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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Other: intradialytic exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt, 34513
    • Rehan Abdelaziz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: intradialytic exercise; 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
No Intervention: control group; this group served as waitlist men.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five-item international index of erectile function	A hard copy of FI-IIEF was given to every HD man with ED to fill it before and after the IDEP.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ten-question Rosenberg self-esteem scale (TQ-RSES),	ten questions/statements. Four-point Likert responses were allocated to every question/statement of the ten-question Rosenberg self-esteem scale (TQ-RSES).	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
version three of the Revised UCLA Loneliness Scale (LS),	This scale was used to assess HD patients' loneliness. Four-point Likert responses were allocated to every question/statement of this 20-item scale.	12 weeks
the revised version of Impact of Event Scale (RV-IES),	The 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	12 weeks
Beck's Depression Inventory (BDI)	This inventory was used to assess depression in this study's participants. The assessed HD patients' BDI contained 21 questions/items	12 weeks
State-Trait Anxiety Inventory (S-TAI)	S-TAI is a psychologically self-reported valid/reliable inventory/questionnaire used to examine two main forms of anxiety	12 weeks

Collaborators and Investigators

• Sponsor: Mohammed Mohamed Mazen
• Collaborators: Delta University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: F.P.T2407028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No