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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039735
Receipt No. R000045317
Scientific Title The Effects of Eight-Week Functional Strength Training and Stabilizing Exercises on Postpartum Pain, Fatigue, Functional Disability, and performance
Date of disclosure of the study information 2020/03/07
Last modified on 2020/03/07

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Basic information
Public title The Effects of Eight-Week Functional Strength Training and Stabilizing Exercises on Postpartum Pain, Fatigue, Functional Disability, and performance
Acronym The Effects of Eight-Week Functional Strength Training and Stabilizing Exercises on Postpartum Pain, Fatigue, Functional Disability, and performance
Scientific Title The Effects of Eight-Week Functional Strength Training and Stabilizing Exercises on Postpartum Pain, Fatigue, Functional Disability, and performance
Scientific Title:Acronym The Effects of Eight-Week Functional Strength Training and Stabilizing Exercises on Postpartum Pain, Fatigue, Functional Disability, and performance
Region
Asia(except Japan)

Condition
Condition pre-post intervention
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 assess the effects of functional strength exercise (FSE) and stabilizing exercises (SE) on postpartum PGP, functional disability, fatigue, and selective functional movement assessment (SFMA).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes modified fatigue symptoms checklist (MFSC),
selective functional movement assessment (SFMA),
the Oswestry disability index (ODI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 functional strength exercise (FSE)
Interventions/Control_2 stabilizing exercises (SE)
Interventions/Control_3 control
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
45 years-old >=
Gender Female
Key inclusion criteria having PGP, the participants had to have a history of non-traumatic onset of pelvic pain, positive posterior pelvic pain provocation (PPPP or 4P test) and straight leg raise(SLR) test, being within the age range of 20 and 38 years old, body mass index (BMI) not exceeding 30kg/ m2, history of maximum two natural vaginal deliveries
Key exclusion criteria had a history of prenatal and postnatal complications, including abnormal bleeding, hypertension, toxemia, preeclampsia, or high-risk pregnancy, gestational diabetes, any type of cardiopulmonary, neurologic, neuromuscular and chronic kidney disease.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Amir
Middle name
Last name Letafatkar
Organization kharazmi university
Division name department of corrective exercises and sport injuries
Zip code 4352763633
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 009802122258084
Email letafatkaramir@yahoo.com

Public contact
Name of contact person
1st name Amir
Middle name
Last name letafatkar
Organization kharazmi University
Division name department of biomechanics and sport injuries
Zip code 4353663663
Address tehran-mirdamad-sout razan street, faculty of PE
TEL 00989195394692
Homepage URL
Email letafatkaramir@yahoo.com

Sponsor
Institute kharazmi university
Institute
Department

Funding Source
Organization self funding
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 kharazmi university
Address gisha bridge, jalal aleahmad , kharazmi university,tehran
Tel 982182883595
Email healthcontrol@kharazmi.ac.ir

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
2020 Year 03 Month 07 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 60
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
2019 Year 02 Month 05 Day
Date of IRB
2019 Year 03 Month 07 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2019 Year 07 Month 13 Day
Date of closure to data entry
2019 Year 09 Month 07 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 07 Day
Last modified on
2020 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045317

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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