Combined Effect of Continuous and Interval in Addition to Tadalafil Drug on Erectile Dysfunction

Study Overview
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Brief Summary
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Erectile dysfunction (ED) is the persistent inability to attain and maintain a sufficient erection to permit satisfactory sexual performance. ED, a condition closely related to cardiovascular morbidity and mortality, is frequently associated with obesity. The importance of reducing cardiovascular risk factors remains fundamental to the overall vascular good health of the man, and that includes sexual vascular health. ED shares similar modifiable risks factors with coronary artery disease (CAD). Lifestyle modification that targets CAD risk factors may also lead to improvement in ED.

Detailed Description
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Sixty obese men with ED complaints will be divided to two groups, exercised and non-exercised groups; n= 30 patients in every group. Both groups will receive five milligrams of tadalafil one time per day for 8 weeks but the exercised group only will receive - in addition to tadalafil - combined continuous and interval aerobic training, 3 session weekly for 8 weeks after detecting their target heart rate via the cardiopulmonary exercise test.

Official Title
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Obesity-induced ED Response to Combined Effect of Tadalafil Drug in Addition to Interval and Continuous Training

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Other: Tadalafil 5Mg Tab + continuous and interval exercise
* Drug: Tadalafil 5Mg Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sixty sedentary obese married men with BMI > 30 kg/m2. The age of participants will range from 40-50 years old. Blood pressure will be < 140/90 mm Hg. The patients who will have ED at least from 6 months with IIEF-5 score < 22. Exclusion Criteria: Alcoholic, smoker, hypertensive, diabetic, and addicted patients. Patients with pulmonary, renal, hepatic, and cardiac disorders. Lower limb arthritis or orthopaedic disorders that will hinder the training program. Prostatic inflammation, hyperplasia, and tumors. Participation in a structured sport program in the previous 6 months. previous pelvic and genital surgeries.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercised group<br>.(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks | Other: Tadalafil 5Mg Tab + continuous and interval exercise<br>* (n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks<br>* Other names: group 1;|
| Active Comparator: non-exercised group<br>(n=30) will be sedentary obese men with ED. All participants will receive only five milligrams of tadalafil, one time per day, for eight weeks. | Drug: Tadalafil 5Mg Tab<br>* (n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks<br>* Other names: group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-Item Version of International Index of Erectile Function (IIEF-5) | It is a questionnaire of five questions to diagnose ED in male patients | It will be measured after eight weeks of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | It will be measured via a venous blood sample | It will be measured after eight weeks of training | 
| High density lipoprotein | It will be measured via a venous blood sample | It will be measured after eight weeks of training | 
| Insulin | It will be measured via a venous blood sample | It will be measured after eight weeks of training | 
| Fasting blood glucose | it will be measured via a blood glucose meter | It will be measured after eight weeks of training | 
| The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance | HOMA-IR = [fasting insulin (μU/mL) × fasting glucose (mmol)]/22.5 | It will be measured after eight weeks of training | 
| body mass index | It will be obtained by dividing the weight in Kilograms on the squared height in meter | It will be measured after eight weeks of training | 
| systolic blood pressure | it will be measured by a manual sphygmomanometer | It will be measured after eight weeks of training | 
| diastolic blood pressure | it will be measured by a manual sphygmomanometer | It will be measured after eight weeks of training | 
| Waist circumference | it will be measured by inelastic tape at the umbilicus level | It will be measured after eight weeks of training |