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Recruiting NCT06702085

Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus

No phase Interventional Tinnitus Metabolic Syndrome X Obesity Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lifestyle Management.
Who it may be relevant to
Registry conditions: Tinnitus, Metabolic Syndrome X, Obesity, Elderly. Basic parameters: 65 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Lifestyle Changes on Tinnitus in Older Adults With Metabolic Syndrome

Overview

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

Interventions

  • Behavioral Lifestyle Management
    patients administered supervised changes in their lifestyle (walking exercise for 40 minutes applied on treadmill for three time per week and low caloric diet) for twelve weeks

Primary outcome measures

  • visual analogue scale of tinnitus severity [Time frame: twelve weeks]
Secondary outcome measures (9)
  • visual analogue scale of tinnitus related discomfort [Time frame: twelve weeks]
  • tinnitus handicap inventory [Time frame: twelve weeks]
  • body mass index [Time frame: twelve weeks]
  • waist circumference [Time frame: twelve weeks]
  • triglycerides [Time frame: twelve weeks]
  • high density lipoprotein [Time frame: twelve weeks]
  • systolic blood pressure [Time frame: twelve weeks]
  • diastolic blood pressure [Time frame: twelve weeks]
  • fasting blood glucose [Time frame: twelve weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 2 centers
  • Cairo University — Dokki
  • faculty of physical therapy Cairo university — Dokki

Publications

  • Ismail AMA, Tolba AMN. Effectiveness of lifestyle-modification approach (a randomized-controlled program of diet restriction and treadmill walking exercise) on elderly's metabolic syndrome-associated subjective tinnitus. Eur Arch Otorhinolaryngol. 2025 Aug;282(8):4307-4315. doi: 10.1007/s00405-025-09494-7. Epub 2025 Jun 11. PMID 40500514

Identifiers

NCT: NCT06702085 · P.T.REC/012/004623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗