NCT07328048

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 28, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

SenobifemalesBMIFatigueQuality of lifePCOS

Outcome Measures

Primary Outcomes (3)

  • WHQOL-BREF Questionnaire

    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

    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

    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

Study Arms (2)

Group A (experimental group)

EXPERIMENTAL

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

Group B (control group)

EXPERIMENTAL

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

Interventions

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.

Group B (control 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.

Group A (experimental group)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales with PCOS
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 22376149BACKGROUND
  • 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.

    PMID: 33460482BACKGROUND
  • 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.

    PMID: 17720020BACKGROUND
  • 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.

    PMID: 27240194BACKGROUND
  • 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.

    PMID: 18786289BACKGROUND
  • 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.

    PMID: 15237248BACKGROUND
  • 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.

    PMID: 33501984BACKGROUND
  • 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.

    PMID: 20939704BACKGROUND
  • 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.

    PMID: 36835989BACKGROUND

Related Links

MeSH Terms

Conditions

Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 8, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations