Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000283976
Ethics application status
Approved
Date submitted
14/02/2011
Date registered
17/03/2011
Date last updated
17/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of the effectiveness of the pilates method on stress urinary incontinence
Scientific title
Analysis of the effectiveness of the pilates method on stress urinary incontinence
Secondary ID [1] 253600 0
There's no other number
Universal Trial Number (UTN)
U1111-1119-4438
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 261160 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259314 259314 0 0
Physiotherapy
Musculoskeletal 259358 259358 0 0
Other muscular and skeletal disorders
Renal and Urogenital 259377 259377 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
kinesiotherapy
Exercise 1 - Patient will begin with 5 minutes of global stretching of the upper and lower limb.
Exercise 2 - The patient will sit on the ball (Bobath) will be held and mobility pelvic movements (exercises anteversion / retroversion, lateral inclination).
Exercise 3 - Hundred (Hundred) - Starting Position: Patient supine, hip and knee flexed 90 degress, the scapula stabilized, arms at your sides and palms facing down. Exercise: patient inhales, the expiration patient flex the head and upper body, stabilizing the shoulder blades and tightening the abdominal muscles and the perineum ("Hold Your Wee") and extend the knees. Inspiring, returning to its initial position.
Exercise 4 - Double leg stretch (Double Leg Stretch) - Starting Position: Patient supine, hip and knee flexed at 90 degrees, bring your hands on your ankles. Will flex the trunk and maintaining the elongated head and feet in tip. Exercise: A patient inspires, the patient expired contract the abdomen and the perineum muscle and spreading her legs and arms outstretched to take the head. Inspiring, returning to its initial position
Exercise 5 - Bearing partial back (Half roll back) - Starting Position: Patient seated, knees bent, feet parallel, about the column bent knees, arms extended and stabilized scapula. Exercise: A patient inspires, the patient expired contracts abdomen and perineum muscle and starts rolling back and can continue while maintaining lumbar flexion and feet on the mat. Inhale, returning to its initial position.
Exercise 6 - Preparing for the bridge (Shoulder Bridge Prep) - Starting Position: Patient supine, knees bent and parallel to the line of hip, scapula stabilized, arms at your sides and palms facing down. Exercise: A patient inspires, the patient expired contracts abdomen and perineum muscle, lift your pelvis up vertebra by vertebra, extending the column. Inhale, returning to its initial position.
Exercise 7 - Kick Series IV (Side Kick Series IV) - Starting position: lying on its side on the outstretched arm (serving as the headrest), neutral spine and pelvis, scapula stabilized, and one arm resting on the mat. Top leg bent forward with the other foot and lower leg perform adduction, standing on tip. Exercise: inspiration, during expiration the patient contracts the abdominal muscles and perineum, leading to the leg from the bottom up (adduction), inhale back to the starting position.
Exercise 8 - Coordination (Coordination) - Starting Position: Patient supine, hip flexed at 45 degrees, the scapula stabilized, arms above your head holding the ball Bobath. Exercise: inspiration, during expiration the patient will contract the abdomen and perineum muscle, flexing the hip and take the ball to the ankle, holding the ball with the medial malleolus. Inhale back to center position.
Exercise 9 - Circle of the hip (Hip Circles) - starting position: The patient sits on the buttocks, arms extended and resting on the floor, bend the trunk and then bend your legs at 90 degrees to the trunk.
Exercise: Breathe in, hold on expiration circles with the legs.
Exercise 10 - Corkscrew (Corkscrew)
Starting Position: Patient supine, hip flexed at 45 degrees, the scapula stabilized, arms along the body. Exercise: inspiration, during expiration the patient contracts the abdominal muscles and the perineum, held circular motion with both legs at the same time.
All exercises were performed individually by the same physiotherapist three times a week (Monday, Wednesday and Friday), with 1 hour per session for 3 months. All exercises are performed with 10 repetitions of each exercise lasting 1 hour
Intervention code [1] 258021 0
Treatment: Other
Comparator / control treatment
Compared before and after treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262118 0
Urogynecological assessment
Timepoint [1] 262118 0
Urogynecology evaluation contained the data: age, chief complaint, disease history and physical examination. Physical examination was used vaginal cones to determine the degree of perineal muscle strength. The vaginal cones are used in number of five weighing 25g to 65g. The cone weighed a 25g, 35g cone weighing two, three cone weighed 45g, four cone weighed 55g; Cone five weighed 65g.
Procedure:
To determine the degree of muscle strength of the perineum, the patient was instructed to enter each cone in the canal, one at a time and perform 10 steps, and perform 10 squat jumps 10 times and that this cone was inserted into the vagina could not out, indicating that the patient can sustain the cone with the muscles of the perineum. The procedure started with 25gr cone, then get up to 35g to 65g cone.
For the degree of muscle strength "0" indicates that the patient could not sustain the cone 25g
For the degree of muscle strength "1" indicates that the patient could sustain the cone 25g
For the degree of muscle strength "2" indicates that the patient could sustain the cone 35g
For the degree of muscle strength "3" indicates that the patient could sustain the cone 45g
For the degree of muscle strength "4" indicates that the patient could sustain the cone 55g
For the degree of muscle strength "5" indicates that the patient could sustain the cone 65g
The evaluation was performed in the pre-treatment and three months after treatment.
Secondary outcome [1] 273195 0
The Assessment Questionnaire Quality of Life "King's Health Questionnaire (KHQ)
Timepoint [1] 273195 0
King's Health Questionnaire (KHQ) is composed of 21 questions divided into eight areas:
1 - perception generates health,
2 - impact of urinary incontinence,
3 - limitations of daily activities,
4 - physical limitations,
5 - social limitations,
6 - personal relationships,
7 - emotions,
8 - sleep / disposal. Each response is referred to a value (0 = no / not sure; 1 = little / rarely, 2 = average / sometimes, 3 = very much / always).
Scores range from 0 to 100 and the higher the score, the greater the impact on quality of life
Was assessed at pre-treatment and three months after treatment

Eligibility
Key inclusion criteria
included in the study a female patient aged 47 years with a clinical diagnosis of stress urinary incontinence and physical therapy for pelvic floor muscle weakness with power equal to and above 3.
Minimum age
40 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with urgent urinary incontinence, stress urinary incontinence due to insufficiency insfecteriana, incontinent women, patients with cognitive and neurological injuries that deny patients sign an informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1
Accrual to date
Final
Recruitment outside Australia
Country [1] 3194 0
Brazil
State/province [1] 3194 0
MG
Country [2] 3195 0
Brazil
State/province [2] 3195 0
Pouso Alegre

Funding & Sponsors
Funding source category [1] 258491 0
University
Name [1] 258491 0
University Vale to sapucai
Country [1] 258491 0
Brazil
Funding source category [2] 258495 0
University
Name [2] 258495 0
University Vale to Sapucai
Country [2] 258495 0
Brazil
Primary sponsor type
Individual
Name
Andreia Maria Silva
Address
R Benjamin Constant 93
City: Alfenas
State: MG
CEP: 37130-000
Country
Brazil
Secondary sponsor category [1] 257631 0
None
Name [1] 257631 0
Address [1] 257631 0
Country [1] 257631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260464 0
Ethics Committee in Research UNIVAS
Ethics committee address [1] 260464 0
Ethics committee country [1] 260464 0
Brazil
Date submitted for ethics approval [1] 260464 0
09/08/2010
Approval date [1] 260464 0
09/09/2010
Ethics approval number [1] 260464 0
1482/2010

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

Contacts
Principal investigator
Name 32208 0
Address 32208 0
Country 32208 0
Phone 32208 0
Fax 32208 0
Email 32208 0
Contact person for public queries
Name 15455 0
Andreia Maria Silva
Address 15455 0
R Benjamin Constant 93
City: Alfenas
State: MG
CEP: 37130-000
Country 15455 0
Brazil
Phone 15455 0
55(35)3291-1486
Fax 15455 0
Email 15455 0
[email protected]
Contact person for scientific queries
Name 6383 0
Andreia Maria Silva
Address 6383 0
R Benjamin Constant 93
City: Alfenas
State: MG
CEP: 37130-000
Country 6383 0
Brazil
Phone 6383 0
55(35)3291-1486
Fax 6383 0
Email 6383 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.