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Clinical Trials/NCT06702085
NCT06702085RecruitingNot Applicable

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

Cairo University2 sites in 1 country60 target enrollmentStarted: January 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
2
Primary Endpoint
visual analogue scale of tinnitus severity

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 75 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

second group

No Intervention

thirty older adults (with obesity, metabolic syndrome, and chronic subjective tinnitus) served as control patients who did not receive any changes in their lifestyle

first group

Experimental

thirty older adults (with obesity, metabolic syndrome, and chronic subjective tinnitus) 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

Intervention: Lifestyle Management (Behavioral)

Outcomes

Primary Outcomes

visual analogue scale of tinnitus severity

Time Frame: twelve weeks

it is scale (10 cm) that will assess severity of tinnitus

Secondary Outcomes

  • visual analogue scale of tinnitus related discomfort(twelve weeks)
  • tinnitus handicap inventory(twelve weeks)
  • body mass index(twelve weeks)
  • waist circumference(twelve weeks)
  • triglycerides(twelve weeks)
  • high density lipoprotein(twelve weeks)
  • systolic blood pressure(twelve weeks)
  • diastolic blood pressure(twelve weeks)
  • fasting blood glucose(twelve weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Mohamed Ali ismail

lecturer, Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

Study Sites (2)

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