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
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
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
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
