Heavy DrinkingNCT07277673
Aerobic Exercise Addition to Cognitive Behavioural Treatment in Impotence Metabolic-syndrome Drinkers
A study testing aerobci physical training and cognitive behavioural treatment and Cognitive behavioural treatment in people with Heavy Drinking and Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Cognitive Behavioural Treatment is used as treatment for Heavy Drinking, Impotence, and Metabolic Syndrome. The efficacy of adding aerobic training to this treatment is not tested till now. Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Heavy Drinking, Metabolic Syndrome, Impotence
- What is being tested?
- aerobci physical training and cognitive behavioural treatment and Cognitive behavioural treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- heavy drinking men (forty)
- men who complain metabolic syndrome
- men who complain impotence
Who cannot join
- cardiac problems
- renal or hepatic or respiratory or neurogenic diseases,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Official title: Is There a Benefit of Aerobic Exercise Addition to Cognitive Behavioural Treatment in Heavy Drinking Men With Impotence and Metabolic Syndrome?
Cognitive Behavioural Treatment is used as treatment for Heavy Drinking, Impotence, and Metabolic Syndrome. The efficacy of adding aerobic training to this treatment is not tested till now.
Read the detailed description
Forty men with Heavy Drinking, Impotence, and Metabolic Syndrome will be included. catogorization will be performed to assign them to group number I or group number II. Every group will involve/contain twenty males. Both groups will receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks). Also, Group number I will also adminsiter supervised aerobic training (walking on electrical treamill, 50 minute per the session , three times/week, for 12 weeks).
- Conditions
- Heavy Drinking, Metabolic Syndrome, Impotence
- Being tested
- aerobci physical training and cognitive behavioural treatment, Cognitive behavioural treatment
- Medical subject headings
- Metabolic Syndrome, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobci physical training and cognitive behavioural treatmentBehavioural
Twenty men with Heavy Drinking, Impotence, and Metabolic Syndrome receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks). Also, men will also adminsiter supervised aerobic training (walking on electrical treamill, 50 minute per the session, three times/week, for 12 weeks).
Cognitive behavioural treatmentBehavioural
Twenty men with Heavy Drinking, Impotence, and Metabolic Syndrome will receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | Twenty men with Heavy Drinking, Impotence, and Metabolic Syndrome will be included. Men will receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks). Also, men will also adminsiter supervised aerobic training (walking on electrical treamill, 50 minute per the session, three times/week, for 12 weeks). Receives: Behavioral: aerobci physical training and cognitive behavioural treatment |
| group number 2 | Active comparator | Twenty men with Heavy Drinking, Impotence, and Metabolic Syndrome will be included. Men will receive Cognitive Behavioural Treatment (30 minute per the session, three times/week, for 12 weeks). Receives: Behavioral: Cognitive behavioural treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
international index of erectile function
it contain 5 questions that will assess penile erectile functions
Measured: it will be measured after 12 weeks
Secondary outcomes (13)
body mass index
it will be assessed on empty stomach and empty bladder and empty bowel
Measured: It will be measured after 12 weeks
waist circumference
it will be assessed at ubmlilicus by a tape
Measured: It will be measured after 12 weeks
blood systolic pressure
it will be assessed via sphygmonameter
Measured: It will be measured after 12 weeks
blood diastolic pressure
it will be assessed via sphygmonameter
Measured: it will be measured after 12 weeks
triglycerides
it will be assessed in plasma
Measured: It will be measured after 12 weeks
high density lipoproteins
it will be assessed via plasma
Measured: It will be measured after 12 weeks
blood glucose
it will assessed vin fasting plasma
Measured: It will be measured after 12 weeks
Alcohol abstinence self-efficacy
the total score of this questionaire will be estimated
Measured: It will be measured after 12 weeks
negative affect
a subscomponent of Alcohol-abstinence self-efficacy questioannire
Measured: It will be measured after 12 weeks
Positive and social affect
a subscomponent of Alcohol-abstinence self-efficacy questioannire
Measured: It will be measured after 12 weeks
physical and other concerns
a subscomponent of Alcohol-abstinence self-efficacy questioannire
Measured: It will be measured after 12 weeks
craving and urges
a subscomponent of Alcohol-abstinence self-efficacy questioannire
Measured: It will be measured after 12 weeks
Depression, Anxiety and Stress Scale
the total score of this questioannaire that contin 21 questions will be scored
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start10 Oct 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy DrinkingStudies 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
- 40 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 MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277673
- Sponsor's protocol ID
- IRB000-14233-55
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Benefit of Aerobic Exercise Addition to Cognitive Behavioural Treatment in Heavy Drinking Men With Impotence and Metabolic Syndrome?
- ClinicalTrials.gov ID
- NCT07277673
- Acronym / sponsor ID
- IRB000-14233-55
- Conditions
- Heavy Drinking, Metabolic Syndrome, Impotence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
Cognitive Behavioural Treatment is used as treatment for Heavy Drinking, Impotence, and Metabolic Syndrome. The efficacy of adding aerobic training to this treatment is not tested till now.
Detailed description
Forty men with Heavy Drinking, Impotence, and Metabolic Syndrome will be included. catogorization will be performed to assign them to group number I or group number II. Every group will involve/contain twenty males. Both groups will receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks). Also, Group number I will also adminsiter supervised aerobic training (walking on electrical treamill, 50 minute per the session , three times/week, for 12 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: aerobci physical training and cognitive behavioural treatmentTwenty men with Heavy Drinking, Impotence, and Metabolic Syndrome will be included. Men will receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks). Also, men will also adminsiter supervised aerobic training (walking on electrical treamill, 50 minute per the session, three times/week, for 12 weeks). |
| group number 2 | Active comparator | Behavioral: Cognitive behavioural treatmentTwenty men with Heavy Drinking, Impotence, and Metabolic Syndrome will be included. Men will receive Cognitive Behavioural Treatment (30 minute per the session, three times/week, for 12 weeks). |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- heavy drinking men (forty)
- men who complain metabolic syndrome
- men who complain impotence
Key exclusion criteria (2 listed)
- cardiac problems
- renal or hepatic or respiratory or neurogenic diseases,
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 |
|---|---|---|
| aerobci physical training and cognitive behavioural treatmentTwenty men with Heavy Drinking, Impotence, and Metabolic Syndrome receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks). Also, men will also adminsiter supervised aerobic training (walking on electrical treamill, 50 minute per the session, three times/week, for 12 weeks). | Behavioural | group number 1 |
| Cognitive behavioural treatmentTwenty men with Heavy Drinking, Impotence, and Metabolic Syndrome will receive Cognitive Behavioural Treatment (30 minute per the session , three times/week, for 12 weeks) | Behavioural | group number 2 |
Primary outcome
international index of erectile function
Time frame: it will be measured after 12 weeks
it contain 5 questions that will assess penile erectile functions
13 secondary outcomes
body mass index
Time frame: It will be measured after 12 weeks
waist circumference
Time frame: It will be measured after 12 weeks
blood systolic pressure
Time frame: It will be measured after 12 weeks
blood diastolic pressure
Time frame: it will be measured after 12 weeks
triglycerides
Time frame: It will be measured after 12 weeks
high density lipoproteins
Time frame: It will be measured after 12 weeks
blood glucose
Time frame: It will be measured after 12 weeks
Alcohol abstinence self-efficacy
Time frame: It will be measured after 12 weeks
negative affect
Time frame: It will be measured after 12 weeks
Positive and social affect
Time frame: It will be measured after 12 weeks
physical and other concerns
Time frame: It will be measured after 12 weeks
craving and urges
Time frame: It will be measured after 12 weeks
Depression, Anxiety and Stress Scale
Time frame: It will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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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.
Ali MA 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 aerobci physical training and cognitive behavioural treatment and Cognitive behavioural treatment in people with Heavy Drinking and Metabolic Syndrome, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (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 (time frame: it will be measured after 12 weeks). 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 11 Dec 2025.