Effect of High Intensity Interval Training on Insulin Resistance in Polycystic Ovarian Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorCairo University

About this trial

This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Cushing syndrome, diabetes mellitus.

Thyroid dysfunction.

Hypothalamic amenorrhea, ovarian hyperplasia.

Respiratory, renal and liver dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent fasting diet group

    Other intervention

    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).

  • High intensity interval training

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intermittent fasting diet groupActive comparator 1 intervention
Group B: High Intensity Interval Training and intermittent fasting diet groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Body weight

Body weight will be measured by using weight and height scale before and after treatment program.

Time frame
12 weeks
2

Body mass index

It will be calculated by dividing weight in kilograms divided by height meter square.

Time frame
12 weeks
3

Waist circumference

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.

Time frame
12 weeks
4

Hip circumference

Hip circumference will be measured at the widest part of the hip using the tape measurement.

Time frame
12 weeks

Secondary outcomes

1

Assessment of quality of life

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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