Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus

November 20, 2024 updated by: Ali Mohamed Ali ismail, Cairo University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt, 11432
      • Dokki, Giza, Egypt, 11432
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: first group
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
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
No Intervention: second group
thirty older adults (with obesity, metabolic syndrome, and chronic subjective tinnitus) served as control patients who did not receive any changes in their lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale of tinnitus severity
Time Frame: twelve weeks
it is scale (10 cm) that will assess severity of tinnitus
twelve weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali MA Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004623

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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