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

Cairo University (CU)

Status: Unknown

Conditions: Erectile Dysfunction

Treatments: Other: Tadalafil 5Mg Tab + continuous and interval exercise; Drug: Tadalafil 5Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT04623840

P.T.REC/012/002918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Exercised group

Experimental group

Description:

.(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

Treatment:

Other: Tadalafil 5Mg Tab + continuous and interval exercise

non-exercised group

Active Comparator group

Description:

(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.

Treatment:

Drug: Tadalafil 5Mg Tab