- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06461585
Effects of Sprint Interval Training Versus Arabic Exercises BMI
Effects of Sprint Interval Training Versus Arabic Exercises BMI Waist-to-hip Ratio and Quality of Life in Obese Women PCOS
Study Overview
Detailed Description
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. The study will be conducted in the settings of Jinnah Hospital Lahore, Shapes Gym, and UFC Gym. 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.
Keywords: Body Mass Index, High-Intensity Interval Training, Polycystic Ovary Syndrome, Quality of Life
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iqbal Tariq, PhD
- Phone Number: 03458236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Jinnah Hospital, gynae ward
-
Sub-Investigator:
- Wajeeha Naveed, DPT
-
Contact:
- Sabiha arshad, m.phill
- Email: s.arshad@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosed PCOS
- Age: 18 - 35 years.
- BMI ≥25 kg/m2
- Unmarried females (5)
- Oligomenorrhea
- Irregular cycles (Have less than 9 periods in 1 year
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sprint interval training exercise
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 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
Other Names:
|
|
Experimental: Arabic exercises
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Borg CR10 RPE scale (For Exertion level)
Time Frame: 8 weeks
|
PCOSQOL
|
8 weeks
|
|
Waist-to-hip ratio: (Measuring tape)
Time Frame: 8 weeks
|
BMI Calculator: BMI Calculator: |
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.Phill, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RECRCR&AHS-23-0573
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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