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

Sponsor

Ziauddin University (Other)

Overall Status

Completed

CT.gov ID

NCT04942366

Collaborator

(none)

Enrollment

Location

Arms

5.5

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: High intensity interval training Other: Strength training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

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.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)

Masking Description:

While the exercise protocol will be explained to the participant and care giver however the they will be blinded regarding which is intervention group or control group and which exercise is the main interventional exercise will not be disclosed.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 12, 2021

Actual Primary Completion Date :

Sep 26, 2021

Actual Study Completion Date :

Sep 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIIT Group High intensity interval training will be performed thrice a week using a treadmill.	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). Other Names: HIIT
Active Comparator: ST Group 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).	Other: Strength training Strength training will be performed thrice a week, each session will consist of eight dynamic drills.

Arm

Intervention/Treatment

Experimental: HIIT Group

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

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).

Other Names:

HIIT

Active Comparator: ST Group

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).

Other: Strength training

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

Outcome Measures

Primary Outcome Measures

Serum testosterone [0-12 weeks]
Levels of serum testosterone

Secondary Outcome Measures

Body fat composition [0-12 weeks]
Using skinfold method (body caliper)
Physical activity [0-12 weeks]
International physical activity questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI:

Overweight: 23-24.9 kg/m2.
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.