Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
REBEC |
Last refreshed on:
|
29 May 2023 |
Main ID: |
RBR-95xdzh |
Date of registration:
|
13/07/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effect of Pilates exercises on glycemic indexes, urinary and sexual symptoms, mobility and quality of life of women with gestational diabetes mellitus
|
Scientific title:
|
Effect of Pilates exercises on glycemic indexes, urinary and sexual symptoms, mobility and quality of life of women with gestational diabetes mellitus |
Date of first enrolment:
|
02/06/2017 |
Target sample size:
|
|
Recruitment status: |
Recruiting |
URL:
|
http://ensaiosclinicos.gov.br/rg/RBR-95xdzh |
Study type:
|
Intervention |
Study design:
|
Clinical trial of treatment, parallel, open, randomized controlled with two arms
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Brazil
| | | | | | | |
Contacts
|
Name:
|
Ana Beatriz Gomes de Souza
Pegorare |
Address:
|
Av. Costa e Silva, s/n - Cidade Universitária
79070-900
Campo Grande
Brazil |
Telephone:
|
+55 (67)33457836 |
Email:
|
anabegs@gmail.com |
Affiliation:
|
Universidade Federal de Mato Grosso do Sul |
|
Name:
|
Ana Beatriz Gomes de Souza
Pegorare |
Address:
|
Av. Costa e Silva, s/n - Cidade Universitária
79070-900
Campo Grande
Brazil |
Telephone:
|
+55 (67)33457836 |
Email:
|
anabegs@gmail.com |
Affiliation:
|
Universidade Federal de Mato Grosso do Sul |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Age above 18 years; literate; with clinical and laboratory diagnosis of gestational diabetes mellitus; with gestational age between 12 and 30 weeks; BMI = 45; sedentary; non-smokers; clinically stable;released by the physician to perform physical activities
Exclusion criteria: Pregnant women with neurological impairment; Endocrine and metabolic complications
Due to DMG; obstetric complications such as systemic arterial hypertension, placenta previa, among others; Presenting pre-existing diabetes (type 1 or 2); heart disease; non-attendance at evaluation; Have more than 25% of absences to the treatment.
Age minimum:
18Y
Age maximum:
45Y
Gender:
F
|
Health Condition(s) or Problem(s) studied
|
C13.703.170
|
Gestational Diabetes Mellitus
|
Intervention(s)
|
Behavioural
|
Procedure/surgery
|
E10-E14
|
C13.703.170
|
Randomized clinical trial of 34 pregnant women with gestational diabetes mellitus divided into 2 groups with 17 pregnant women each Where G1- 17 pregnant women underwent a protocol of pilates exercises twice a week accompanied by conventional treatment and G2 17 pregnant women undergoing conventional treatment only. Individuals will be assessed before and after the 10-week period. Individuals will be evaluated before and after the intervention program, with respect to the demographic data, physical examination (BMI, Blood Pressure, weight gain, instruments of evaluation of sexual function-FSFI questionnaire, urinary symptoms questionnaire (ICIQ-SF), Fasting and postprandial glycemic indexes, mobility (IMG-gestational mobility index), musculoskeletal symptoms questionnaire (Nordic), hospital scale of anxiety and HAD depression, self-esteem questionnaire, and SF-36 quality of life questionnaire.
|
Primary Outcome(s)
|
We expect that pregnant underwent to physical exercises show a impairment of 30% about capilar glicemia, urinary ande sexual funcions and 30% improvement of mobility and quality of life compared to sedentary pregnants.
|
Secondary Outcome(s)
|
There is hope for benefits for all women involved in the study because all of them will be under medical and nutritional treatment, as well as health education.
|
Source(s) of Monetary Support
|
Universidade Federal de Mato Grosso do Sul
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|