Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Five-item international index of erectile function
研究概览
简要总结
This study aimed to assess the effect of IDEP on ED and its associated psychological burden in HD men. Forty HD men with ED were randomly assigned into the IDEP group (this group contained 20 HD men with ED who received intradialytic cycling three times per week) and the control group (this group served as waitlist men). outcomes : Five-Item International Index of Erectile Function (FI-IIEF), ten-question Rosenberg self-esteem scale (TQ-RSES), version three of the Revised UCLA Loneliness Scale (LS), the revised version of Impact of Event Scale (RV-IES), Beck's Depression Inventory (BDI), and State-Trait Anxiety Inventory (S-TAI) were assessed before and after 12 weeks.
详细描述
This study aimed to assess the effect of IDEP on ED and its associated psychological burden in HD men. Forty HD men with ED were randomly assigned into the IDEP group (this group contained 20 HD men with ED who received intradialytic cycling three times per week) and the control group (this group served as waitlist men). outcomes :Five-Item International Index of Erectile Function (FI-IIEF), ten-question Rosenberg self-esteem scale (TQ-RSES), version three of the Revised UCLA Loneliness Scale (LS), the revised version of Impact of Event Scale (RV-IES), Beck's Depression Inventory (BDI), and State-Trait Anxiety Inventory (S-TAI) were assessed before and after 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 48 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men gender
- •Hemodialysis for at least 6 months their
- •Age between 35 to 48 years old.
- •Married patient
- •Education level.
- •The problem of ED was diagnosed by a physician at least 6 months before enrollment in this study.
排除标准
- •prostatic disorders
- •systemic diseases (diabetes mellitus or hypertension)
- •cardiac diseases
- •musculoskeletal issues (e.g. muscle contusion, osteoarthritis, osteoporosis, osteopenia, etc.),
- •persistent hyperkalemia
- •penile shaft problems/implants
- •malignancies, acute/chronic infection or inflammation
- •autoimmune disease
- •cerebrovascular accidents/insults
- •a history of frequent hypoglycaemic episodes,
- •absolute contraindications to cardiopulmonary training/exertion
- •respiratory or liver diseases
- •participation in another structured interdialytic or intradialytic exercise programs
- •neurological diseases
- •consumptions of ED pharmacotherapies
- •previous pelvic surgeries
- •radiotherapy
- •low levels of testosterone or sex hormones,
- •psychological diseases
- •Present history of smoking or alcohol consumption.
研究组 & 干预措施
IDEP group
a pedal exerciser (RTL10273 Deluxe Folding Pedal Exerciser, Drive Medical Co. MPN) was utilized in performing leg cycling exercises while men were sitting. Before starting the session of intradialytic cycling, a 5-minute stretching of the lower limbs was performed as a warming up. Also, as cooling down, the same period of lower limbs' stretching was performed after ending intradialytic cycling
干预措施: intradialytic exercise (Other)
control group
this group served as waitlist men.
结局指标
主要结局
Five-item international index of erectile function
时间窗: 12 weeks
A hard copy of FI-IIEF was given to every HD man with ED to fill it before and after the IDEP.
次要结局
- ten-question Rosenberg self-esteem scale (TQ-RSES),(12 weeks)
研究者
Mohammed Mohamed Mazen
lecturer of physical therapy
Delta University for Science and Technology