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Completed

NCT Number: NCT05603169

High Intensity Resistance and Aerobic Training Among Women With PCOS

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.

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Key information

Conditions

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

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

PostGraduate Lab FRAHS

Islamabad, Fedral, 04486, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

  1. Body Mass Index

    Time frame: changes from Baseline to 4 weeks

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

  2. Body Mass Index

    Time frame: changes from 4 weeks to 8weeks

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

  3. Body Mass Index

    Time frame: changes from 8 weeks to 12 weeks

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

  4. Waist Hip Ratio

    Time frame: changes from Baseline to 4 weeks

    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

  5. Waist Hip Ratio

    Time frame: changes from 4 weeks to 8weeks

    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

  6. Waist Hip Ratio

    Time frame: changes from 8 weeks to 12 weeks

    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

  7. Polycystic ovarian syndrome questionnaire (PCOSQ)

    Time frame: changes from Baseline to 6 weeks

    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.

  8. Polycystic ovarian syndrome questionnaire (PCOSQ)

    Time frame: changes from 6 weeks to 12 weeks

    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.

  9. SF-36 QOL

    Time frame: changes from Baseline to 6 weeks

    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)

  10. SF-36 Quality of life

    Time frame: changes from 6 weeks to 12 weeks

    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)

Secondary outcomes

  1. LH/FSH ratios

    Time frame: changes from Baseline to 3 Months

    Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and LH/FSH ratio will be measured when considering a PCOS diagnosis. The LH/FSH ratio is a valid and frequently employed method to test the ovulation and menstrual health of such women and have been reported by many studies

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of High Intensity Resistance and Aerobic Training Among Women With Polycystic Ovarian Syndrome.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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