Study design, materials and methods
This was a randomized, controlled, parallel, single-blind clinical trial including 40 pregnant women aged 18–45 years with GDM. Participants were allocated to an Exercise Group (EG; n = 20) or Control Group (CG; n = 20). Sample size was calculated using G*Power (significance level of 0.05, 80% power, two groups and time points, and an effect size of 0.23). The study was approved by an institutional ethics committee, and all participants provided written informed consent.
The EG followed a semi-supervised exercise program (aerobic training, global strengthening, and pelvic floor muscle training) for 10–20 weeks, depending on gestational age at recruitment, with telemonitoring via smartphone. The CG received an educational booklet over the same period.
Clinical, sociodemographic, and obstetric data were collected at baseline and follow-up. Urinary symptoms were assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and the urinary subscales of the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7), namely the Urinary Distress Inventory (UDI-6) and Urinary Impact Questionnaire (UIQ-7). At the end of the study, the Patient Global Impression of Change (PGI-C) was also assessed.
The intervention lasted from 10 to 20 weeks, according to gestational age at recruitment (14–25 weeks), up to 36 weeks of gestation. Data were analyzed using Generalized Estimating Equations, considering group, time, and the group × time interaction. Stratified analyses were performed according to the presence of urinary incontinence (UI), with significance set at p < 0.05.
Results
Participants had a mean age of 32.5 ± 5.4 years in the EG and 28.4 ± 6.2 years in the CG, with a mean pre-pregnancy body mass index (BMI) of 20.6 ± 4.6 kg/m² and 29.8 ± 7.6 kg/m², respectively. Most participants had ≥2 pregnancies (80% in the EG vs. 65% in the CG), and the majority had a previous history of GDM (95% in both groups).
Stratified analysis of participants with urinary incontinence (UI) revealed a significant group × time interaction for the ICIQ-SF (p = 0.007). In this subgroup, between-group comparisons at post-intervention showed mean differences of 4.07 (95% CI: 1.03 to 7.11) for the ICIQ-SF, 14.51 (95% CI: 1.26 to 27.76) for the UDI, and 2.68 (95% CI: −19.21 to 24.57) for the UIQ.
Participants in the CG with UI showed a statistically significant increase in ICIQ-SF symptom severity (p = 0.033), indicating clinical worsening. Additionally, PGI-C responses differed significantly between groups (χ² = 7.23; p = 0.02), with 85% of participants in the EG reporting improvement compared to 45% in the CG. No participants in the EG reported worsening.
Interpretation of results
The intervention demonstrated clinically relevant benefits in pregnant women with GDM and pre-existing urinary incontinence (UI). The reduction in urinary symptoms and the prevention of symptom worsening in the EG suggest a protective effect of the semi-supervised program. These findings indicate that baseline characteristics, such as the presence of symptoms, may influence the response to the intervention, reinforcing the importance of targeted approaches. Furthermore, the high proportion of participants reporting improvement on the PGI-C supports the acceptability and perceived effectiveness of telerehabilitation in this population.