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

November 13, 2022 updated by: Ali Mohamed Ali ismail, Cairo University

Is There a Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Men With Sexual Dysfunction Complaint and Hepatitis C

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercised group
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)
Behavioral: exercise
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)
No Intervention: control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function (IIEF-5)
Time Frame: It will be measured after 12 weeks of training
it will assess the sexual dysfunction in men
It will be measured after 12 weeks of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alanine transaminase
Time Frame: It will be measured after 12 weeks of training
it is an enzyme of liver will assess the liver funtions
It will be measured after 12 weeks of training
aspartate transaminase
Time Frame: It will be measured after 12 weeks of training
it is an enzyme of liver will assess the liver funtions
It will be measured after 12 weeks of training
Rosenberg Self-Esteem Scale
Time Frame: It will be measured after 12 weeks of training
it is a questionnaire that will assess Self-Esteem
It will be measured after 12 weeks of training
Profile of Mood States
Time Frame: It will be measured after 12 weeks of training
it is a questionnaire that will assess mood of men
It will be measured after 12 weeks of training
depression inventory of Beck
Time Frame: It will be measured after 12 weeks of training
it is a questionnaire that will assess depression of men
It will be measured after 12 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Anticipated)

April 15, 2023

Study Completion (Anticipated)

April 15, 2023

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 13, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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