An interventional study of Pilates in Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms, sponsored by Belen Díaz Pulido. Active, not recruiting at 1 site in Spain. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Belen Díaz Pulido · Not applicable, Interventional, and Treatment
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:
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →This is the only study on the registry with Belen Díaz Pulido as lead sponsor.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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.
: 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:
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 , 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 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.
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 sessions/week of Pilates Techniques of 60-minute sessions for 10 weeks
Other: Pilates
2 sessions/week of Pilates Techniques and Techniques of Relaxation of 60-minute sessions for 10 weeks
Other: Pilates
Body awareness and movement techniques will be applied, comparing the effects of the Pilates method in perimenopausal and menopausal women against the effects of the Pilates method combined with relaxation techniques.
menopausal symptoms and quality of life using MENQOL
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
General quality of life using SF-12
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
Anxiety, depression, and stress using DASS-21
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
Sleep quality usign PSQI
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
Multidimensional assessment of interoceptive awareness using MAIA
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment
Adherence using a dairy.
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 3 months is below that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.