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Spots Global Cancer Trial Database for High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.

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Trial Identification

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

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

Study ID: NCT04942366

Study Description

Brief Summary: 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).

Detailed Description: 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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Shamim clinic, Karachi, Sindh, Pakistan

Contact Details

Name: Mubarra Rao

Affiliation: Ziauddin University

Role: PRINCIPAL_INVESTIGATOR

Name: Amna Amir Khan

Affiliation: Ziauddin University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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