UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039735
Receipt number 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 18:32:06

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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 or person

Institute

kharazmi university

Institute

Department

Personal name



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

Value
https://center6.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