Effects of Senobi Exercise & Aerobic Exercises in Polycystic Ovarian Syndrome (CESAEBMIFQPCOS)

December 28, 2025 updated by: Wajeeha Zia, Riphah International University

Combine Effects of Senobi Exercise & Aerobic Exercises on Body Mass Index, Fatigue and Quality of Life in Polycystic Ovarian Syndrome.

One of the most prevalent endocrine system conditions affecting women of reproductive age is polycystic ovary syndrome (PCOS), also known as hyperandrogenic anovulation (HA) or Stein-Leventhal syndrome. This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity. This study will be randomized controlled trial and will be conducted in Qasim Sandhu medical complex, Iiffat Anwar Medical Complex and OMC Hospital Lahore. Data will be collected 10 months after approval of synopsis. The total duration of treatment will be 6 weeks. Non-probability convenience sampling technique will be used and 32 participants will be recruited in study after randomization according to selection criteria. The subjects will be divided into two groups, 16 participants in each group. Group A (experimental group) will receive senobi exercises and aerobic exercises, 3 days\week for 6 weeks and Group B (control group) will receive aerobic exercises, 3days\week for 6 week.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

One of the most prevalent endocrine system conditions affecting women of reproductive age is polycystic ovary syndrome (PCOS), also known as hyperandrogenic anovulation (HA) or Stein-Leventhal syndrome. This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity. It is usually only diagnosed when complications develop that significantly reduce a patient's quality of life (e.g., hair loss, alopecia, acne, and infertility-related problems). The World Health Organization (WHO) estimates that in 2012 PCOS affected 116 million women globally. Although PCOS can occur at any age, beginning with menarche, the majority of instances are identified between the ages of 20 and 30. Polycystic ovary syndrome (PCOS) is an important and highly prevalent obesity-related comorbidity that develops in girls and women who are genetically predisposed to its development. This study will be randomized controlled trial and will be conducted in Qasim Sandhu medical complex, Iiffat Anwar Medical Complex and OMC Hospital Lahore. Data will be collected 10 months after approval of synopsis. The total duration of treatment will be 6 weeks. Non-probability convenience sampling technique will be used and 32 participants will be recruited in study after randomization according to selection criteria. The subjects will be divided into two groups, 16 participants in each group. Group A (experimental group) will receive senobi exercises and aerobic exercises, 3 days\week for 6 weeks and Group B (control group) will receive aerobic exercises, 3days\week for 6 week. Nutritional counselling and deep breath for 5 minutes will be used as Baseline treatment. The tools that will be used are BMI Calculator for obesity, WHQOL-BREF Questionnaire for Quality of life and multidimensional fatigue inventory (MFI) questionnaire to assess fatigue. After data collection data will be analyzed by using SPSS version 25.

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.
32

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 Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Riphah International University, Lahore

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

No

Description

Inclusion Criteria:

  • Women between the Ages of 18 to 35 Diagnosed with PCOS Menstrual disturbance > 3 months BMI of 29-35kg/m Unmarried and married with multiparous

Exclusion Criteria:

  • Women with other causes of menstrual disturbances (ovarian cancer) Known cardiovascular problems (cardiac arrhythmias) Uncontrolled hypertension or low blood pressure Presence of neurological disease (epilepsy, autism) Orthopedic illness (rheumatoid arthritis, osteoporosis) Cardiopulmonary disease (CVD, COPD) Musculoskeletal injuries (fracture, tendon rupture) Antiobesity medications

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: None (Open Label)

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: Group A (experimental group)
The participants in group A will receive interventional treatment (senobi exercises), 3 days a week for 6 weeks as a supervised exercise program, as well as they will receive aerobic exercises on treadmill with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1 set. Self-stretching exercise for biceps and triceps- 5 reps/5 seconds hold/1 set and walking for 3 alternate days per week for 6 weeks as a home exercise program.
Other: Senobi exercises with aerobics exercises
The participants in group A will receive interventional treatment (senobi exercises), 3 days a week for 6 weeks as a supervised exercise program, as well as they will receive aerobic exercises on treadmill with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1 set. Self-stretching exercise for biceps and triceps- 5 reps/5 seconds hold/1 set and walking for 3 alternate days per week for 6 weeks as a home exercise program.
Experimental: Group B (control group)
The participants in group B will receive aerobic exercises on treadmill ( fig. 2) with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Subjects will be assessed at baseline and after 6 weeks. The post-interventional assessment will be taken and the results will be interpreted. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1 set. Self-stretching exercise for biceps and triceps- 5 reps/5 seconds hold/1 set and walking for 3 alternate days per week for 6 weeks as a home exercise program.
Other: aerobic exercises
The participants in group B will receive aerobic exercises on treadmill with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Subjects will be assessed at baseline and after 6 weeks. The post-interventional assessment will be taken and the results will be interpreted. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1 set. Self-stretching exercise for biceps and triceps- 5 reps/5 seconds hold/1 set and walking for 3 alternate days per week for 6 weeks as a home exercise program.

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
WHQOL-BREF Questionnaire
Time Frame: 6 weeks
WHOQOL-BREF questionnaire is a reliable instrument to measure quality of life. QOL-BREF (WHOQOLBREF) questionnaire which captures many subjective aspects of QOL. This questionnaire is one of the best known instruments that has been developed for cross-cultural comparisons of QOL and is available in many languages. This instrument, by focusing on individuals' own views of their well-being, provides a new perspective on life. Its internal consistency is (α = 0.925).
6 weeks
Multidimensional fatigue inventory
Time Frame: 6 weeks
The Multidimensional Fatigue Inventory (MFI-20) is a valid tool for assessment of fatigue. MFI-20 covering general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation has been widely used in patients with chronic fatigue syndrome. The internal consistency of MFI-20 is (Cronbach's alpha = 0.89).
6 weeks
Body Mass Index
Time Frame: 6 weeks
Body mass index (BMI), is a measurement tool based on a person's height and weight, and allows the classification of individuals into categories such as obese or overweight. Body mass index (BMI) is one of the ways to measure obesity in the population. Body mass index (BMI) can be calculated via mathematical operations where height and weight values are used to estimate the health status of a person.
6 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.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

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.
January 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.
March 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.
July 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).
December 28, 2025

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.
December 28, 2025

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.
January 8, 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.
January 8, 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.
December 28, 2025

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.
December 1, 2025

More Information

Terms related to this study

Keywords

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.
  • Syeda Iram Shahzadi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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