Clinical Research Directory

Inclusion criteria: Participants must meet all of the following criteria: Age: Women aged 40 years or older at the time of recruitment. Menopausal status: Women who are in the perimenopausal or postmenopausal stage, according to accepted clinical criteria. Menopausal symptoms: Presence of at least one self-reported symptom associated with the menopausal transition, such as vasomotor symptoms, sleep disturbances, mood changes, or musculoskeletal discomfort. Physical ability: Ability to participate safely in a supervised Pilates program and perform the proposed relaxation techniques. Medical stability: Absence of medical conditions that would contraindicate moderate-intensity physical activity or participation in the study interventions. Availability and commitment: Willingness and ability to attend two 60-minute sessions per week for 10 weeks and complete the scheduled assessments. Informed consent: Ability to understand the study procedures and provide written informed consent voluntarily. Assessment compliance: Willingness to complete the study questionnaires, including MENQOL, SF-12, DASS-21, PSQI, and MAIA, at baseline, post-intervention, and one-month follow-up. Language proficiency: Sufficient proficiency in the language of the validated questionnaires used in the study to understand and complete them independently or with standardized assistance. Exclusion criteria: Participants meeting any of the following criteria will be excluded: Contraindications to exercise: Any medical condition or physical limitation that makes participation in the Pilates program unsafe, as determined by an appropriate healthcare professional. Severe musculoskeletal disorders: Acute musculoskeletal injuries, severe chronic pain, or significant functional limitations that prevent the safe performance of the prescribed Pilates exercises. Unstable medical conditions: Uncontrolled cardiovascular, respiratory, neurological, or other systemic conditions that may interfere with safe participation in the intervention. Recent participation in similar programs: Current participation in a structured Pilates program or a systematic relaxation intervention that could substantially influence the study outcomes. Concurrent interventions: Initiation of another structured exercise, relaxation, or mind-body intervention during the study period that could confound the effects of the assigned intervention. Major changes in relevant treatment: Recent initiation or substantial modification of medication or treatment likely to affect menopausal symptoms, mood, or sleep, when these changes could interfere with the interpretation of the results. Severe psychiatric or cognitive impairment: A condition that significantly compromises the participant's ability to understand the study procedures, provide informed consent, or complete the assessments reliably. Inability to comply with the protocol: Anticipated inability to attend the intervention sessions or complete the required assessments and follow-up visits. Concurrent participation in another clinical trial: Participation in another interventional study that could influence the outcomes under investigation. Methodological considerations Before finalizing these criteria for your research protocol, I recommend considering the following points: Menopausal status: Define perimenopause and postmenopause using a recognized clinical framework, such as the STRAW+10 staging system, rather than relying solely on age or symptoms. Menopausal symptoms: Consider requiring a minimum symptom score on the MENQOL only if clinically and scientifically justified. Requiring at least one symptom may be sufficient for your current objectives. Medication and hormone therapy: Avoid automatically excluding all women receiving menopausal hormone therapy or psychotropic medication. Instead, document their use and stability, since broad exclusions could reduce recruitment feasibility and generalizability. Adherence: Low adherence should generally not be an exclusion criterion after randomization. Participants who attend fewer sessions should remain in the intention-to-treat analysis whenever possible. Concurrent interventions: Specify what qualifies as a potentially confounding intervention and whether the restriction applies before recruitment, during the 10-week program, or throughout follow-up. \-