UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058986 |
|---|---|
| Receipt number | R000067459 |
| Scientific Title | Study on the Effect of Rest and Exercise on Fatigue Improvement |
| Date of disclosure of the study information | 2025/10/04 |
| Last modified on | 2025/09/04 09:49:18 |
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Basic information
Public title
Fatigue Improvement Effect Study
Acronym
Fatigue Improvement Effect Study
Scientific Title
Study on the Effect of Rest and Exercise on Fatigue Improvement
Scientific Title:Acronym
Fatigue Improvement Effect Study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of combining rest and exercise on fatigue.
Basic objectives2
Others
Basic objectives -Others
The effects of improving fatigue will be compared to the effects of each alone to explore how the combined use of the two interventions to improve fatigue.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of change in subjective fatigue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Additional time in bed: 60 minutes/day for 2 weeks
Interventions/Control_2
Additional light exercise (15 minutes of walking, 15 minutes of exercise): 30 minutes/day for 2 weeks
Interventions/Control_3
Additional Time in Bed: 60 minutes/day and light exercise (15 minutes of walking, 15 minutes of exercise): 30 minutes/day , total: 90 minutes/day for 2 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 20 and 59
2. Person who experience daily fatigue
3. Person who agree to use the wearable device (Fitbit), install the dedicated application on their smartphone, and create a Google account for the test.
Key exclusion criteria
1. Person who currently suffer from chronic diseases (diabetes, hypertension, hyperlipidemia, gout, renal disease, rheumatic or respiratory disease, etc.) and are taking medication (however, users of drugs to suppress allergic symptoms such as allergic rhinitis shall be included in the target population)
2. Person who are unable to participate in the study due to liver, renal, or cardiac disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes mellitus, or other diseases
3. Person diagnosed with insomnia, sleep apnea syndrome, or other sleep disorders
4. Person who have been diagnosed with chronic fatigue syndrome
5. Person who are taking sleeping pills
6. Heavy alcohol drinkers (alcohol equivalent of 60g/day or more: (beer: 3 medium bottles (1.5L), sake: 3 gou (540mL), whiskey: 3 double drinks (180mL), shochu: 1.8 gou (330mL) or more)
7. Person who are currently participating in another human clinical trial, or have participated in a trial of another drug or food within the past month, or will participate in another trial in the future during the period of this study.
8. Person who are currently pregnant or wish to become pregnant during the period of participation in the study.
9. Person with a history or current history of drug dependence or alcohol dependence
10. Person who are planning to travel, go on a business trip, or take a vacation for more than 4 consecutive days during the measurement period.
11. Person who work shifts or night shifts.
12. Person with injuries or pains that affect their ability to walk normally.
13. Person who are anxious about blood collection
14. Person who are scheduled to undergo a major life change during the measurement period, such as entering a higher education, getting a job, or moving to a new place of residence.
15. Person who are otherwise deemed unsuitable for the study by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Human Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Sugitani |
Organization
Kao Corporation
Division name
Human Health Care Products Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
sugitani.kei@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2025 | Year | 10 | Month | 04 | 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 | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067459
