UMIN-CTR Clinical Trial

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

Condition
Condition	pre-post intervention
Classification by specialty	Medicine in general 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 04 Month 30 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	Completed
Date of protocol fixation	2020 Year 01 Month 09 Day
Date of IRB	2020 Year 01 Month 11 Day
Anticipated trial start date	2020 Year 02 Month 25 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 10 Day
Last modified on	2020 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044608

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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