UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058630 |
|---|---|
| Receipt number | R000066906 |
| Scientific Title | A Study on Daily Fluctuations in Physical Condition in Young Adult Women |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 11:41:01 |
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Basic information
Public title
A Study on Daily Fluctuations in Physical Condition in Young Adult Women
Acronym
A Study on Daily Fluctuations in Physical Condition in Young Adult Women
Scientific Title
A Study on Daily Fluctuations in Physical Condition in Young Adult Women
Scientific Title:Acronym
A Study on Daily Fluctuations in Physical Condition in Young Adult Women
Region
| Japan |
Condition
Condition
young healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the fluctuation patterns of subjective physical condition over a 30-day period in young healthy adult women
Basic objectives2
Others
Basic objectives -Others
This study aims to explore its associations with potential influencing factors such as menstrual cycle, sleep, physical activity, muscle strength, and vital signs.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Fatigue Symptoms Scale for Youth (SFS-Y)
Key secondary outcomes
sleep quality and sleep duration
physical activity level
muscle strength
heart rate
blood pressure
basal body temperature
menstrual cycle
menstruation-related symptoms
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1.Individuals aged 18 years or older and under 40 years, with no health problems.
2.Individuals who have received a full explanation of the study, sufficiently understood the contents, and voluntarily provided informed consent to participate.
Key exclusion criteria
1.Individuals with any current medical conditions under treatment.
2.Individuals who regularly take medications or supplements that may affect sleep or muscle strength.
3.Individuals receiving treatment for severe menstrual irregularities or secondary amenorrhea.
4.Any other individuals deemed inappropriate as study participants by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1310
as-51@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health Sciences University of Hokkaido
Division name
Department of Physical Therapy, School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133-23-1310
Homepage URL
as-51@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Funding Source
Organization
Health Sciences University of Hokkaido
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
the Ethics Committee of School of Rehabilitaion Sciences, Health Sciences University of Hokkaido
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
Tel
0133-23-1211
kyo-reha@hoku-iryo-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items will be recorded and measured continuously over a 30-day period during daily life
1.Subjective physical condition: Self-recorded each morning using a questionnaire and the Subjective Fatigue Symptoms Scale for Youth (SFS-Y).
2.Sleep duration: Sleep quality and sleep duration will be recorded using an accelerometer-equipped wearable device.
3.Physical activity level: Measured using the same accelerometer-equipped wearable device.
4.Muscle strength: Measured each morning using a handgrip dynamometer.
5.Vital signs: Heart rate and blood pressure will be measured each morning using appropriate measuring devices.
6.Basal body temperature: Measured every morning using a basal thermometer
7.Menstrual record: Self-recorded every morning, including the presence or absence of menstrual-related symptoms
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066906
