UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055688 |
|---|---|
| Receipt number | R000063637 |
| Scientific Title | Research on adolescent exercise experience and health issues at each stage of a woman's life |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/10/01 13:07:13 |
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Basic information
Public title
Research on adolescent exercise experience and health issues at each stage of a woman's life
Acronym
Exercise experience and women's health issues
Scientific Title
Research on adolescent exercise experience and health issues at each stage of a woman's life
Scientific Title:Acronym
Exercise experience and women's health issues
Region
| Japan |
Condition
Condition
dysmenorrhea
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this study, we will conduct physical, physiological, and biochemical measurements and psychological testing on female athletes who are currently competing and those who have retired, and examine whether or not their experience of exercise during adolescence is related to the onset of women-specific health problems. We also aim to clarify the factors that cause women-specific health problems at each stage of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, muscle mass, estradiol, progesterone, intestinal bacteria, antioxidant capacity, bone mineral density, body sway, jumping, muscle strength
Key secondary outcomes
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Women with athletic experience.
Women with no athletic experience.
Key exclusion criteria
Participants are excluded if they were unable to complete the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Onuma |
Organization
Nihon University
Division name
School of pharmacy
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba, Japan
TEL
047-465-5827
onuma.naoko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Matsuo |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
154-0002
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo
TEL
03-6453-1767
Homepage URL
matsuo.eriko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of pharmacy, Nihon university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University College of Sports Sciences
Address
3-34-1, Shimouma, Setagaya-ku, Tokyo
Tel
03-6453-1600
rmss.kenkyu@nihon-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
日本大学スポーツ科学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | 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
In this study, we will conduct an observational study using the following methods in order to clarify the factors that cause women-specific health problems at each stage of life from a physical perspective, with a focus on exercise experience.
The subjects will be women who have had exercise experience during adolescence and women who have not had exercise experience. No intervention will be conducted for either group, and the same measurements will be taken.
First, as Step 1, the menstrual cycle will be selected. Next, as Step 2, physical measurements will be taken for each cycle. In each cycle determined in Step 1, the items listed in the Outcome Evaluation section will be measured. In addition, a survey of awareness using the Japanese version of the POMS (a scale for evaluating emotions and moods) and the MDQ (a survey of menstrual disorders) will be conducted, as well as a dietary survey using the BDHQ (a brief self-administered diet history questionnaire).
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063637
