Effect of Intradialytic Exercise on Erectile Dysfunction in Hemodialysis Men

NCT ID: NCT06635044

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

intradialytic exercise

Intervention Type 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

control group

this group served as waitlist men.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

48 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Delta University for Science and Technology

OTHER

Sponsor Role collaborator

Mohammed Mohamed Mazen

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Mohamed Mazen

lecturer of physical therapy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rehan Abdelaziz

Damietta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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F.P.T2407028

Identifier Type: -

Identifier Source: org_study_id

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