UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046115 |
|---|---|
| Receipt number | R000052638 |
| Scientific Title | Study on the effects of exercise programs for postpartum female |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2021/11/18 19:11:30 |
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Basic information
Public title
Study on the effects of exercise programs for postpartum female
Acronym
Study on the effects of exercise programs for postpartum female
Scientific Title
Study on the effects of exercise programs for postpartum female
Scientific Title:Acronym
Study on the effects of exercise programs for postpartum female
Region
| Japan |
Condition
Condition
postpartum female
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of physical exercise for postpartum female
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
leg strength
EPDS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Individual exercise
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
female suffering from healthy during the course of a pregnancy
Key exclusion criteria
hypertensive disorders of pregnancy
diabetes in pregnancy
be scheduled for deliver by Cesarean section
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Sakakibara |
Organization
SAGA UNIVERSITY
Division name
faculty of medicine
Zip code
849-8501
Address
5-1-1 Nabesima, Saga-shi, Saga-ken Japan
TEL
0952-34-2559
sakakiba@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Sakakibara |
Organization
SAGA UNIVERSITY
Division name
faculty of medicine
Zip code
849-8501
Address
5-1-1 Nabesima, Saga-shi, Saga-ken Japan
TEL
0952-34-2559
Homepage URL
sakakiba@cc.saga-u.ac.jp
Sponsor or person
Institute
SAGA UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIATY FOR THE PROMOTION OF SCIENCE
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
SAGA UNIVERSITY
Address
5-1-1 Nabesima, Saga-shi, Saga-ken Japan
Tel
0952-34-2559
sakakiba@cc.saga-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
| 2022 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052638
