UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051458 |
|---|---|
| Receipt number | R000058695 |
| Scientific Title | Effects of transient mild exercise on sleep quality in female college students. |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2023/12/27 11:50:27 |
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Basic information
Public title
Effects of transient mild exercise on sleep quality in female college students.
Acronym
Effects of transient mild exercise on sleep quality.
Scientific Title
Effects of transient mild exercise on sleep quality in female college students.
Scientific Title:Acronym
Effects of transient mild exercise on sleep quality.
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to determine whether female college students with low exercise habits can ensure good sleep quality through mild aerobic exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation of sleep quality through mild exercise implementation (questionnaire survey) and objective evaluation (sleep recording with smart band)
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise includes one set of 30 minutes of step exercise and 10 minutes of jogging.
Interventions/Control_2
No exercise group
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
Female college students without exercise habits
Key exclusion criteria
Female college students who are taking medication for chronic illnesses or who are physically unable to move for any reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences, Department of Food and Health Sciences
Zip code
813-8529
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
TEL
+81-92-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences, Department of Food and Health Sciences
Zip code
813-8529
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
TEL
+81-92-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's University
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
Ethical Committee of Fukuoka Women's University
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
Tel
+81-92-661-2411
soumu@fwu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
The scores for the OSA sleep survey factors of "sleepiness on waking" (p=0.001), "falling asleep and staying asleep" (p=0.022), and "recovery from fatigue" (p=0.033) were significantly higher on the exercise days than on the non-intervention days. The scores for the "sleep duration" factor tended to be higher on the exercise day (p=0.066), and the number of awakenings tended to be lower on the exercise day (p=0.083).
Results date posted
| 2023 | Year | 12 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Dissertations are in progress.
Date of the first journal publication of results
Baseline Characteristics
Female university students without exercise habits
Participant flow
Cross-over trial
Adverse events
none
Outcome measures
OSA Sleep Survey
Sleep latency, number of awakenings
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058695
