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Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

NCT ID: NCT06716125

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2025-04-06

Brief Summary

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

Detailed Description

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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).

Conditions

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Obesity Tinnitus, Subjective Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

aerobic treadmill walking plus low calorie diet

Intervention Type BEHAVIORAL

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).

Group II

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Group Type ACTIVE_COMPARATOR

low calorie diet

Intervention Type BEHAVIORAL

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Interventions

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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).

Intervention Type BEHAVIORAL

low calorie diet

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Isamil, Lecturer

Role: CONTACT

Phone: 0201005154209

Email: [email protected]

ahmed elfahl, Lecturer

Role: CONTACT

Phone: 0201001891218

Email: [email protected]

Facility Contacts

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Ali MA Ismail, lecturer

Role: primary

ahmed elfahl, lecturer

Role: backup

Other Identifiers

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IRB00014233-16

Identifier Type: -

Identifier Source: org_study_id