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CompletedNCT06635044IDEPUpdated Oct 10, 2024

Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men

An interventional study of intradialytic exercise in Erectile Dysfunction, sponsored by Mohammed Mohamed Mazen. Completed at 1 site in Egypt. Open to male participants aged 35 Years to 48 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Mohammed Mohamed Mazen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
35 Years to 48 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Erectile Dysfunction

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

This is the only study on the registry with Mohammed Mohamed Mazen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 48 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • No intervention
    control group

    this group served as waitlist men.

Interventions

  • Otherintradialytic 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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).

    Time frame: 12 weeks

Other outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

  3. 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

    Time frame: 12 weeks

  4. 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

    Time frame: 12 weeks

07

Study locations

1 site
  • Rehan Abdelaziz
    Damietta, 34513, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06635044
Lead sponsor
Mohammed Mohamed Mazen
Collaborators
Delta University for Science and Technology
Responsible party
Mohammed Mohamed Mazen (lecturer of physical therapy, Delta University for Science and Technology) — Sponsor-investigator
First posted
Oct 10, 2024
Start date
Jul 1, 2024
Primary completion
Sep 15, 2024
Completion
Sep 30, 2024
Last update
Oct 10, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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