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

NCT ID: NCT04942366

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2021-12-15

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HIIT Group

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

Group Type: EXPERIMENTAL

High intensity interval training

Intervention Type: OTHER

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).

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).

Group Type: ACTIVE_COMPARATOR

Strength training

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: OTHER

Strength training

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

Intervention Type: OTHER

Other Intervention Names

HIIT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Mubarra Rao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mubarra Rao

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University

Amna Amir Khan

Role: STUDY_DIRECTOR

Ziauddin University

Locations

Shamim clinic

Karachi, Sindh, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Mubarra Rao

Identifier Type: -

Identifier Source: org_study_id