UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040150 |
|---|---|
| Receipt number | R000045217 |
| Scientific Title | Effects of different of exercise intensity engaging in the evening on sleep in older adults with insomnia. |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2021/10/13 09:25:36 |
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Basic information
Public title
Effects of different of exercise intensity engaging in the evening on sleep in older adults.
Acronym
Effects of different of exercise intensity on sleep in older adults.
Scientific Title
Effects of different of exercise intensity engaging in the evening on sleep in older adults with insomnia.
Scientific Title:Acronym
Effects of exercise intensity engaging in the evening on sleep in older adults with insomnia.
Region
| Japan |
Condition
Condition
Older adults (65-79 years)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of different of exercise intensity in the evening on sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Objective sleep parameters (actigraph)
Subjective sleep parameters (questionnaire, sleep dairy) on during the intervention period
Key secondary outcomes
Intensity of physical activity on during the intervention period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In evening (after pm18:00), about 30 minutes of low-intensity exercise for twelve weeks.
Interventions/Control_2
In evening (after pm18:00), about 30 minutes of moderate to vigorous intensity exercise for twelve weeks.
Interventions/Control_3
No interventional for twelve weeks.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 65 to 79 years.
Who are not prohibited from exercising by a doctor.
No take sleeping pills.
Free of medical history of sleep apnea syndrome.
No clinical research participation over the past year.
Free of medical history of diabetes.
Habitual Exercise less than 2 times in week.
Key exclusion criteria
Who certified as long-term care insurance.
Free of medical history of serious disease, cerebrovascular disease and paralysis.
Total score of PSQI 5<=
Target sample size
60
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
305-8574
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
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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 | 06 | Month | 10 | 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
60
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 | 10 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | 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 | 04 | Month | 13 | 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=R000045217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
