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NCT Number: NCT06198348

Aerobic Training With and Without Resistance Training in Polycystic Ovarian Syndrome

Polycystic ovary syndrome (PCOS) characterized by a chronic disorder in ovulation along with hyperandrogenism has become one of the most common endocrine disorders in women of reproductive age with an estimated 5%-15% prevalence. It has the symptoms such as menstrual disorders, infertility, hyperandrogenism, obesity, hirsutism and acne. PCOS is linked to Psychological morbidities e.g. increased risk of stress, depression, low self-esteem, poor body image, and reduced health-related quality of life. Approximately 75% of people with PCOS have a fat accumulation in the central area of the body.

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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–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

About this study

A Randomized controlled trial will be conducted to determine the effects of Aerobic training with and without resistance training on the waist to hip ratio, QoL and menstrual dysfunction in polycystic ovarian syndrome. A sample size of 22 PCOS women's will be taken, Data will be collected from Jinnah Hospital Lahore by using PCOSQ and SF-36 questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. The interventions will be provided for 30 mints for 3 days per week for 2 months. All participants in both groups will be evaluated before and after the treatment programs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-40yrs
  • Waist to hip ratio >87(20)
  • Women who are diagnosed according to Rotterdam criteria e.g. oligo/anovulation, hyperandrogenism, and polycystic ovaries.(21)
  • Female who physically able to performs exercise

Exclusion criteria

  • Women who are smoking and using drugs for depression.
  • Married women
  • Women with other pathological conditions like diabetes and thyroid diseases.
  • Females who are not able to perform resistant exercise

Treatment and study plan

Aerobic Exercise

Other

Treatment Protocol to Group A It consists of patients who will receive aerobic exercise sessions 3 times per week for 8 weeks. Every session will be of 30 minutes.

It will include warm up phase, active phase and cool down phase Warm-up phase:

In which each participant will walk at 80 m/min at for 5 min.

Active phase:

Brisk walking or treadmill:

In which each participant will perform brisk walking for 15 mints initially. After that gradually duration of brisk walking will increase.

Aerobic Exercises with Resistance training

Other

These groups will perform these exercises:

Aerobic exercise +resistance exercises Exercise

Session: 3 days per week Time of exercise session: 30-45 min

After following protocol of aerobic exercise as mentioned above the subjects will perform resistance exercises. These Exercises will perform:

  • Leg press (dual leg press):

Leg press targets the Glutes "Quadriceps or quads .but they also work your "Hamstrings".

  • Crunches:

Crunches Target the abdominal muscles specifically rectus abdominis and obliques.

  • Squats:

Squats targets the adductor muscles of the hip, glutes and rectus abdominis muscle Leg Extension

Total Exercise plan for 12 weeks:

1-2 weeks: Repitations: 10-15 times

No of sets: 1 set Resistance: minimum 3-4 weeks:

Repitations: 10-15 times

No of sets: 2 set Resistance: moderate 5-6 weeks:

Repitations: 15-16 times

No of sets: 2 set Resistance: moderate 7-8 weeks:

Repitations: 15-16 times No of sets: 2 set

Primary outcomes

  1. SF-36 Questionnaire

    Time frame: 8 weeks

    QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements.validity of SF-36 Questionnaire is 0.90 Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale.

  2. Self-administered PCOSQ

    Time frame: 8 weeks

    All the participants filled up the self-administered PCOSQ. PCOS Questionnaire has 26 items divided into 5 domains: emotions (8 items), body hair (5 items), weight (5 items), infertility (4 items), and menstrual problems (4 items). Each question is associated with a 7point scale in which 7 represents optimal function and 1 represents the poorest Function. PCOSQ dimensions were internally reliable with Cronbach's a scores ranging from 0.70 to 0.97.

  3. Measuring Tape

    Time frame: 8 weeks

    Waist circumference (WC) was measured with the participant in the standing position, with arms at the side of the body, feet together, and with a relaxed abdomen. For WC, a horizontal measurement was obtained on the narrower part of the dorsum (above the navel and below the xiphoid process.

    Hip circumference (HC) was measured using the same positioning, as the region with the largest circumference of the buttocks. Waist-to-hip ratio (WHR) was measured by dividing the WC value by the HC value

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Aerobic Training With and Without Resistance Training on Waist to Hip Ratio, Quality of Life and Menstrual Dysfunction in Polycystic Ovarian Syndrome.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Apr 19, 2024

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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