Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000598280
Ethics application status
Approved
Date submitted
15/07/2009
Date registered
20/07/2009
Date last updated
20/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
perineal kinesiotherapy on multiparous women with deficiency on muscle strength of pelvic floor
Scientific title
A protocol of exercises to strengthen the perineal muscles of multiparous women with deficiency on muscle strength, determining the minimum number of attendances needed to increase the muscle strength.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiparous women 237252 0
women with deficiency on muscle strength of pelvic floor 237253 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239572 239572 0 0
Physiotherapy
Renal and Urogenital 239573 239573 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical Therapy to pelvic floor, with exercises to strength the perineal muscles in different positions: lying, sitting and standing. The women were submitted to twenty sessions of 40 minutes duration each, twice a week for a total of twentysessions.
Intervention code [1] 236939 0
Rehabilitation
Comparator / control treatment
one group with a protocol with pelvic's floor physical therapy with a physical therapist and other group with perineal exercises during their activities at home. These exercises at home were done twice a week during twenty minutes for a total of eleven weeks. The participants were instructed to clench their buttocks, contractig their pelvic muscles on standing position when they were washing their cloths, when they were squated to sweep the floor and when they were sitting with their backs comfortably. in all this positions they were instructed to count of three and repeat the exercise ten times, for a total of twenty minutes including all the exercises.
Control group
Active

Outcomes
Primary outcome [1] 238365 0
muscle strength of pelvic floor. The muscle strength were evaluated by the vaginal touch. This evaluation were performed by physical touch from the investigator.
Timepoint [1] 238365 0
after a physical therapy protocol
Secondary outcome [1] 244806 0
the minumum number of attended sessions to increase the strength on pelvic floor mucles. The number minimum means that the muscle of pelvic floor could be increase after ten, fifteen or twenty attendings, because the evaluation were done after ten, fifteen and twelve sessions, by the vaginal touch. The pelvic fllor muscles were evaluated by physical touch from the investigator.
Timepoint [1] 244806 0
after ten, fifteen and twenty sessions.

Eligibility
Key inclusion criteria
women with had one or more pregnancy, with one or more offspring on birth, with deficiency on strength of pelvic floor by the vaginal examination.
Minimum age
35 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women submitted to bladder surgery or histerectomy, with body mass index over 30, women with diabetes, hipertension,heart diseases, neurologic diseases, pain and difficulty on move arms and legs; urinary incontinence, pelvic pain, women submitted erlier a physical therapy to strength pelvic floor.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the allocation were done by a sealed opaque envelop
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using table from women who had been stayed on the hospital where the study have been developed. those women will be randomized by an alleatory chance
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
249
Accrual to date
Final
Recruitment outside Australia
Country [1] 1882 0
Brazil
State/province [1] 1882 0
Maranhao/ Sao Luis
Country [2] 1883 0
Brazil
State/province [2] 1883 0
Maranhao

Funding & Sponsors
Funding source category [1] 237329 0
Self funded/Unfunded
Name [1] 237329 0
Country [1] 237329 0
Brazil
Primary sponsor type
Individual
Name
Thaiana Bezerra Duarte
Address
Praca Goncalves Dias, number 21, 2 andar - Centro
CEP: 65025-240
Sao Luis- MA- Brazil
Country
Brazil
Secondary sponsor category [1] 236815 0
None
Name [1] 236815 0
Address [1] 236815 0
Country [1] 236815 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239435 0
Ethics Committee of Research of University Hospital of Federal University of Maranhao
Ethics committee address [1] 239435 0
Ethics committee country [1] 239435 0
Brazil
Date submitted for ethics approval [1] 239435 0
07/12/2006
Approval date [1] 239435 0
19/01/2007
Ethics approval number [1] 239435 0
1/07/0002

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29899 0
Address 29899 0
Country 29899 0
Phone 29899 0
Fax 29899 0
Email 29899 0
Contact person for public queries
Name 13146 0
Maria Bethenia da Costa Chein
Address 13146 0
Praca Goncalves Dias, number 21- 2 Andar
Centro. Sao Luis- Maranhao
CEP: 65025-240
Country 13146 0
Brazil
Phone 13146 0
55 31 98 3232-0286
Fax 13146 0
55 31 98 3232-0286
Email 13146 0
[email protected]
Contact person for scientific queries
Name 4074 0
Thaiana Bezerra Duarte
Address 4074 0
Praca Goncalves Dias, number 21- 2nd Andar
Centro Sao Luis- Maranhao
CEP: 65025-240
Country 4074 0
Brazil
Phone 4074 0
55 31 98 3232-0286
Fax 4074 0
55 31 98 3232-0286
Email 4074 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.