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Completed

NCT Number: NCT04942366

High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.

This RCT is aimed towards determining the effectiveness of exercises based intervention strategy involving high intensity interval training exercises in improving serum testosterone level, body fat composition and physical activity in hopes to provide a definitive exercise regime for the ever common symptoms of pcos. It will be based on the theory that exercise helps in decreasing testosterone level that in turn decrease high androgen levels in the body, exercise further decreases body fat composition (obesity is a common cause or manifestation of pcos).

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shamim clinic

Karachi, Sindh, 75340, Pakistan

About this study

High intensity interval training will be performed over the course of 12 weeks and will be compared with the group performing strength training. Baseline assessments will be done before the start of the first session and post-test assessment will be done after the last session of the study.

Envelope method is used for the purpose of randomization. 50 envelopes having a title of group A and group B will be made and divided into two (25 in each group). Mutually exclusive technique will be used and the envelope once picked will not be replaced within the groups.

Sample size is calculated by using a previous study conducted in 2015 titled as, 'Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Poly cystic Ovary Syndrome: A Pilot Study' by taking a confidence interval CI of 95%, power of test 80%, standard deviation of 6.3 and mean difference of 5.2, a sample size of 50 is calculated.

For the analysis of the data MedCalc software version 19.0.5. will be used. Descriptive statistics will be performed for the purpose of demographic information and this data will be presented in terms of frequency and percentage. Skewness and Kurtosis will be used in order to determine the normality of data. If the data is normally distributed, then for within the group analysis dependent T test will be performed. However, in case the data is not normally distributed Wilcoxon Sign Rank test will be performed. Independent T test will be performed for the comparison between the two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI:
  • Overweight: 23-24.9 kg/m2.
  • Obese: greater than or equal to 25 kg/m2 .
  • Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.
  • Aged 18-40.
  • High serum testosterone level: normal range 6-86 ng/dl.

Exclusion criteria

  • On-going pregnancy.
  • Any cardiovascular complication.
  • Any other endocrine disorder
  • Any musculoskeletal condition that hinders in performing the exercise training protocol.

Treatment and study plan

High Intensity Interval Training

Other

HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).

Other names: HIIT

Strength training

Other

Strength training will be performed thrice a week, each session will consist of eight dynamic drills.

Primary outcomes

  1. Serum Testosterone

    Time frame: 0 weeks to 12-weeks

    Levels of serum testosterone

  2. Body Fat Percentage

    Time frame: 0-week to 12-weeks

    Using skinfold method (body caliper)

  3. Physical Activity

    Time frame: 0-week to 12-weeks

    International physical activity questionnaire

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2021
Registry last updated
Feb 2, 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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