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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04623840
Enrollment
60
Registered
2020-11-10
Start date
2020-10-12
Completion date
2021-03-30
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

OTHERTadalafil 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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
40 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
TriglyceridesIt will be measured after eight weeks of trainingIt will be measured via a venous blood sample
High density lipoproteinIt will be measured after eight weeks of trainingIt will be measured via a venous blood sample
InsulinIt will be measured after eight weeks of trainingIt will be measured via a venous blood sample
Fasting blood glucoseIt will be measured after eight weeks of trainingit will be measured via a blood glucose meter
The HOMA-IR (Homeostatic Model Assessment for Insulin ResistanceIt will be measured after eight weeks of trainingHOMA-IR = \[fasting insulin (μU/mL) × fasting glucose (mmol)\]/22.5
body mass indexIt will be measured after eight weeks of trainingIt will be obtained by dividing the weight in Kilograms on the squared height in meter
systolic blood pressureIt will be measured after eight weeks of trainingit will be measured by a manual sphygmomanometer
diastolic blood pressureIt will be measured after eight weeks of trainingit will be measured by a manual sphygmomanometer
Waist circumferenceIt will be measured after eight weeks of trainingit will be measured by inelastic tape at the umbilicus level

Countries

Egypt

Contacts

Primary ContactAli Ismail, lecturer
allooka2012@gmail.com02 01005154209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026