Obesity-induced ED Response to Combined Effect of Tadalafil Drug in Addition to Interval and Continuous Training
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Five-Item Version of International Index of Erectile Function (IIEF-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sixty sedentary obese married men with BMI > 30 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Tadalafil 5Mg Tab + continuous and interval exercise (Other)
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.
干预措施: Tadalafil 5Mg Tab (Drug)
结局指标
主要结局
Five-Item Version of International Index of Erectile Function (IIEF-5)
时间窗: It will be measured after eight weeks of training
It is a questionnaire of five questions to diagnose ED in male patients
次要结局
- High density lipoprotein(It will be measured after eight weeks of training)
- Triglycerides(It will be measured after eight weeks of training)
- Insulin(It will be measured after eight weeks of training)
- Fasting blood glucose(It will be measured after eight weeks of training)
- The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance(It will be measured after eight weeks of training)
- body mass index(It will be measured after eight weeks of training)
- diastolic blood pressure(It will be measured after eight weeks of training)
- Waist circumference(It will be measured after eight weeks of training)
- systolic blood pressure(It will be measured after eight weeks of training)
研究者
Ali Mohamed Ali ismail
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University