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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

40

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Cairo University

Investigators

  • 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)

October 10, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

November 29, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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