High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): High intensity interval training; Strength training
Intervention type(s): Other; Other
Intervention description(s): 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 will be performed thrice a week, each session will consist of eight dynamic drills.
Other intervention name(s): HIIT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups in which participants are randomly allocated while both groups will perform warm up and cool down session, Group A will perform High intensity interval training and Group B will perform strength training exercises.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: High intensity interval training; Exercise; Polycystic Ovary Syndrome; Physical Therapy; Strength training; Testosterone; Physical activity