NCT06635044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

August 28, 2024

Last Update Submit

October 8, 2024

Conditions

Erectile Dysfunction

Outcome Measures

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.

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Other Outcomes (4)

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

    12 weeks

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

    12 weeks

  • Beck's Depression Inventory (BDI)

    12 weeks

  • +1 more other outcomes

Study Arms (2)

IDEP group

EXPERIMENTAL

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

control group

NO INTERVENTION

this group served as waitlist men.

Interventions

intradialytic exerciseOTHER

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

IDEP group

Eligibility Criteria

Age35 Years - 48 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehan Abdelaziz

Damietta, 34513, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

August 28, 2024

First Posted

October 10, 2024

Study Start

July 1, 2024

Primary Completion

September 15, 2024

Study Completion

September 30, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)