UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031369 |
|---|---|
| Receipt number | R000035804 |
| Scientific Title | The change of physical strength during pregnancy and postpartum |
| Date of disclosure of the study information | 2018/02/24 |
| Last modified on | 2018/02/19 15:20:13 |
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Basic information
Public title
The change of physical strength during pregnancy and postpartum
Acronym
The change of physical strength during pregnancy and postpartum
Scientific Title
The change of physical strength during pregnancy and postpartum
Scientific Title:Acronym
The change of physical strength during pregnancy and postpartum
Region
| Japan |
Condition
Condition
healthy pregnant and postpartum women (within a year after childbirth)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify changes in physical strength associated with pregnancy and its recovery process
Basic objectives2
Others
Basic objectives -Others
Assessment of physical strength
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength of pregnant and postpartum women (within a year after childbirth)
Key secondary outcomes
balance ability, physical activity
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
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant or postpartum women (within a year after childbirth)
Key exclusion criteria
The patient who has central nervous system or musculoskeletal disease
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kajiwara Yu |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
y.kajiwara@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kajiwara Yu |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
y.kajiwara@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Address
Tel
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
| 2018 | Year | 02 | Month | 24 | 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
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design: cross-sectional study
subject: participants who come to health promotion events and agree with attention to this study
assessment: grip strength, grip strength of foot, functional reach test, IPAQ Japanese version, locomotive syndrome check test, demographic data,
Management information
Registered date
| 2018 | Year | 02 | Month | 19 | Day |
Last modified on
| 2018 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035804
