Clinical trial NCT06635044: Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men
Official title: Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
Collaborators: name: Delta University for Science and Technology
First posted: 2024-10-10
Enrollment: 40
Sex: MALE
Minimum age (years): 35
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Five-item international index of erectile function
timeFrame: 12 weeks
Secondary outcomes:
measure: ten-question Rosenberg self-esteem scale (TQ-RSES),
timeFrame: 12 weeks
Other outcomes:
measure: version three of the Revised UCLA Loneliness Scale (LS),
timeFrame: 12 weeks
measure: the revised version of Impact of Event Scale (RV-IES),
timeFrame: 12 weeks
measure: Beck's Depression Inventory (BDI)
timeFrame: 12 weeks
measure: State-Trait Anxiety Inventory (S-TAI)
timeFrame: 12 weeks
Locations:
city: Damietta
country: Egypt
facility: Rehan Abdelaziz
Study officials:
References: