Clinical trial NCT05603169: High Intensity Resistance and Aerobic Training Among Women With PCOS
Official title: Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment into two groups
Primary purpose: TREATMENT

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.

Detailed description: PCOS is a prevalent condition that is affecting adolescent girls now and has serious impacts on menstrual health and quality of life making them prone to early risk development for chronic metabolic diseases. The comparison between high intensity resistance and aerobic training would give results that which one is more effective in gaining benefits and better effects on overall health both physically(menstrual) as well as mentally that would eventually tell us about the quality of life of such patients.

After the initial screening process, the participants fulfilling the Roterdam criteria, willing to participate in the exercise trial will be recruited and then randomized to the allocated groups of either high intensity resistance or high intensity aerobics. At baseline, their anthropometrics measurements, LH/FSH ratios and fasting plasma glucose test will be done. Patient will be called thrice a week for 3 months for training. It is hypothesized that high intensity resistance or high intensity aerobics will improve anthropometric measures along with hormonal profile and quality of life.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body Mass Index
timeFrame: changes from Baseline to 4 weeks
measure: Body Mass Index
timeFrame: changes from 4 weeks to 8weeks
measure: Body Mass Index
timeFrame: changes from 8 weeks to 12 weeks
measure: Waist Hip Ratio
timeFrame: changes from Baseline to 4 weeks
measure: Waist Hip Ratio
timeFrame: changes from 4 weeks to 8weeks
measure: Waist Hip Ratio
timeFrame: changes from 8 weeks to 12 weeks
measure: Polycystic ovarian syndrome questionnaire (PCOSQ)
timeFrame: changes from Baseline to 6 weeks
measure: Polycystic ovarian syndrome questionnaire (PCOSQ)
timeFrame: changes from 6 weeks to 12 weeks
measure: SF-36 QOL
timeFrame: changes from Baseline to 6 weeks
measure: SF-36 Quality of life
timeFrame: changes from 6 weeks to 12 weeks
Secondary outcomes:
measure: LH/FSH ratios
timeFrame: changes from Baseline to 3 Months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: PostGraduate Lab FRAHS
state: Fedral
Study officials:
affiliation: Riphah International University
name: Huma Riaz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.