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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05624086

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Erectile Dysfunction	Behavioral: exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

International Index of Erectile Function (IIEF-5) [It will be measured after 12 weeks of training]
it will assess the sexual dysfunction in men

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo Unoversity	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali Ismail, lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT05624086

Other Study ID Numbers: