search
Back to results

Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in Hepatitis-C Men

Primary Purpose

Hepatitis C, Erectile Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

35 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: men with hepatitis C men diagnosis men with sexual dysfunction (erectile dysfunction) Exclusion Criteria: obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercised group

control group

Arm Description

In this group, Hepatitis-C Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=23) will receive exercise-training sessions (one hour walking on treadmill, for 3 months, three walking sessions per the week)

in this group, Hepatitis-C Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=23) will act as a control (waitlist) group that will receive no trainning

Outcomes

Primary Outcome Measures

International Index of Erectile Function (IIEF-5)
it will assess the sexual dysfunction in men

Secondary Outcome Measures

alanine transaminase
it is an enzyme of liver will assess the liver funtions
aspartate transaminase
it is an enzyme of liver will assess the liver funtions
Rosenberg Self-Esteem Scale
it is a questionnaire that will assess Self-Esteem
Profile of Mood States
it is a questionnaire that will assess mood of men
depression inventory of Beck
it is a questionnaire that will assess depression of men

Full Information

First Posted
November 13, 2022
Last Updated
November 13, 2022
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05624086
Brief Title
Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in Hepatitis-C Men
Official Title
Is There a Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Men With Sexual Dysfunction Complaint and Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Chronic hepatitis C virus (HCV) infection is a systematic disease that affects several aspects of patients' well-being, including physical, mental, social, and sexual quality of life. In recent years, this clinical trial aims to search the Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Hepatitis Men With Sexual Dysfunction Complaint
Detailed Description
Hepatitis Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=46) will be randomized randomly to 23-men exercise-training (one hour walking on treadmill, for 3 months, three walking sessions per the week) hepatitis-C group or 23-men waiting-hepatitis-C group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised group
Arm Type
Experimental
Arm Description
In this group, Hepatitis-C Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=23) will receive exercise-training sessions (one hour walking on treadmill, for 3 months, three walking sessions per the week)
Arm Title
control group
Arm Type
No Intervention
Arm Description
in this group, Hepatitis-C Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=23) will act as a control (waitlist) group that will receive no trainning
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
Hepatitis-C Men With Sexual Dysfunction (erectile dysfunction) Complaint will receive exercise-training sessions (one hour walking on treadmill, for 3 months, three walking sessions per the week)
Primary Outcome Measure Information:
Title
International Index of Erectile Function (IIEF-5)
Description
it will assess the sexual dysfunction in men
Time Frame
It will be measured after 12 weeks of training
Secondary Outcome Measure Information:
Title
alanine transaminase
Description
it is an enzyme of liver will assess the liver funtions
Time Frame
It will be measured after 12 weeks of training
Title
aspartate transaminase
Description
it is an enzyme of liver will assess the liver funtions
Time Frame
It will be measured after 12 weeks of training
Title
Rosenberg Self-Esteem Scale
Description
it is a questionnaire that will assess Self-Esteem
Time Frame
It will be measured after 12 weeks of training
Title
Profile of Mood States
Description
it is a questionnaire that will assess mood of men
Time Frame
It will be measured after 12 weeks of training
Title
depression inventory of Beck
Description
it is a questionnaire that will assess depression of men
Time Frame
It will be measured after 12 weeks of training

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men with hepatitis C men diagnosis men with sexual dysfunction (erectile dysfunction) Exclusion Criteria: obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, Lecturer
Phone
02 0103377553
Email
ali.mohamed@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in Hepatitis-C Men

We'll reach out to this number within 24 hrs