Clinical trial NCT04942366: High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.
Official title: Effects of High-Intensity Interval Training and Strength Training On Levels of Testosterone and Physical Activity Among Women With Polycystic Ovary Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: High intensity interval training
Exercise
Polycystic Ovary Syndrome
Physical Therapy
Strength training
Testosterone
Physical activity
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Testosterone
timeFrame: 0 weeks to 12-weeks
measure: Body Fat Percentage
timeFrame: 0-week to 12-weeks
measure: Physical Activity
timeFrame: 0-week to 12-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shamim clinic
state: Sindh
Study officials:
affiliation: Ziauddin University
name: Mubarra Rao
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziauddin University
name: Amna Amir Khan
role: STUDY_DIRECTOR
References: