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

Ziauddin University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Strength training; Other: High intensity interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT04942366

Mubarra Rao

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

HIIT Group

Experimental group

Description:

High intensity interval training will be performed thrice a week using a treadmill.

Treatment:

Other: High intensity interval training

ST Group

Active Comparator group

Description:

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).

Treatment:

Other: Strength training