aged 65 to 79 years.
No take sleeping pills.
Free of the medical history of diabetes and respiratory disease(e.g. asthma).
Free of the medical history of sleep apnea.
Who are not prohibited from exercising by a doctor.
Key exclusion criteria
No tendency of cognitive decline(MMSE>27points)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
TEL
029-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jaehoon |
| Middle name | |
| Last name | Seol |
Organization
University of Tsukuba
Division name
Doctoral Program in Physical Education, Health and Sport Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
TEL
029-853-2639
Homepage URL
s1730502@s.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
Tel
029-853-2571
hitorinri@un.tsukuba.ac.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
筑波大学（茨城県）/ University of Tsukuba (Ibaraki, Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | 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
15
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
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045189
