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Clinical Trials/NCT04942366
NCT04942366
Completed
Not Applicable

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

Ziauddin University1 site in 1 country50 target enrollmentApril 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovary Syndrome
Sponsor
Ziauddin University
Enrollment
50
Locations
1
Primary Endpoint
Physical Activity
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
December 15, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mubarra Rao

Principal Investigator

Ziauddin University

Eligibility Criteria

Inclusion Criteria

  • Overweight: 23-24.9 kg/m
  • Obese: greater than or equal to 25 kg/m2 .
  • Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.
  • 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.

Outcomes

Primary Outcomes

Physical Activity

Time Frame: 0-week to 12-weeks

International physical activity questionnaire

Body Fat Percentage

Time Frame: 0-week to 12-weeks

Using skinfold method (body caliper)

Serum Testosterone

Time Frame: 0 weeks to 12-weeks

Levels of serum testosterone

Study Sites (1)

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