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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623840
• Other study ID #: P.T.REC/012/002918
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Sixty sedentary obese married men with BMI > 30 kg/m2.

2. The age of participants will range from 40-50 years old.

3. Blood pressure will be < 140/90 mm Hg.

4. The patients who will have ED at least from 6 months with IIEF-5 score < 22.

Exclusion Criteria:

1. Alcoholic, smoker, hypertensive, diabetic, and addicted patients.

2. Patients with pulmonary, renal, hepatic, and cardiac disorders.

3. Lower limb arthritis or orthopaedic disorders that will hinder the training program.

4. Prostatic inflammation, hyperplasia, and tumors.

5. Participation in a structured sport program in the previous 6 months.

6. previous pelvic and genital surgeries.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• Tadalafil 5Mg Tab + continuous and interval exercise
(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

Drug:
• Tadalafil 5Mg Tab
(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Triglycerides	It will be measured via a venous blood sample	It will be measured after eight weeks of training
Secondary	High density lipoprotein	It will be measured via a venous blood sample	It will be measured after eight weeks of training
Secondary	Insulin	It will be measured via a venous blood sample	It will be measured after eight weeks of training
Secondary	Fasting blood glucose	it will be measured via a blood glucose meter	It will be measured after eight weeks of training
Secondary	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
Secondary	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
Secondary	systolic blood pressure	it will be measured by a manual sphygmomanometer	It will be measured after eight weeks of training
Secondary	diastolic blood pressure	it will be measured by a manual sphygmomanometer	It will be measured after eight weeks of training
Secondary	Waist circumference	it will be measured by inelastic tape at the umbilicus level	It will be measured after eight weeks of training