UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058231 |
|---|---|
| Receipt number | R000063419 |
| Scientific Title | The effects of the home-based exercise program on sleep status. |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/06/20 10:36:50 |
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Basic information
Public title
The effects of the home-based exercise program on sleep status.
Acronym
The effects of the home-based exercise program on sleep status.
Scientific Title
The effects of the home-based exercise program on sleep status.
Scientific Title:Acronym
The effects of the home-based exercise program on sleep status.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of home-based exercise intervention among middle-aged Japanese adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Sleep status
Key secondary outcomes
Physical activity
Sedentary behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise intervention for 4 weeks and home-based exercise for 12 weeks.
Interventions/Control_2
No treatment.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 30 to 59 years.
Japanese men and women.
Key exclusion criteria
Participation in other intervention.
Coronary disease.
Mental disorder.
Contraindication of exercise at a physician's direction.
Shift work, late-night work, or long business trips, during the study period.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kyohsuke |
| Middle name | |
| Last name | Wakaba |
Organization
Jumonji University
Division name
Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama
TEL
048-260-7692
k-wakaba@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyohsuke |
| Middle name | |
| Last name | Wakaba |
Organization
Jumonji University
Division name
Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama
TEL
048-260-7692
Homepage URL
k-wakaba@jumonji-u.ac.jp
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
Kyohsuke Wakaba
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jumonji University
Address
2-1-28 Sugasawa, Niiza, Saitama
Tel
048-477-0555
k-kenkyu@jumonji-u.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
十文字学園女子大学（埼玉県）、和光市中央公民館（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 30 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063419
