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Completed

NCT Number: NCT06635044

Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

35 year–48 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rehan Abdelaziz

Damietta, 34513, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intradialytic exercise

Other

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

Primary outcomes

  1. Five-item international index of erectile function

    Time frame: 12 weeks

    A hard copy of FI-IIEF was given to every HD man with ED to fill it before and after the IDEP.

Secondary outcomes

  1. ten-question Rosenberg self-esteem scale (TQ-RSES),

    Time frame: 12 weeks

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

Other outcomes

  1. version three of the Revised UCLA Loneliness Scale (LS),

    Time frame: 12 weeks

    This scale was used to assess HD patients' loneliness. Four-point Likert responses were allocated to every question/statement of this 20-item scale.

  2. the revised version of Impact of Event Scale (RV-IES),

    Time frame: 12 weeks

    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

  3. Beck's Depression Inventory (BDI)

    Time frame: 12 weeks

    This inventory was used to assess depression in this study's participants. The assessed HD patients' BDI contained 21 questions/items

  4. State-Trait Anxiety Inventory (S-TAI)

    Time frame: 12 weeks

    S-TAI is a psychologically self-reported valid/reliable inventory/questionnaire used to examine two main forms of anxiety

Sponsors and collaborators

Lead sponsor

Mohammed Mohamed Mazen

Other

Collaborators

  • Delta University for Science and Technology

Registry information

Acronym: IDEP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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