NCT05624086

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 13, 2022

Last Update Submit

November 13, 2022

Conditions

Hepatitis CErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function (IIEF-5)

    it will assess the sexual dysfunction in men

    It will be measured after 12 weeks of training

Secondary Outcomes (5)

  • alanine transaminase

    It will be measured after 12 weeks of training

  • aspartate transaminase

    It will be measured after 12 weeks of training

  • Rosenberg Self-Esteem Scale

    It will be measured after 12 weeks of training

  • Profile of Mood States

    It will be measured after 12 weeks of training

  • depression inventory of Beck

    It will be measured after 12 weeks of training

Study Arms (2)

Exercised group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

exerciseBEHAVIORAL

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)

Exercised group

Eligibility Criteria

Age35 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men with hepatitis C men diagnosis
  • men with sexual dysfunction (erectile dysfunction)

You may not qualify if:

  • obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis CErectile Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209ali.mohamed@pt.cu.edu.eg

Ali Ismail, Lecturer

CONTACT

02 0103377553ali.mohamed@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 21, 2022

Study Start

October 15, 2022

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Locations

EG(1)