Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men (IDEP)

Mohammed Mohamed Mazen

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Other: intradialytic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06635044

F.P.T2407028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 35 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

IDEP group

Experimental group

Description:

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

Treatment:

Other: intradialytic exercise

control group

No Intervention group

Description:

this group served as waitlist men.