Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

Not Applicable

Recruiting

• Conditions: Obesity; Tinnitus, Subjective; Erectile Dysfunction

• Registration Number: NCT06716125
• Lead Sponsor: Cairo University

Brief Summary

obese male usually complain subjective tinnitus that may affect their sexual function.

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 Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-06
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-04-06
• Study Completion: 2025-04-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
international index of erectile function	it will be assessed after 12 weeks	Arabic form that contain five question will be used

Secondary Outcome Measures

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

Trial Locations

Locations (1)

faculty of physical therapy Cairo university; 🇪🇬 Dokki, Giza, Egypt