UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055414 |
|---|---|
| Receipt number | R000063326 |
| Scientific Title | Exploratory Study of Individual Differences in the Effectiveness of Interventions of Fatigue Improvement |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2025/03/06 10:14:17 |
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Basic information
Public title
Fatigue Improvement Intervention Study
Acronym
Fatigue Improvement Intervention Study
Scientific Title
Exploratory Study of Individual Differences in the Effectiveness of Interventions of Fatigue Improvement
Scientific Title:Acronym
Fatigue Improvement Intervention Study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore individual differences in the effects of exercise and rest on the effectiveness of recovery from fatigue.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between the amount of change in waking fatigue before and after the intervention and baseline measurement data.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between the amount of change in waking fatigue before and after the intervention and baseline measurement data
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform light exercise for 30 minutes per day, 5 weekdays (Monday upon waking to Friday upon waking)-Extending the average time in bed by 1.2 times per day for 5 weekdays (from Monday waking time to Friday waking time)
Interventions/Control_2
Extending the average time in bed by 1.2 times per day for 5 weekdays (from Monday waking time to Friday waking time)-Perform light exercise for 30 minutes per day, 5 weekdays (Monday upon waking to Friday upon waking)
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Person between the ages of 20 and 59 years old.
2. Person whose scores on one or more of the five factor scores on the Waking Sleep Sensation Questionnaire is less than 50, which is the average.
3. Person whose work-at-home or work-at-home status does not change more than 2 days per week on average.
4. Person who agrees to use a wearable measurement device.
Key exclusion criteria
1. Person who currently suffers from chronic diseases (diabetes, hypertension, hyperlipidemia, gout, renal disease, rheumatic or respiratory disease, etc.) and are taking medication (however, users of drugs to control allergic symptoms such as allergic rhinitis shall be included in the target population).
2. Person who is unable to participate in the study due to liver, renal, cardiac, respiratory, endocrine, metabolic, neurological, consciousness, diabetes, or other diseases.
3. Patient with insomnia, sleep apnea syndrome, or other sleep disorders.
4. Patient with chronic fatigue syndrome
5. Patient taking sleeping pills
6. Person who drinks a lot of alcohol (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. Patient with skin diseases (atopic dermatitis, acne vulgaris, psoriasis, etc.) on the face.
8. Person who uses topical medical products on the face.
9. Patient with excessive sunburn on the face.
10. Person who is currently participating in other human clinical trials or have participated in other drug or food trials within the past month or are planning to participate in other trials in the future during the period of this study.
11. Person who is not on a day shift, such as night work or rotating shifts.
12. Person who is currently pregnant or wish to become pregnant during the study participation period.
13. Person with a history or current history of drug or alcohol dependence.
14. Person who is planning to travel, go on business, or go on vacation during the measurement period.
15. Person who does not own a smart phone and is unable to complete the questionnaire via an app or web browser.
16. Person who is deemed inappropriate for the study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
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
hibi.masanobu@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
| 2024 | Year | 09 | Month | 17 | 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
91
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063326
