Polycystic Ovary Syndrome
Conditions
Brief summary
This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.
Detailed description
Women with polycystic ovarian syndrome (PCOS) are at increased risk for glucose intolerance, dyslipidemia, subfertility, obstetric complications and psychosexual disorders. The prevalence of insulin resistance in PCOS can range from 44% to 70%. Studies have indicated that worsening of insulin resistance over time in obese women with PCOS is associated with early development of diabetes mellitus type 2. Interventions like oral contraceptive pills give the higher risk of endometrial cancer for women with PCOS. However, lifestyle correction appears to be the sustainable therapy of PCOS. High-intensity interval training (HIIT) consists of short periods of intense exercise (80% of maximal heart rate) alternated with periods of active recovery or rest. It is a relatively time-efficient training strategy to improve metabolic health and has been considered more enjoyable than moderate-to-vigorous intensity continuous training HIIT increases skeletal muscle oxidative capacity and appears to be effective in improving insulin sensitivity, particularly in those at increased risk type 2 diabetes mellitus. Intermittent fasting had a powerful effect on improvement of glucose metabolism by lowering insulin resistance, improvement of systemic inflammatory diseases and even expansion of life span. So, this study will be conducted to provide new evidences and information about the efficacy of high intensity interval training on insulin resistance in women suffering from PCOS, to manage this problem upon them and add new information to the field of physical therapy.
Interventions
OTHERIntermittent fasting diet group
Fasting for 14 hours and eating window for 10 hours (1400 kcal) as prescribed by nutrition specialist. Intermittent fasting is an approach of eating that focuses on when you eat rather than on what you eat. * During fasting hours (fasting window) the participants are allowed to drink water, tea, coffee and drinks without sugar. * During eating hours (eating window) the participants will follow 1400 kcal diet. * The diet targets recommended with respect to high intake of vegetables (3-4 serve daily), fruits (1-2 serve daily), fish, lean meats and poultry (3-4 serve daily), fat free and low fat dairy products (2-3 serve daily), and legumes, nuts and seeds (4-5 serves per week), carbohydrates (3-4 serve daily).
OTHERHigh intensity interval training
All participants will receive High intensity interval training program in the form of walking on the electronic treadmill for 40 min through 3 phases: Warm-up phase: included walking on the treadmill with light intensity (50% of maximal heart rate (MHR)) for 10 min, Actual phase: included walking on the treadmill with high intensity intervals (80-85% of MHR) repeated for 4 times, with 3-min active recovery at (70% of MHR) between intervals then Cool-downs phase: included walking on the treadmill with light intensity (50% of MHR) for 5 min for 12 weeks.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Obese women with polycystic Ovarian Syndrome (PCOS) as clinically diagnosed by the gynecologist. * Their ages will be ranged from 20 to 35 years old. * Their body mass index will be ranged from 30-40 kg/m2. * Their waist/hip ratio will be \> 0.8. * All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
Exclusion criteria
* Cushing syndrome, diabetes mellitus. * Thyroid dysfunction. * Hypothalamic amenorrhea, ovarian hyperplasia. * Respiratory, renal and liver dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 12 weeks | Body weight will be measured by using weight and height scale before and after treatment program. |
| Body mass index | 12 weeks | It will be calculated by dividing weight in kilograms divided by height meter square. |
| Waist circumference | 12 weeks | The waist circumference will be measured by tape measure from the narrowest point between the lower border of the ribcage and the iliac crest at the end of normal expiration. |
| Hip circumference | 12 weeks | Hip circumference will be measured at the widest part of the hip using the tape measurement. |
| Waist/ hip ratio | 12 weeks | Waist /hip ratio will be calculated by dividing waist circumference by hip circumference. |
| Oral glucose tolerance test | 12 weeks | Venous blood sample will be collected from each participant to determine level of oral glucose tolerance test. The 2-hour plasma glucose level \<140 mg/dL (7.8 MMOL/L) is considered normal. A blood glucose level between 140 and 199 mg/dL (7.8 and 11 MMOL/L) is considered impaired glucose tolerance, or pre- diabetes. |
| Fasting plasma insulin | 12 weeks | Venous blood sample will be collected from each participant to determine level of fasting plasma insulin level at least 8 hours of fasting. Normal insulin level is 3-8µIU/ml, mild insulin resistance is 8-10µIU/ml, moderate insulin resistance is 10-12µIU/ml and severe insulin resistance is \>12 µIU/ml. |
| Glucose /insulin ratio | 12 weeks | A glucose /insulin ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with polycystic Ovarian Syndrome. |
| Homeostasis Model Assessment (HOMA IR) | 12 weeks | Venous blood sample will be collected from each participant to determine level of homeostasis Model Assessment (HOMA IR). It will be calculated for all participants before and after the end of the treatment according to the following equation: HOMA.IR = insulin (MU/L) × glucose (mmol/L)/22.5. HOMA\_IR ≥2.5 should be considered a reasonable indicator of insulin resistance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of quality of life | 12 weeks | Polycystic Ovary Syndrome Quality of Life scale (PCOSQ) will be used. It is composed of 26 items categorized into five sections: emotions (8 items), body hair (5 items), weight concerns (5 items), infertility concerns (4 items), and menstrual irregularities (4 items). Each item is scored with a seven-point. Like rating system where seven represents the best situation and 1 represents the worst situation. The sum of the total points in each item per domain will be evaluated. Ultimately, the first interval values (from 1 to \< 3 points) represent marked effects on health related quality of life (HRQOL); second interval values (from 3 to \< 4 points) represent the marginal effect on HRQOL; third interval values (from 4 to \< 5 points) represent the minimal effect on HRQOL; fourth interval (5 points) represents no effect on HRQOL. |
Countries
Egypt
Contacts
CONTACTHagar Mohamed
CONTACTMohamed Abo Eleinien, Professor
STUDY_CHAIRAzza Nashed, Professor
Cairo University
Outcome results
None listed