The Effects of 10-weeks Pilates Exercise on Pulmonary Function and Quality of Life in Postmenopausal Women (RCT)

June 26, 2026 updated by: Ayman Mohammad Abu Elmila Mahany, Middle East University

The Effects of 10-weeks Pilates Exercise on Pulmonary Function and Quality of Life in Postmenopausal Women With Normal Body Mass Idex: A Randomized Controlled Trial.

This study will investigate the effect of 10-weeks Pilates exercise on pulmonary function and quality of life in postmenopausal women with normal Body mass index

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is significant because it explores a safe, low-impact, and accessible exercise method that may improve respiratory function and overall quality of life in postmenopausal women. Pilates emphasizes breathing, core strength, and controlled movements, which may be particularly beneficial for women experiencing age-related declines in lung function and physical well-being. The findings can support evidence-based exercise recommendations, promote non-pharmacological interventions, and contribute to improving the health and daily functioning of postmenopausal women.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Postmenopausal women aged 50-60 years.
  • Women who suffered from breathing problems
  • Women with normal body mass index (BMI) 18 to 25 kg/m².
  • Women not related to any other studies.

Exclusion Criteria:

  • Comorbidities such as cardiac or chest diseases (critically ill patients).
  • Receiving hormone replacement therapy.
  • BMI ˃ 25 kg/m² or ˂ 18 kg/m²,
  • Age greater than 60 years or less than 50 years,
  • Use of sedatives, tranquilizers, or antidepressant medications,
  • Musculoskeletal disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: control group
It will consist of 15 postmenopausal women. They will receive diaphragmatic breathing exercises for 5 to 10 minutes in a session, about 3-4 times per day and follow up after 10 weeks
Other: diaphragmatic breathing exercises
is a technique that focuses on deep breathing using the diaphragm rather than shallow chest breaths. It helps improve oxygen intake and promotes relaxation.for 5 to 10 minutes in a session, about 3-4 times per day and follow up after 10 weeks
Experimental: study group
It will consist of 15 postmenopausal women. They will receive diaphragmatic breathing exercises for 5 to 10 minutes in a session, about 3-4 times per day for 10 weeks in addition to pilates exercise for 50-minute per s session for 5 times per week and follow up after 10 weeks
Other: diaphragmatic breathing exercises
is a technique that focuses on deep breathing using the diaphragm rather than shallow chest breaths. It helps improve oxygen intake and promotes relaxation.for 5 to 10 minutes in a session, about 3-4 times per day and follow up after 10 weeks
Other: pilates exercises
low-impact exercise method that focuses on strengthening muscles while improving posture, flexibility, and overall body alignment. It emphasizes controlled movements, proper breathing, and core strength (especially the abdomen, lower back, hips, and pelvis).for 50-minute pers session for 5 times per week and follow up after 10 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity
Time Frame: 10 weeks
will be recorded before and after the intervention using a spirometer, and measured in liters
10 weeks
Forced Expiratory Volume
Time Frame: 10 weeks
will be recorded before and after the intervention using a spirometer, and measured in liters
10 weeks
Peak Expiratory Flow Rate and measured in liters per seconds
Time Frame: 10 weeks
will be recorded before and after the intervention using a spirometer, and measured in liters
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life questionnaire :
Time Frame: 10 weeks

SF-12 Health Survey will be used for the assessment of quality of life. It is a brief, 12-question covering eight health domains, including physical functioning, mental health, Score range:

Lowest: 0 Highest: 100

Interpretation:

0 = worst health status 100 = best health status pain, and social functioning, yielding Physical (PCS) and Mental (MCS) Component Summary scores
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Middle East University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayman MAE Mahany, Horus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT-2026-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD Sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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