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

May 18, 2023 updated by: Mubarra Rao, Ziauddin University

Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75340
        • Shamim clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI:

    1. Overweight: 23-24.9 kg/m2.
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIIT Group
High intensity interval training will be performed thrice a week using a treadmill.
Other: High intensity interval training
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
Active Comparator: ST Group
Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).
Other: Strength training
Strength training will be performed thrice a week, each session will consist of eight dynamic drills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Testosterone
Time Frame: 0 weeks to 12-weeks
Levels of serum testosterone
0 weeks to 12-weeks
Body Fat Percentage
Time Frame: 0-week to 12-weeks
Using skinfold method (body caliper)
0-week to 12-weeks
Physical Activity
Time Frame: 0-week to 12-weeks
International physical activity questionnaire
0-week to 12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat composition
Time Frame: 0-12 weeks
Using skinfold method (body caliper)
0-12 weeks
Physical activity
Time Frame: 0-12 weeks
International physical activity questionnaire
0-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziauddin University

Investigators

  • Principal Investigator: Mubarra Rao, Ziauddin University
  • Study Director: Amna Amir Khan, Ziauddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

June 19, 2021

First Submitted That Met QC Criteria

June 19, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mubarra Rao

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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