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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028911
Receipt No. R000033084
Scientific Title The effect of leg muscle strength training on early postpartum mothers who experienced bedrest during pregnancy.
Date of disclosure of the study information 2017/09/01
Last modified on 2021/03/24

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Basic information
Public title The effect of leg muscle strength training on early postpartum mothers who experienced bedrest during pregnancy.
Acronym The effect of leg muscle strength training on early postpartum mothers who experienced bedrest during pregnancy.
Scientific Title The effect of leg muscle strength training on early postpartum mothers who experienced bedrest during pregnancy.
Scientific Title:Acronym The effect of leg muscle strength training on early postpartum mothers who experienced bedrest during pregnancy.
Region
Japan

Condition
Condition postpartum mother
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to explore the effect of leg muscle strength training on early postpartum mothers who experienced bedrest during pregnancy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes leg muscle strength
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 leg muscle strength trainin
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
50 years-old >
Gender Female
Key inclusion criteria 20 postpartum mothers who experienced bedrest one week or more during pregnancy and 20 postpartum mothers who was in normally progressing during pregnancy.
Key exclusion criteria postpartum mothers who have medical treatment for muscle disease,postpartum mothers who take pill with side effect to reduce muscle,and cesarean section
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazuyo
Middle name
Last name Oishi
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Institute of Biomedical Sciences
Zip code 852-8520
Address 1-7-1 SAKAMOTO NAGASAKI,852-8520 JAPAN
TEL 095-819-7980
Email k-oishi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Kazuyo
Middle name
Last name Oishi
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Institute of Biomedical Sciences
Zip code 852-8520
Address 1-7-1 SAKAMOTO NAGASAKI,852-8520 JAPAN
TEL 095-819-7980
Homepage URL
Email k-oishi@nagasaki-u.ac.jp

Sponsor
Institute MINISTRY OF EDUCATION,CULTURE,SPORTS,SCIENCE AND TECHNOLOGYļ½„JAPAN
Institute
Department

Funding Source
Organization MINISTRY OF EDUCATION,CULTURE,SPORTS,SCIENCE AND TECHNOLOGYļ½„JAPAN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Graduate School of Biomedical Sciences
Address 1-7-1 SAKAMOTO NAGASAKI,852-8520 JAPAN
Tel 095-819-7980
Email k-oishi@nagasaki-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
2017 Year 09 Month 01 Day

Related information
URL releasing protocol http://upload.umin.ac.jp/rd/rd.cgi?t=sa&n=R000033084&k=9007Kk3t0gLIT5Ber7QDjARf
Publication of results Unpublished

Result
URL related to results and publications Masters thesis Nagasaki University Graduate School of Biomedical Sciences 2018 and 2019
Number of participants that the trial has enrolled 15
Results The mean of muscle strength and the mean of body weight ratio on the 1st day
of puerperium and before training on the day of discharge were significantly increased (p <0.001).
In the immediate effect of the training intervention, the mean muscle strength and the
mean weight ratio increased significantly on the discharge date before training and the discharge date after training. It was (p <0.001).
Results date posted
2021 Year 03 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The women who gave birth at University Hospital from September 2017 to November 2018.
Participant flow Fifteen patients who agreed with the study and were able to perform muscle strength measurement and training during puerperal hospitalization were included in the analysis.
Adverse events nothing
Outcome measures The mean of muscle strength and the mean of body weight ratio on the 1st day of puerperium and before training on the day of discharge were significantly increased (p <0.001). In the immediate effect of the training intervention, the mean muscle strength and the mean weight ratio increased significantly on
the discharge date before training and the discharge date after training (p <0.001).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 08 Month 21 Day
Date of IRB
2017 Year 07 Month 21 Day
Anticipated trial start date
2017 Year 09 Month 04 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2021 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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