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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007498
Receipt No. R000008851
Scientific Title The effects of an exercise program on psychological well-being in postpartum mothers: a randomized controlled trial.
Date of disclosure of the study information 2012/03/14
Last modified on 2012/03/13

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Basic information
Public title The effects of an exercise program on psychological well-being in postpartum mothers: a randomized controlled trial.
Acronym The effects of an exercise program on psychological well-being in postpartum mothers.
Scientific Title The effects of an exercise program on psychological well-being in postpartum mothers: a randomized controlled trial.
Scientific Title:Acronym The effects of an exercise program on psychological well-being in postpartum mothers.
Region
Japan

Condition
Condition Healthy postpartum women
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study aimed to evaluate the effectiveness of a postpartum exercise program on psychological well-being.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Health-related quality of life (QOL) using MOS Short-Form 36-Item Health Survey (SF-36v2)
Key secondary outcomes Rosenberg Self-Esteem Scale (RSES), Edinburgh Postnatal Depression Scale (EPDS) , Subjective Fatigue Symptom scale, sleeping condition, Pregnancy Physical Activity Questionnaire (PPAQ)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise class (weekly exercise of 90 minutes for 4 weeks) at 3 months postpartum
Interventions/Control_2 Usual care
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

Not applicable
Gender Female
Key inclusion criteria Healthy postpartum women
Key exclusion criteria Women with restricted physical activity or suffering from psychiatric disorders.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Haruna
Organization The University of Tokyo
Division name Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo
Division name Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address
TEL
Homepage URL
Email mharuna-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2007 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 13 Day
Last modified on
2012 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008851

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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