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

NCT ID: NCT04623840

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2021-03-30

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Tadalafil 5Mg Tab + continuous and interval exercise

Intervention Type OTHER

(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

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.

Group Type ACTIVE_COMPARATOR

Tadalafil 5Mg Tab

Intervention Type DRUG

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type DRUG

Other Intervention Names

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group 1 group 2

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo Unoversity

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ismail, lecturer

Role: CONTACT

Phone: 02 01005154209

Email: [email protected]

Facility Contacts

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Ali Ismail, lecturer

Role: primary

Other Identifiers

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P.T.REC/012/002918

Identifier Type: -

Identifier Source: org_study_id