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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942366
• Other study ID #: Mubarra Rao
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: May 2023
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Pakistan	Shamim clinic	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Testosterone	Levels of serum testosterone	0 weeks to 12-weeks
Primary	Body Fat Percentage	Using skinfold method (body caliper)	0-week to 12-weeks
Primary	Physical Activity	International physical activity questionnaire	0-week to 12-weeks