Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus

Not Applicable

Recruiting

• Conditions: Tinnitus; Metabolic Syndrome X; Obesity; Elderly; Weight Loss

• Registration Number: NCT06702085
• Lead Sponsor: Cairo University

Brief Summary

The problem of tinnitus (subjective type) is prevalent in obese older adults with different diseases such as metabolic syndrome. The changes of lifestyle are very important to lose weight, improve tinnitus and metabolic syndrome

Detailed Description

Sixty older adults (with metabolic syndrome with chronic subjective tinnitus) with obesity were selected in a equal random manner to be classified into the first group that administered changes in their lifestyle (exercise applied on treadmill and low caloric diet) for twelve successive weeks and second group that was not administered lifestyle changes

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• obese person (class one obesity)
• patients with metabolic syndrome
• patients with chronic subjective tinnitus (bilateral complaint from more than six months).
• older adults aging 65 years and more
• both sexes will be included

Exclusion Criteria

• respiratory insult
• cardiac insult
• liver insult
• kidney insult
• lower limb insult
• neurological insult

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
visual analogue scale of tinnitus severity	twelve weeks	it is scale (10 cm) that will assess severity of tinnitus

Secondary Outcome Measures

Name	Time	Method
visual analogue scale of tinnitus related discomfort	twelve weeks	it is a scale (10 cm) that will assess tinnitus related discomfort
tinnitus handicap inventory	twelve weeks	it is a questionnaire that will assess quality of life in tinnitus population
body mass index	twelve weeks	it will be assessed at morning after evacuation of bowel and bladder
waist circumference	twelve weeks	it will be measured at the level of umbilicus
triglycerides	twelve weeks	it will be measured in the serum
high density lipoprotein	twelve weeks	it will be assessed in the serum
systolic blood pressure	twelve weeks	it will be assessed by mercury sphygmomnameter
diastolic blood pressure	twelve weeks	it will be assessed by mercury sphygmomnameter
fasting blood glucose	twelve weeks	it will be measured in serum

Trial Locations

Locations (2)

Cairo University; 🇪🇬 Dokki, Giza, Egypt

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