Relaxation Techniques and Pilates for Menopause Symptoms

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Primary objective: To evaluate the effectiveness of relaxation techniques combined with the Pilates method versus the Pilates method alone in improving perimenopausal and menopausal symptoms. Specific objectives: * To determine the baseline status of the patients regarding menopausal symptoms. * To evaluate changes in symptoms, emotional well-being, interoceptive awareness, quality of life, and health-related sleep quality among participants following the intervention in both treatment groups. * To compare changes in symptoms, emotional well-being, interoceptive awareness, quality of life, and health-related sleep quality among participants following the intervention between the two treatment groups. * To examine the participants\' level of adherence to the intervention programs. Task 1 (T1): Patient recruitment and informed consent forms. Task 2 (T2): Initial assessment. Task 3 (T3): Interventions. Task 4 (T4): Final assessment post-treatment. Task 5 (T5): Medium-term assessment one month post-treatment. Task 6 (T6): Data analysis. Task 7 (T7): Publication and dissemination. Approximate number: 50 participants, 25 per group. Recruitment: Women over 40 years of age in the perimenopausal or menopausal stage, presenting with associated symptoms; recruited at a physiotherapy center via referral from the center\'s physiotherapists. Methodology: Assignment to a control group (Pilates, 2 sessions/week) and an intervention group (Pilates + relaxation techniques, 2 sessions/week) for 10 weeks. 60-minute sessions led by physiotherapists. Variables will be measured using: MENQOL for menopausal symptoms and quality of life; SF-12 for general quality of life; DASS-21 for anxiety, depression, and stress; PSQI for sleep quality; and MAIA for the multidimensional assessment of interoceptive awareness; adherence will be tracked via a diary. Data analysis: Normality will be assessed using the Shapiro-Wilk test. A descriptive analysis will be performed using percentages for qualitative variables and mean ± SD or median and IQR for quantitative variables. Between-group comparisons will be conducted using the Student\'s t-test or Mann-Whitney U test, and the Chi-square or Fisher\'s test, as appropriate. Intervention effectiveness will be analyzed using an intention-to-treat approach, comparing pre- and post-intervention changes in the short and medium term via paired t-tests or the Wilcoxon test. Repeated-measures ANOVA will be used for multiple comparisons. Statistical significance will be set at p \< 0.05. Analysis will be performed using SPSS v29.0.
Epistemonikos ID: 507bd9e071dcbc1dc9859b9bc31f39f7dd018b74
First added on: Oct 28, 2026