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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000039112 |
Receipt No. | R000044608 |
Scientific Title | The Beneficial Effects of Eight Weeks Functional Strength and Stabilizing Exercises on Postpartum Pain, Fatigue, performance and Disability |
Date of disclosure of the study information | 2020/04/30 |
Last modified on | 2020/05/04 |
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 |
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Condition | |||
Condition | pre-post intervention | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |