Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated SymptomsNCT07897812
Relaxation Techniques and Pilates for Menopause Symptoms
A study testing Pilates in people with Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms, run by Belen Díaz Pulido at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
- What is being tested?
- Pilates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2026to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Relaxation Techniques Combined With Pilates on Perimenopause and Menopause Symptoms: A Controlled Clinical Trial
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:
Read more
- 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.
- Being tested
- Pilates
- Keywords
- Perimenopause, Menopause, Pilates-Based Exercises, Relaxation Therapy, Anxiety, Interoceptive Awareness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Active comparator | 2 sessions/week of Pilates Techniques of 60-minute sessions for 10 weeks Receives: Other: Pilates |
| Pilates + Relaxation techniques Group | Experimental | 2 sessions/week of Pilates Techniques and Techniques of Relaxation of 60-minute sessions for 10 weeks Receives: Other: Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
menopausal symptoms and quality of life using MENQOL
Measured: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
General quality of life using SF-12
Measured: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
Anxiety, depression, and stress using DASS-21
Measured: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
Sleep quality usign PSQI
Measured: From enrollment to the end of treatment at 10 weeks; and one month post-treatment.
Multidimensional assessment of interoceptive awareness using MAIA
Measured: From enrollment to the end of treatment at 10 weeks; and one month post-treatment
Secondary outcomes (1)
Adherence using a dairy.
Measured: From enrollment to the end of treatment at 10 weeks; and one month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Jul 2026
- Primary completion12 Nov 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belen Díaz Pulido
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Sponsor-investigator, Belen Díaz Pulido, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897812
- Sponsor's protocol ID
- CEUMA: 137-2026-H
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Relaxation Techniques Combined With Pilates on Perimenopause and Menopause Symptoms: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07897812
- Acronym / sponsor ID
- CEUMA: 137-2026-H
- Keywords
- Perimenopause, Menopause, Pilates-Based Exercises, Relaxation Therapy, Anxiety, Interoceptive Awareness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Belen Díaz PulidoUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Active comparator | Other: Pilates2 sessions/week of Pilates Techniques of 60-minute sessions for 10 weeks |
| Pilates + Relaxation techniques Group | Experimental | Other: Pilates2 sessions/week of Pilates Techniques and Techniques of Relaxation of 60-minute sessions for 10 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PilatesBody 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. | Other | Pilates + Relaxation techniques Group, Pilates Group |
Primary outcome
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
1 secondary outcome
Adherence using a dairy.
Time frame: From enrollment to the end of treatment at 10 weeks; and one month post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates in people with Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms, run by Belen Díaz Pulido at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.