Polycystic Ovary Syndrome
Conditions
Keywords
High intensity interval training, Exercise, Polycystic Ovary Syndrome, Physical Therapy, Strength training, Testosterone, Physical activity
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.
Interventions
OTHERHigh 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).
OTHERStrength training
Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Testosterone | 0 weeks to 12-weeks | Levels of serum testosterone |
| Body Fat Percentage | 0-week to 12-weeks | Using skinfold method (body caliper) |
| Physical Activity | 0-week to 12-weeks | International physical activity questionnaire |
Countries
Pakistan
Participant flow
Recruitment details
Serum testosterone was more than normal. Pre-diagnosed PCOS. Overweight or/and obese. Physical activity level (IPAQ).
Participants by arm
| Arm | Count |
|---|---|
| HIIT Group High intensity interval training will be performed thrice a week using a treadmill.
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). | 20 |
| 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).
Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | HIIT Group | ST Group | Total |
|---|---|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 4.92 | 30.5 years STANDARD_DEVIATION 4.8 | 29.3 years STANDARD_DEVIATION 4.86 |
| Body fat percentage | 31.6 percentage STANDARD_DEVIATION 1.79 | 34.1 percentage STANDARD_DEVIATION 2.7 | 32.9 percentage STANDARD_DEVIATION 2.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Serum Testosterone | 2.54 nmol/L STANDARD_DEVIATION 0.07 | 2.54 nmol/L STANDARD_DEVIATION 0.09 | 2.54 nmol/L STANDARD_DEVIATION 0.08 |
| Sex/Gender, Customized Females | 20 participants | 20 participants | 40 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Body Fat Percentage
Using skinfold method (body caliper)
Time frame: 0-week to 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIIT Group | Body Fat Percentage | 0-week | 31.59 Percentage | Standard Deviation 1.79 |
| HIIT Group | Body Fat Percentage | 12-weeks | 29.62 Percentage | Standard Deviation 1.76 |
| ST Group | Body Fat Percentage | 0-week | 34.12 Percentage | Standard Deviation 2.69 |
| ST Group | Body Fat Percentage | 12-weeks | 32.48 Percentage | Standard Deviation 2.87 |
Primary
Physical Activity
International physical activity questionnaire
Time frame: 0-week to 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIIT Group | Physical Activity | 0-week | 3491.15 MET-mins/week | Standard Deviation 211.99 |
| HIIT Group | Physical Activity | 12-weeks | 3928.10 MET-mins/week | Standard Deviation 220.04 |
| ST Group | Physical Activity | 12-weeks | 3716.60 MET-mins/week | Standard Deviation 234.45 |
| ST Group | Physical Activity | 0-week | 3439.60 MET-mins/week | Standard Deviation 243.76 |
Primary
Serum Testosterone
Levels of serum testosterone
Time frame: 0 weeks to 12-weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIIT Group | Serum Testosterone | 0-week | 2.54 nmol/L | Standard Error 0.07 |
| HIIT Group | Serum Testosterone | 12-weeks | 2.39 nmol/L | Standard Error 0.14 |
| ST Group | Serum Testosterone | 0-week | 2.54 nmol/L | Standard Error 0.09 |
| ST Group | Serum Testosterone | 12-weeks | 2.47 nmol/L | Standard Error 0.09 |