UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059377 |
|---|---|
| Receipt number | R000067892 |
| Scientific Title | Examining the immediate effects of stretching on postpartum mental health. |
| Date of disclosure of the study information | 2025/10/12 |
| Last modified on | 2025/10/12 08:59:24 |
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Basic information
Public title
Examining the immediate effects of stretching on postpartum mental health.
Acronym
Research on the Immediate Effects of Stretching on Postpartum Mental Health
Scientific Title
Examining the immediate effects of stretching on postpartum mental health.
Scientific Title:Acronym
Research on the Immediate Effects of Stretching on Postpartum Mental Health
Region
| Japan |
Condition
Condition
postpartum depression
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the immediate mood-enhancing effects of stretching in postpartum women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Profile of mood state - 2 Adult Short
Key secondary outcomes
A Visual Analogue Scale is used to measure subjective assessments of physical complaints.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
For the stretching intervention, subjects perform a 10-minute static stretching programme. The target areas are primarily the neck, upper limbs, trunk and lower limbs. Video demonstrations are used and subjects are instructed to perform the stretches within a pain-free range while maintaining their breathing. The posture for each stretch and the region being stretched are confirmed, and guidance is provided as needed to correct the position during the exercise.
Interventions/Control_2
The control is supine rest for approximately 10 minutes.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Primiparous or multiparous women who have given birth within the past four months.
Individuals with no medical contraindications to physical exercise.
Key exclusion criteria
Individuals diagnosed with postpartum depression:
Individuals scoring 9 points or higher on the Japanese version of the Edinburgh Postnatal Depression Scale
Individuals currently experiencing orthopedic disorders in the lower limbs or trunk, as well as mental, neurological, or cardiovascular disorders.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Onishi |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
a-planning@jmj.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Onishi |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
izm.0024@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Izumi Onishi
Funding Source
Organization
Tokyo Metropolitan University
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
Research Ethics Committee of Arakawa Campus Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
a-rinri@jmj.tmu.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
東京都立大学荒川キャンパス（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 12 | 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 | 04 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067892
