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

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tadalafil 5Mg Tab + continuous and interval exercise
Tadalafil 5Mg Tab
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 50 Years (Adult)MaleDoes not accept 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.

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercised group

non-exercised group

Arm 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

(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.

Outcomes

Primary Outcome Measures

Five-Item Version of International Index of Erectile Function (IIEF-5)
It is a questionnaire of five questions to diagnose ED in male patients

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2020
Last Updated
November 9, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04623840
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised group
Arm Type
Experimental
Arm 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
Arm Title
non-exercised group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Tadalafil 5Mg Tab + continuous and interval exercise
Other Intervention Name(s)
group 1
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5Mg Tab
Other Intervention Name(s)
group 2
Intervention Description
(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks
Primary Outcome Measure Information:
Title
Five-Item Version of International Index of Erectile Function (IIEF-5)
Description
It is a questionnaire of five questions to diagnose ED in male patients
Time Frame
It will be measured after eight weeks of training
Secondary Outcome Measure Information:
Title
Triglycerides
Description
It will be measured via a venous blood sample
Time Frame
It will be measured after eight weeks of training
Title
High density lipoprotein
Description
It will be measured via a venous blood sample
Time Frame
It will be measured after eight weeks of training
Title
Insulin
Description
It will be measured via a venous blood sample
Time Frame
It will be measured after eight weeks of training
Title
Fasting blood glucose
Description
it will be measured via a blood glucose meter
Time Frame
It will be measured after eight weeks of training
Title
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
Description
HOMA-IR = [fasting insulin (μU/mL) × fasting glucose (mmol)]/22.5
Time Frame
It will be measured after eight weeks of training
Title
body mass index
Description
It will be obtained by dividing the weight in Kilograms on the squared height in meter
Time Frame
It will be measured after eight weeks of training
Title
systolic blood pressure
Description
it will be measured by a manual sphygmomanometer
Time Frame
It will be measured after eight weeks of training
Title
diastolic blood pressure
Description
it will be measured by a manual sphygmomanometer
Time Frame
It will be measured after eight weeks of training
Title
Waist circumference
Description
it will be measured by inelastic tape at the umbilicus level
Time Frame
It will be measured after eight weeks of training

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sixty sedentary obese married men with BMI > 30 kg/m2. The age of participants will range from 40-50 years old. Blood pressure will be < 140/90 mm Hg. The patients who will have ED at least from 6 months with IIEF-5 score < 22. Exclusion Criteria: Alcoholic, smoker, hypertensive, diabetic, and addicted patients. Patients with pulmonary, renal, hepatic, and cardiac disorders. Lower limb arthritis or orthopaedic disorders that will hinder the training program. Prostatic inflammation, hyperplasia, and tumors. Participation in a structured sport program in the previous 6 months. previous pelvic and genital surgeries.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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

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