Polycystic Ovary Syndrome
Conditions
Interventions
This is a two-arm randomized controlled clinical trial. Randomization will be conducted with a total of 102 individuals meeting the eligibility criteria. Randomization will be performed in blocks usin
blockrand&apos
package in R software, considering blocks of different sizes. This methodology allows for the estimation of equal group sizes. This is an open-label clinical trial. All volunteers will receive initial
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Women diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Consensus criteria; aged between eighteen and forty years
Exclusion criteria
Exclusion criteria: Women with endocrine system abnormalities that may interfere with the hypothalamic pituitary axis; hyperprolactinemia; thyroid disorders; late-onset congenital adrenal hyperplasia; Cushing’s syndrome; presence of androgen producing ovarian or adrenal tumors; smokers; alcoholics; pregnant; breastfeeding women; those who do not adhere to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find higher adherence and intensity of physical activity in the group receiving the weekly questionnaire via WhatsApp. This will be assessed by self-reported physical activity levels before and after the intervention, and through bioimpedance results at the beginning and end of the 12-week period;It is expected to find lean mass gain, a reduction in body fat percentage, and a reduction in anthropometric measurements in the group receiving weekly questionnaires via WhatsApp. This will be evaluated by comparing bioimpedance results and tape measurements at the beginning and after 12 weeks of the study protocol;To evaluate the effect of regular physical activity on metabolic parameters and insulin sensitivity using biochemical blood assays (glucose by oxidase, insulin by chemiluminescence, and lipid profile by enzymatic method). We will observe fasting glucose levels, total cholesterol, triglycerides, and the calculation of the HOMA-IR index (Homeostasis Model Assessment of Insulin Resistance) | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes | — |
Countries
Brazil
Contacts
Public ContactCarolina Andrade
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed