Effects of Supervised Structured Aerobic Exercise Training Program on Serum BDNF, Androgens Level, Menstrual Irregularity and Quality of Life in Females With Insulin Resistant Polycystic Ovarian Syndrome
Phase: NA
Conditions: Polycystic Ovarian Syndrome (PCOS), Aerobic Exercise, Walking
Sponsor: Riphah International University

Study protocol: 
Title of study  
Effects of Supervised Structured Aerobic Exercise training program on serum BDNF, 
androgens level, menstrual irregularity, aerobic fitness and quality of life in females 
with Insulin resistant polycystic ovarian syndrome. 
Objective (s) of the 
study  
1. To determine the effects of Supervised Structured Aerobic Exercise Training 
Program on quality of life in women with PCOS. 
2. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on BDNF levels in women with PCOS. 
3. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on mental health (stress, depression, anxiety) in women with PCOS. 
4. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on BMI in women with PCOS. 
5. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on menstrual irregularity in women with PCOS. 
6. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on Aerobic fitness in women with PCOS. 
7. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on androgens level in PCOS.  
8. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on Lipid accumulation product in PCOS.  
9. To determine the effect of Supervised Structured Aerobic Exercise Training 
Program on Glycemic control in PCOS.  
Methodology  
(Design, sample 
size, sampling 
technique, Study 
setting, inclusion 
and exclusion 
criteria and Tool) 
Design: RCT Randomized Controlled Trial 
Non-probability Convenient Sampling Technique 
Duration of treatment: 25 weeks 
2 groups; (group A=30) SSAET +Normal routine medication+ Normal Dietary Plan , Other 
group (Group B=30) with normal routine medication + Normal Dietary Plan. 
Patients will be enrolled in the experimental group according to speeds test. 
 
 
TOOLS:  
1. Modified polycystic ovarian syndrome Quality of Life Questionnaire 
(PCOSQOL)- Quality of life 
2. MIQ (Menstrual Irregularity Questionnaire)- Menstrual irregularity 
3. Women's weight in kilograms divided by the square of height in meters- BMI 
 
4. Aerobic fitness- 
YMCA 3-minute Bench Step Test, 3-Minute Step Test: 
You step up and down on a 30 cm (12-inch) step for three minutes at a 
consistent pace, and your heart rate is measured afterward to estimate 
fitness for 1 minute through carotid artery. The more fit you are, the 

lower your recovery heart rate will be, meaning a lower number is a 
better score. 
Compare to Charts: 
Use your age and gender to find the appropriate fitness rating chart, 
such as the YMCA charts.  
Determine Your Level: 
The chart will show whether your 1-minute heart rate falls into 
categories like excellent, good, above average, average, or below 
average fitness. 
YMCA FEMALES Scoring: 
Excellent <109 
Above Average  110 - 117 
Average  118 - 134 
Below Average  135-137 
Poor  >137 
5. BDNF levels- ELISA 
6. Androgens level- Serum SHBG will be measured by coated-tube 
immunoradiometric assay using commercial kits. Testosterone will be 
measured by RIA using commercial enzymatic kits. Free androgen index (FAI) 
will be calculated as testosterone/SHBG × 100. 
Clinical hyperandrogenism (a score of 6 or higher on the modified Ferriman–
Gallwey scale) 
7. Mental health- (Stress, depression & Anxiety) by DASS-21 
Severity Interpretation: Depression: The severity of depression is categorized 
as Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), and Extremely 
Severe (28+). Anxiety: The severity of anxiety is categorized as Normal (0-7), 
Mild (8-9), Moderate (10-14), Severe (15-19), and Extremely Severe (20+). 
Stress: The severity of stress is categorized as Normal (0-14), Mild (15-18), 
Moderate (19-25), Severe (26-33), and Extremely Severe (34+). 
8. Lipid Accumulation Product -Triglycerides test and waist circumference 
The LAP would be calculated as [waist circumference (centimeters) − 58] × 
[triglycerides (millimoles per liter)]  
9. Glycemic control- HOMA IR 
The HOMA-IR score is calculated using your fasting glucose and fasting insulin 
levels: 
HOMA-IR = (Fasting Glucose x Fasting Insulin) / 22.5 
 Rotterdum Criteria for a diagnosis of PCOS 
A diagnosis of PCOS can be made when at least two of the following three criteria 
are met: 
1. Irregular periods or no periods 

2. Higher levels of androgens are present in the blood (hyperandrogenism), shown 
by: 
• 
a blood test, OR 
• 
symptoms such as: 
o 
excess facial or body hair growth 
o 
scalp hair loss 
o 
acne. 
3. Polycystic ovaries are visible on an ultrasound, meaning: 
• 
more than 20 follicles (partly developed eggs) are visible on one or both 
ovaries or 
• 
the size of one or both ovaries is increased (more than 10ml). 
You do not need to have an ultrasound if you have criteria 1 and 2. 
 
In women younger than 20 years, ultrasounds are not recommended. This 
means that irregular periods and hyperandrogenism need to be present for a 
diagnosis of PCOS to be made. 
 
Study Setting: Gyms of Lahore 
Inclusion Criteria : 
 
Age 18 To 35 years Females. 
 
Insuline resistant PCOS type. 
 
Already Diagnosed patients form gyne department according to the Rotterdam criteria. 
 
Both Married and unmarried females. 
 
Nulliparous females. 
Exclusion Criteria : 
 
Post pill PCOS, Inflammatory PCOS  & Adrenal PCOS 
 
Any psychological disease or disorder 
 
Any systemic disease other than PCOS (cushing syndrome, thyroid dysfunction, etc) 
 
Orthopedic conditions (including fracture, dislocation, etc) 
 
Any surgery in past 6 months. 
 
Involved in any other exercise regimen at the same time. 
 
Having any specialized diet plan.  
 
 
 
Data analysis: 
The data will be analysed using SPSS for Windows software, version 25. Statistical 
Significance will be set at P = 0.05. Normality of data will be assessed through Shapiro-Wilks 
test. Following tests will be used: 
Descriptive Statistics: Frequency tables, pie charts, bar charts will be used to Show 
summary of group measurements measured over time. 
Difference within groups: 
 If the normality of data shows parametric result. Difference within group will be calculated 
using Repeated Measure ANOVA. For non-parametric data, Friedman test will be used. 
Difference between Groups:  

Independent sample t test will be used for parametric data. If 
results are non-parametric then, then Mann Whitney U test will be used