High Intensity Resistance and Aerobic Training Among Women With PCOS

NCT05603169 | Completed

• 1 other identifier: RiphahIU Mobeena Maqsood
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

polycystic ovarian syndrome (PCOS) is the most common endocrine female disorder, affecting 4-18% women of reproductive age. The prevalence of PCOS in South Asian women, especially in Pakistani women, is much higher (52%) as compared to white population (20 - 25% in UK). On the basis of cultural, environment, diet and lifestyle practices these women are more prone to development of such disorder. So such public health issue needs to be addressed by strong evidence conducted by a clinical trial. The current study is planned to compare effects of two different exercise protocols of high intensity on anthropometric measures, hormonal profile and quality of life.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (10)

• Body Mass Index

  Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.

  changes from Baseline to 4 weeks

• Body Mass Index

  Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.

  changes from 4 weeks to 8weeks

• Body Mass Index

  Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.

  changes from 8 weeks to 12 weeks

• Waist Hip Ratio

  The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips

  changes from Baseline to 4 weeks

• Waist Hip Ratio

  The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips

  changes from 4 weeks to 8weeks

• Waist Hip Ratio

  The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips

  changes from 8 weeks to 12 weeks

• Polycystic ovarian syndrome questionnaire (PCOSQ)

  The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.

  changes from Baseline to 6 weeks

• Polycystic ovarian syndrome questionnaire (PCOSQ)

  The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function.

  changes from 6 weeks to 12 weeks

• SF-36 QOL

  The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)

  changes from Baseline to 6 weeks

• SF-36 Quality of life

  The SF-36 is a generic patient-reported outcome measure that quantifies health status and measures health-related quality of life.The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)

  changes from 6 weeks to 12 weeks

Secondary Outcomes (1)

• LH/FSH ratios

  changes from Baseline to 3 Months

Study Arms (2)

High Intensity Resistance Training

ACTIVE COMPARATOR

This group will perform high intensity resistance training under supervised physiotherapist in a gym setting. The training load for the first 2 weeks will be 60%-75% of 1RM and increased to 75%-90% of 1RM the following weeks. Load would be increased if the participants will be able to perform 3 sets of 12 repetitions with that load.

Other: High intensity resistance Exercise Training

High Intensity Aerobic Training

ACTIVE COMPARATOR

This group will perform aerobic training under supervision of a physical therapist in gym setting. To calculate exercise intensity, the HR will be maintained at 75-90% of the maximum (HRmax). The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity

Other: High intensity aerobic Exercise Training

Interventions

High intensity resistance Exercise Training OTHER

The resistance training will consist of five resistance exercises (thrice a week on non-consecutive days): squat, leg press, knee extension, lunges, and abdominal crunches. Every participant will be assessed pre and post intervention for hormonal change, BMI/anthropometric measures, fasting glucose and quality of life.The plan will be followed for 12 weeks

High Intensity Resistance Training

High intensity aerobic Exercise Training OTHER

The training protocol will begin with a 5-minute warm-up and will end with a 5-minute cool down, during which the HR will be 60-75% of the HRmax. At least 90 min of exercise per week for obese PCOS patients, with treadmill walking that may include whole-body movement involving more than 2/3 of the muscles, the exercise intensity will be high intensity

High Intensity Aerobic Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with PCOS according to Rotterdam criteria
• Age limit: 18-30
• Women who are not part of planned physical activity for the last six months.
• BMI\<=30

You may not qualify if:

• Women with PCOS who are already on birth control or hormone therapy.
• Women with PCOS who are already are taking some medication for psychological issues
• Women who are already taking cholesterol control medications.
• Women who are a part of any physical activity already

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

PostGraduate Lab FRAHS

Islamabad, Fedral, 04486, Pakistan

Location

Related Publications (6)

• Benham JL, Booth JE, Corenblum B, Doucette S, Friedenreich CM, Rabi DM, Sigal RJ. Exercise training and reproductive outcomes in women with polycystic ovary syndrome: A pilot randomized controlled trial. Clin Endocrinol (Oxf). 2021 Aug;95(2):332-343. doi: 10.1111/cen.14452. Epub 2021 May 3.

  PMID: 33638879 BACKGROUND

• Shele G, Genkil J, Speelman D. A Systematic Review of the Effects of Exercise on Hormones in Women with Polycystic Ovary Syndrome. J Funct Morphol Kinesiol. 2020 May 31;5(2):35. doi: 10.3390/jfmk5020035.

  PMID: 33467251 BACKGROUND

• Mario FM, Graff SK, Spritzer PM. Habitual physical activity is associated with improved anthropometric and androgenic profile in PCOS: a cross-sectional study. J Endocrinol Invest. 2017 Apr;40(4):377-384. doi: 10.1007/s40618-016-0570-1. Epub 2016 Oct 22.

  PMID: 27771865 BACKGROUND

• Wright PJ, Corbett CF, Pinto BM, Dawson RM, Wirth M. Resistance Training as Therapeutic Management in Women with PCOS: What is the Evidence? Int J Exerc Sci. 2021 Aug 1;14(3):840-854. doi: 10.70252/NEEX8658. eCollection 2021.

  PMID: 34567361 BACKGROUND

• Kogure GS, Miranda-Furtado CL, Pedroso DCC, Ribeiro VB, Eiras MC, Silva RC, Caetano LC, Ferriani RA, Calado RT, Dos Reis RM. Effects of Progressive Resistance Training on Obesity Indices in Polycystic Ovary Syndrome and the Relationship With Telomere Length. J Phys Act Health. 2019 Aug 1;16(8):601-607. doi: 10.1123/jpah.2018-0256.

  PMID: 31319405 BACKGROUND

• Mitrašinović-Brulić M, Buljan M, Suljević D. Association of LH/FSH ratio with menstrual cycle regularity and clinical features of patients with polycystic ovary syndrome. Middle East Fertility Society Journal. 2021;26(1):40.

  BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Huma Riaz

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of this study will be kept blind of the participants treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment into two groups

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: November 1, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)