Tokyo, Oct. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058986) titled 'Fatigue Improvement Effect Study' on Oct. 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect of combining rest and exercise on fatigue.
Basic objectives2 - Others
Intervention:
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
Eligibility:
Age-lower limit - 20
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 Size - 150
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067459
Disclaimer: Curated by HT Syndication.
