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

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Other: High intensity interval training
Other: Strength training

Registration Number: NCT04942366

Lead Sponsor: Ziauddin University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIIT Group	High intensity interval training	High intensity interval training will be performed thrice a week using a treadmill.
ST Group	Strength training	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).

Primary Outcome Measures

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