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

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

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.

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Other: Tadalafil 5Mg Tab + continuous and interval exercise; Drug: Tadalafil 5Mg Tab

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo Unoversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercised group; .(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; (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 Names: group 1
ACTIVE_COMPARATOR: non-exercised group; (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; (n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks; Other Names: group 2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2020
• Primary Completion (ANTICIPATED): February 28, 2021
• Study Completion (ANTICIPATED): March 30, 2021

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (ACTUAL): November 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: P.T.REC/012/002918

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No