Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

November 28, 2024 updated by: Ali Mohamed Ali ismail, Cairo University
obese male usually complain subjective tinnitus that may affect their sexual function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

this study will enroll forty obese males with subjective tinnitus (bilateral complaint) and sexual dysfunction (erectile dysfunction) who will be divided to group I and group II with an equal number of males within each group (n =20 for the group). all male in both groups will administer low calorie diet for 12 weeks but Group I will additionally administer supervised walking training aerobic training for 45 minutes 3 times per 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
    • Giza
      • Dokki, Giza, Egypt, 11432
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:
        • 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:

  • obese person
  • body mass index less than 40 kg/m2 and more than 30 kg/m2
  • males with subjective tinnitus (bilateral presentation from at least 24 weeks).
  • males with sexual dysfunction (erectile dysfunction from at least 24 weeks)

Exclusion Criteria:

  • cardiac diseased males
  • respiratory diseased males
  • hepatic, musculoskeletal, and hepatic diseased males
  • diabetic males

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 I
This group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks.
Behavioral: aerobic treadmill walking plus low calorie diet
this group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking treadmill aerobic training for 45 minutes 3 times per week for 12 weeks).
Active Comparator: Group II
this group (n =20 for the group) will administer low calorie diet for 12 weeks
Behavioral: low calorie diet
this group (n =20 for the group) will administer low calorie diet 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 assessed after 12 weeks
Arabic form that contain five question will be used
it will be assessed after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body mass index
Time Frame: it will be assessed after 12 weeks
it will be assessed at empty stomach and bladder
it will be assessed after 12 weeks
waist circumference
Time Frame: it will be assessed after 12 weeks
it will be assessed at level of umbilicus
it will be assessed after 12 weeks
visual analogue scale of severity of tinnitus
Time Frame: it will be assessed after 12 weeks
it will be 10-cm line that will be used to assess tinnitus severity
it will be assessed after 12 weeks
visual analogue scale of discomfort induced by tinnitus
Time Frame: it will be assessed after 12 weeks
it will be 10-cm line that will be used to assess discomfort induced by tinnitus
it will be assessed after 12 weeks
tinnitus handicap inventory
Time Frame: it will be assessed after 12 weeks
it is a questionnaire that will assess quality of life impacted by tinnitus
it will be assessed after 12 weeks
triglycerides
Time Frame: it will be measured after 12 weeks
it will be measured in plasma
it will be measured after 12 weeks
high density lipoprotein
Time Frame: it will be measured after 12 weeks
it will be measured in plasma
it will be measured after 12 weeks
atherogenic index
Time Frame: it will be measured after 12 weeks
it will be assessed as and indicator of atherosclerotic status
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 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)

November 6, 2024

Primary Completion (Estimated)

April 6, 2025

Study Completion (Estimated)

April 6, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014233-16

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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