UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028911
Receipt number 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 15:17:28

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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 or person

Institute

MINISTRY OF EDUCATION,CULTURE,SPORTS,SCIENCE AND TECHNOLOGYļ½„JAPAN

Institute

Department

Personal name



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

Value
https://center6.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