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Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men

Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06635044
Acronym
IDEP
Enrollment
40
Registered
2024-10-10
Start date
2024-07-01
Completion date
2024-09-30
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

HD men came to the HD unit three times weekly to receive their dialysis session which consumed 3-4 hours. During the first two hours of the men's dialysis session, 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

Sponsors

Delta University for Science and Technology
CollaboratorOTHER
Mohammed Mohamed Mazen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
35 Years to 48 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Five-item international index of erectile function12 weeksA hard copy of FI-IIEF was given to every HD man with ED to fill it before and after the IDEP.

Secondary

MeasureTime frameDescription
ten-question Rosenberg self-esteem scale (TQ-RSES),12 weeksten questions/statements. Four-point Likert responses were allocated to every question/statement of the ten-question Rosenberg self-esteem scale (TQ-RSES).

Other

MeasureTime frameDescription
version three of the Revised UCLA Loneliness Scale (LS),12 weeksThis scale was used to assess HD patients' loneliness. Four-point Likert responses were allocated to every question/statement of this 20-item scale.
the revised version of Impact of Event Scale (RV-IES),12 weeksThe RV-IES tool/questionnaire is commonly utilized in clinical trials to monitor subjects' stress to recent and/or specific traumatic events. Five-point Likert responses were allocated to every question/statement of this 22-item scale
Beck's Depression Inventory (BDI)12 weeksThis inventory was used to assess depression in this study's participants. The assessed HD patients' BDI contained 21 questions/items
State-Trait Anxiety Inventory (S-TAI)12 weeksS-TAI is a psychologically self-reported valid/reliable inventory/questionnaire used to examine two main forms of anxiety

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026