NCT07277673

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 29, 2025

Last Update Submit

November 29, 2025

Conditions

Metabolic SyndromeImpotenceHeavy Drinking

Outcome Measures

Primary Outcomes (1)

  • international index of erectile function

    it contain 5 questions that will assess penile erectile functions

    it will be measured after 12 weeks

Secondary Outcomes (13)

  • body mass index

    It will be measured after 12 weeks

  • waist circumference

    It will be measured after 12 weeks

  • blood systolic pressure

    It will be measured after 12 weeks

  • blood diastolic pressure

    it will be measured after 12 weeks

  • triglycerides

    It will be measured after 12 weeks

  • +8 more secondary outcomes

Study Arms (2)

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).

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).

Behavioral: Cognitive behavioural treatment

Interventions

Cognitive behavioural treatmentBEHAVIORAL

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)

group number 2
aerobci physical training and cognitive behavioural treatmentBEHAVIORAL

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).

group number 1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeErectile Dysfunction

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

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

Ali Mohamed, lecturer

CONTACT

01031321109allooka2012@gmail.com

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 29, 2025

First Posted

December 11, 2025

Study Start

October 10, 2025

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

December 11, 2025

Record last verified: 2025-11

Locations

EG(1)