UMIN-CTR Clinical Trial

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
Email	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
Email	sakakiba@cc.saga-u.ac.jp

Sponsor
Institute	SAGA UNIVERSITY
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052638