UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061275 |
|---|---|
| Receipt number | R000070106 |
| Scientific Title | The Effects of Stretching Intervention on Menstrual-Related Symptoms and Autonomic Nervous System Function in Female University Students |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/15 18:36:58 |
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Basic information
Public title
The Effects of Stretching Intervention on Menstrual-Related Symptoms and Autonomic Nervous System Function in Female University Students
Acronym
The Effects of Stretching Intervention on Menstrual-Related Symptoms and Autonomic Nervous System Function in Female University Students
Scientific Title
The Effects of Stretching Intervention on Menstrual-Related Symptoms and Autonomic Nervous System Function in Female University Students
Scientific Title:Acronym
The Effects of Stretching Intervention on Menstrual-Related Symptoms and Autonomic Nervous System Function in Female University Students
Region
| Japan |
Condition
Condition
menstrual-related symptoms
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to objectively evaluate the effects of a 3-week stretching intervention on menstrual-related symptoms and autonomic nervous system function in female university students with menstrual-related symptoms, using a randomized controlled trial design with a waitlist control group
Basic objectives2
Others
Basic objectives -Others
Interventional Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of menstrual-related symptoms assessed by the Japanese version of the Menstrual Distress Questionnaire (MDQ; change from baseline)
Key secondary outcomes
Autonomic nervous system indices (heart rate variability analysis)
High-frequency component (HF)
LF/HF ratio
SDNN, RMSSD, total power
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Education
Interventions/Control_2
Stretching
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who have experienced menstrual-related symptoms (primary dysmenorrhea or premenstrual syndrome) severe enough to interfere with daily life or academic performance during the past few months
Key exclusion criteria
History of serious gynecological diseases
History of spinal surgery
Peripheral vascular disorder of the lower extremities
Collagen disease
Cognitive impairment that prevents accurate responses
Current use of hormonal agents or analgesics that may affect the results
Irregular menstrual cycle
Habitual smoking or regular consumption of stimulant beverages (coffee, tea, alcohol, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Sato |
Organization
Ngano University of Health and Medicine
Division name
Division of Physical Therapy, Department of Rehabilitation
Zip code
3812227
Address
11-1 Imaihara, Kawanakajima-machi, Nagano City, Nagano Prefecture
TEL
0262836111
sato.takaaki@shitoku.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Sato |
Organization
Ngano University of Health and Medicine
Division name
Division of Physical Therapy, Department of Rehabilitation
Zip code
3812227
Address
11-1 Imaihara, Kawanakajima-machi, Nagano City, Nagano Prefecture
TEL
0262836111
Homepage URL
sato.takaaki@shitoku.ac.jp
Sponsor or person
Institute
Ngano University of Health and Medicine
Institute
Department
Personal name
Takaaki Sato
Funding Source
Organization
Ngano University of Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Nagano University of Health and Medicine
Address
11-1 Imaihara, Kawanakajima-machi, Nagano City, Nagano Prefecture
Tel
0262836111
nuhm.kikaku@shitoku.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
長野保健医療大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 15 | 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
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2026 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070106
