跳至主要内容
临床试验/NCT06702085
NCT06702085招募中不适用

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

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
visual analogue scale of tinnitus severity

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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

干预措施: Lifestyle Management (Behavioral)

结局指标

主要结局

visual analogue scale of tinnitus severity

时间窗: twelve weeks

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

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

Cairo University

研究点 (2)

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