Hepatitis CNCT05624086
Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in Hepatitis-C Men
A study testing exercise in people with Hepatitis C and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Hepatitis C, Erectile Dysfunction
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- men with hepatitis C men diagnosis
- men with sexual dysfunction (erectile dysfunction)
Who cannot join
- obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Hepatitis C, Erectile Dysfunction
- Being tested
- exercise
- Medical subject headings
- Hepatitis C, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF-5)
it will assess the sexual dysfunction in men
Measured: It will be measured after 12 weeks of training
Secondary outcomes (5)
alanine transaminase
it is an enzyme of liver will assess the liver funtions
Measured: It will be measured after 12 weeks of training
aspartate transaminase
it is an enzyme of liver will assess the liver funtions
Measured: It will be measured after 12 weeks of training
Rosenberg Self-Esteem Scale
it is a questionnaire that will assess Self-Esteem
Measured: It will be measured after 12 weeks of training
Profile of Mood States
it is a questionnaire that will assess mood of men
Measured: It will be measured after 12 weeks of training
depression inventory of Beck
it is a questionnaire that will assess depression of men
Measured: It will be measured after 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start15 Oct 2022
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624086
- Sponsor's protocol ID
- P.T.REC/012/004114
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05624086
- Acronym / sponsor ID
- P.T.REC/012/004114
- Conditions
- Hepatitis C, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercised group | Experimental | Behavioral: exerciseIn 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) |
| 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 |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men with hepatitis C men diagnosis
- men with sexual dysfunction (erectile dysfunction)
Key exclusion criteria (1 listed)
- obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseHepatitis-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) | Behavioural | Exercised group |
Primary outcome
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
5 secondary outcomes
alanine transaminase
Time frame: It will be measured after 12 weeks of training
aspartate transaminase
Time frame: It will be measured after 12 weeks of training
Rosenberg Self-Esteem Scale
Time frame: It will be measured after 12 weeks of training
Profile of Mood States
Time frame: It will be measured after 12 weeks of training
depression inventory of Beck
Time frame: It will be measured after 12 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Hepatitis C and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF-5) (time frame: It will be measured after 12 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.