High Intensity Resistance and Aerobic Training Among Women With PCOS

NCT ID: NCT05603169

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-05-10

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment into two groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessor of this study will be kept blind of the participants treatment group

Study Groups

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High Intensity Resistance Training

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.

Group Type ACTIVE_COMPARATOR

High intensity resistance Exercise Training

Intervention Type 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 Aerobic Training

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

Group Type ACTIVE_COMPARATOR

High intensity aerobic Exercise Training

Intervention Type 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

Interventions

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High intensity resistance Exercise Training

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

Intervention Type OTHER

High intensity aerobic Exercise Training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huma Riaz

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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PostGraduate Lab FRAHS

Islamabad, Fedral, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 33638879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33467251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27771865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34567361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31319405 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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RiphahIU Mobeena Maqsood

Identifier Type: -

Identifier Source: org_study_id

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