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

Not Applicable

• Conditions: Erectile Dysfunction
• Interventions: Other: Tadalafil 5Mg Tab + continuous and interval exercise; Drug: Tadalafil 5Mg Tab

• Registration Number: NCT04623840
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-10-12
• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-09
• Last Update Submitted: 2020-11-09
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercised group	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
non-exercised group	Tadalafil 5Mg Tab	(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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo Unoversity; 🇪🇬 Giza, Egypt