NCT06461585

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of infertility and anovulation. According to the Rotterdam criteria, the prevalence of PCOS is estimated to affect up to 20% of the female population. PCOS is characterized by increased androgen production and decreased ovulation leading to clinical manifestations including acne, hirsutism, male pattern baldness, irregular menstrual cycles, and infertility. In addition to concerns about fertility and hyperandrogenism, PCOS is considered a metabolic disorder, with an increased risk of developing insulin resistance (IR), hyperinsulinemia, dyslipidemia, and low-grade inflammation. In addition to genetic involvement, environmental aspects such as obesity conditions. affect the progression of PCOS or even make patients' clinical conditions worse. Exercise is an important component of PCOS management, and exercises have been shown to improve metabolic and reproductive outcomes in women with PCOS. The study will be a randomized clinical trial. This study will be completed in a time duration of 7 months after the approval of the synopsis. Sample size 32 is calculated by the Epi tool.variable for the sample size is BMI. By the non-probability convenience sampling technique, participants will be divided into 2 groups. Group A the Interventional group will receive SIT and Group B will receive the aerobic exercise. Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes while Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle. The outcome measure will be evaluated by using the BMI Calculator, PCOSQOL, measuring tape Borg scale. After Collecting data from the before and after treatment sessions. The data will be analyzed by using SPSS version 25.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Start

First participant enrolled

December 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 11, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

BMIHigh intensity interval trainingPCOS SyndromeQuality of life

Outcome Measures

Primary Outcomes (2)

  • Modified Borg CR10 RPE scale (For Exertion level)

    PCOSQOL

    8 weeks

  • Waist-to-hip ratio: (Measuring tape)

    BMI Calculator: BMI Calculator:

    8 weeks

Study Arms (2)

Sprint interval training exercise

EXPERIMENTAL

Group A the Interventional group will receive SIT . Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes.

Other: Sprint interval training

Arabic exercises

EXPERIMENTAL

Group B will receive the aerobic exercise. Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle

Other: Sprint interval training

Interventions

Group A the Interventional group will receive SIT . Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes. Group B will receive the aerobic exercise. Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle

Also known as: aerobic exercises
Arabic exercisesSprint interval training exercise

Eligibility Criteria

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

You may qualify if:

  • Diagnosed PCOS
  • Age: 18 - 35 years.
  • BMI ≥25 kg/m2
  • Unmarried females (5)
  • Oligomenorrhea
  • Irregular cycles (Have less than 9 periods in 1 year

You may not qualify if:

  • Congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome
  • Cardiovascular diseases and thrombotic diseases.
  • Systemic illness (Acute or chronic hepatitis or nephritis, musculoskeletal and pulmonary disorder)
  • Taking medications known to affect ovarian function within the past 3 months.
  • Patients suffer from mental problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital, gynae ward

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (8)

  • Paul J, Khanam S, Jain P. Comparative effect of Aerobic Training versus Plyometric Training among Young Obese Women with Poly Cystic Ovarian Syndrome. www ijmaes org.

    BACKGROUND
  • Yilmaz B, Vellanki P, Ata B, Yildiz BO. Metabolic syndrome, hypertension, and hyperlipidemia in mothers, fathers, sisters, and brothers of women with polycystic ovary syndrome: a systematic review and meta-analysis. Fertil Steril. 2018 Feb;109(2):356-364.e32. doi: 10.1016/j.fertnstert.2017.10.018. Epub 2018 Jan 11.

    PMID: 29331234BACKGROUND
  • Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.

    PMID: 36070636BACKGROUND
  • Crosignani PG, Colombo M, Vegetti W, Somigliana E, Gessati A, Ragni G. Overweight and obese anovulatory patients with polycystic ovaries: parallel improvements in anthropometric indices, ovarian physiology and fertility rate induced by diet. Hum Reprod. 2003 Sep;18(9):1928-32. doi: 10.1093/humrep/deg367.

    PMID: 12923151BACKGROUND
  • Welt CK, Carmina E. Clinical review: Lifecycle of polycystic ovary syndrome (PCOS): from in utero to menopause. J Clin Endocrinol Metab. 2013 Dec;98(12):4629-38. doi: 10.1210/jc.2013-2375. Epub 2013 Sep 24.

    PMID: 24064685BACKGROUND
  • Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.

    PMID: 33439300BACKGROUND
  • Repaci A, Gambineri A, Pasquali R. The role of low-grade inflammation in the polycystic ovary syndrome. Mol Cell Endocrinol. 2011 Mar 15;335(1):30-41. doi: 10.1016/j.mce.2010.08.002. Epub 2010 Aug 11.

    PMID: 20708064BACKGROUND
  • Miranda-Furtado CL, Ramos FK, Kogure GS, Santana-Lemos BA, Ferriani RA, Calado RT, Dos Reis RM. A Nonrandomized Trial of Progressive Resistance Training Intervention in Women With Polycystic Ovary Syndrome and Its Implications in Telomere Content. Reprod Sci. 2016 May;23(5):644-54. doi: 10.1177/1933719115611753. Epub 2015 Nov 18.

    PMID: 26586671BACKGROUND

MeSH Terms

Interventions

High-Intensity Interval TrainingExercise

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sabiha Arshad, M.phill

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

December 10, 2023

Primary Completion

June 30, 2024

Study Completion

July 10, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations