- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328048
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
Enrolling by invitation
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
32
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
- Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet. 2007 Aug 25;370(9588):685-97. doi: 10.1016/S0140-6736(07)61345-2.
- Barber TM, Franks S. Obesity and polycystic ovary syndrome. Clin Endocrinol (Oxf). 2021 Oct;95(4):531-541. doi: 10.1111/cen.14421. Epub 2021 Jan 31.
- Motta AB. The role of obesity in the development of polycystic ovary syndrome. Curr Pharm Des. 2012;18(17):2482-91. doi: 10.2174/13816128112092482.
- Merkin SS, Phy JL, Sites CK, Yang D. Environmental determinants of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):16-24. doi: 10.1016/j.fertnstert.2016.05.011. Epub 2016 May 27.
- Lujan ME, Chizen DR, Pierson RA. Diagnostic criteria for polycystic ovary syndrome: pitfalls and controversies. J Obstet Gynaecol Can. 2008 Aug;30(8):671-679. doi: 10.1016/S1701-2163(16)32915-2.
- Hashemipour M, Amini M, Iranpour R, Sadri GH, Javaheri N, Haghighi S, Hovsepian S, Javadi AA, Nematbakhsh M, Sattari G. Prevalence of congenital hypothyroidism in Isfahan, Iran: results of a survey on 20,000 neonates. Horm Res. 2004;62(2):79-83. doi: 10.1159/000079392. Epub 2004 Jun 24.
- Liu J, Wu Q, Hao Y, Jiao M, Wang X, Jiang S, Han L. Measuring the global disease burden of polycystic ovary syndrome in 194 countries: Global Burden of Disease Study 2017. Hum Reprod. 2021 Mar 18;36(4):1108-1119. doi: 10.1093/humrep/deaa371.
- Bremer AA. Polycystic ovary syndrome in the pediatric population. Metab Syndr Relat Disord. 2010 Oct;8(5):375-94. doi: 10.1089/met.2010.0039.
- Singh S, Pal N, Shubham S, Sarma DK, Verma V, Marotta F, Kumar M. Polycystic Ovary Syndrome: Etiology, Current Management, and Future Therapeutics. J Clin Med. 2023 Feb 11;12(4):1454. doi: 10.3390/jcm12041454.
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)
January 1, 2026
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
December 28, 2025
First Submitted That Met QC Criteria
December 28, 2025
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
December 28, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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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