Aerobic Exercise Addition to Cognitive Behavioural Treatment in Impotence Metabolic-syndrome Drinkers

November 29, 2025 updated by: Ali Mohamed Ali ismail, Cairo University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Cairo University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • heavy drinking men (forty)
  • men who complain metabolic syndrome
  • men who complain impotence

Exclusion Criteria:

  • cardiac problems
  • renal or hepatic or respiratory or neurogenic diseases,

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group number 1
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).
Behavioral: aerobci physical training and cognitive behavioural treatment
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).
Active Comparator: group number 2
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).
Behavioral: Cognitive behavioural treatment
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
international index of erectile function
Time Frame: it will be measured after 12 weeks
it contain 5 questions that will assess penile erectile functions
it will be measured after 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body mass index
Time Frame: It will be measured after 12 weeks
it will be assessed on empty stomach and empty bladder and empty bowel
It will be measured after 12 weeks
waist circumference
Time Frame: It will be measured after 12 weeks
it will be assessed at ubmlilicus by a tape
It will be measured after 12 weeks
blood systolic pressure
Time Frame: It will be measured after 12 weeks
it will be assessed via sphygmonameter
It will be measured after 12 weeks
blood diastolic pressure
Time Frame: it will be measured after 12 weeks
it will be assessed via sphygmonameter
it will be measured after 12 weeks
triglycerides
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
high density lipoproteins
Time Frame: It will be measured after 12 weeks
it will be assessed via plasma
It will be measured after 12 weeks
blood glucose
Time Frame: It will be measured after 12 weeks
it will assessed vin fasting plasma
It will be measured after 12 weeks
Alcohol abstinence self-efficacy
Time Frame: It will be measured after 12 weeks
the total score of this questionaire will be estimated
It will be measured after 12 weeks
negative affect
Time Frame: It will be measured after 12 weeks
a subscomponent of Alcohol-abstinence self-efficacy questioannire
It will be measured after 12 weeks
Positive and social affect
Time Frame: It will be measured after 12 weeks
a subscomponent of Alcohol-abstinence self-efficacy questioannire
It will be measured after 12 weeks
physical and other concerns
Time Frame: It will be measured after 12 weeks
a subscomponent of Alcohol-abstinence self-efficacy questioannire
It will be measured after 12 weeks
craving and urges
Time Frame: It will be measured after 12 weeks
a subscomponent of Alcohol-abstinence self-efficacy questioannire
It will be measured after 12 weeks
Depression, Anxiety and Stress Scale
Time Frame: It will be measured after 12 weeks
the total score of this questioannaire that contin 21 questions will be scored
It will be measured after 12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali MA Ismail, lecturer, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB000-14233-55

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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