Clinical trial NCT04623840: Combined Effect of Continuous and Interval in Addition to Tadalafil Drug on Erectile Dysfunction
Official title: Obesity-induced ED Response to Combined Effect of Tadalafil Drug in Addition to Interval and Continuous Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Five-Item Version of International Index of Erectile Function (IIEF-5)
timeFrame: It will be measured after eight weeks of training
Secondary outcomes:
measure: Triglycerides
timeFrame: It will be measured after eight weeks of training
measure: High density lipoprotein
timeFrame: It will be measured after eight weeks of training
measure: Insulin
timeFrame: It will be measured after eight weeks of training
measure: Fasting blood glucose
timeFrame: It will be measured after eight weeks of training
measure: The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
timeFrame: It will be measured after eight weeks of training
measure: body mass index
timeFrame: It will be measured after eight weeks of training
measure: systolic blood pressure
timeFrame: It will be measured after eight weeks of training
measure: diastolic blood pressure
timeFrame: It will be measured after eight weeks of training
measure: Waist circumference
timeFrame: It will be measured after eight weeks of training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: