Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus

NCT ID: NCT06702085

Last Updated: 2024-11-22

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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

Conditions

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Tinnitus Metabolic Syndrome X Obesity Elderly Weight Loss

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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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

Group Type EXPERIMENTAL

Lifestyle Management

Intervention Type BEHAVIORAL

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

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

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali MA Ismail, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

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 MA Ismail, Lecturer

Role: CONTACT

+201005154209

Facility Contacts

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ali AM Ismail, lecturer

Role: primary

+201005154209

ahmed MN Tolba, lecturer

Role: backup

+2001001897666

Ali MA Ismail, lecturer

Role: primary

+201005154209

ahmed MN Tolba, lecturer

Role: backup

+201001897666 ext. +201001897666

References

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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.

Reference Type DERIVED
PMID: 40500514 (View on PubMed)

Other Identifiers

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P.T.REC/012/004623

Identifier Type: -

Identifier Source: org_study_id

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