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临床试验/NCT06578091
NCT06578091招募中不适用

Effects of Executive Dysfunction on Physical Performance and General Well-Being in Obese Individuals

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Executive function

研究概览

简要总结

This study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • For the study group;
  • Individuals volunteering for the study with BMI ≥30 kg/m2
  • Individuals between the ages of 18-65 who volunteer to work
  • Individuals who scored 21 points and above in the cognitive assessment
  • For the control group;
  • Individuals volunteering for the study with BMI ≥30 kg/m2
  • Individuals between the ages of 18 and 65 who are willing to work
  • Scoring less than 21 points on the cognitive assessment

排除标准

  • Being at a mental level that cannot understand and answer the questions posed
  • Having a diagnosed neurological disease
  • Having had cancer within the last 2 years
  • Having major organ dysfunction
  • Having uncontrolled type 2 diabetes
  • Loss of vision, hearing

研究组 & 干预措施

Executive Function Deficit Group

Control Group

结局指标

主要结局

Executive function

时间窗: Baseline

It will be assessed with the Montreal Cognitive Assessment. Accordingly, a score of 21 points and above is considered normal. Individuals who score 21 points or less on this test will be included in the executive function deficit group. The others will included in control group.

General Well-Being-Sleep Quality

时间窗: Baseline

Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. The scale consists of 18 questions and 7 components and was developed to assess sleep disturbances and sleep quality in the last 1 month. These components include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. For scoring, it is applied as 0 if it has never occurred during the last month, 1 if it occurs less than once a week, 2 if it occurs once or twice a week, and 3 if it occurs three or more times a week. The total score has a value between 0-21. If the total score obtained as a result of the questionnaire is above 5, sleep quality is clinically poor.

General Well-Being-Quality of Life

时间窗: Baseline

Quality of life, sleep quality and depression levels will be assessed. Quality of life will be assessed with the 12-item Short Health Scale. Short Health Scale consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). Items related to physical and emotional role are answered as yes or no, while other items have Likert-type options ranging from 3 to 6. A higher score represents better health.

Physical Performance-Timed Up and Go

时间窗: Baseline

The timed up and go test is a functional dynamic balance test. The Timed Up and Go test is a timed measurement in which the individual has to get up from a chair, walk 3 meters, turn around, walk back and sit down. The Timed Up and Go is used to assess functional mobility and dynamic balance control in older people to identify increased risk of falls. Participants will be asked to wear the shoes they regularly wear to walk at a normal pace and will be allowed walking aids. The time between the participants getting up from the chair and sitting down again will be recorded in seconds.

General Well-Being-Depression and Anxiety

时间窗: Baseline

Depression and anxiety level will be assessed with the Hospital Depression and Anxiety Scale. It consists of 14 items. Seven of these items measure anxiety and the other seven items measure depression symptoms. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as not ill, 2 as borderline ill, and 2-3 as severely ill. Higher scores indicate more severe depression and anxiety.

Physical Performance-Hand Grip Strength

时间窗: Baseline

A digital Jamar dynamometer calibrated for hand grip strength (Performance Health, Warrenville, IL), Participants will be instructed to squeeze the dynamometer as hard as possible while sitting in an upright position as recommended by the American Association of Hand Therapists, with arms at their sides, elbows flexed 90° and forearms in a neutral position. A trial will be requested beforehand. For hand grip strength, 3 measurements will be made with one-minute intervals between each measurement and the average value will be recorded.

Physical Performance-Walking Speed

时间窗: Baseline

The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. A clear distance of at least 10 meters in length will be determined and marks will be added at 2 meters and 8 meters. Timing will start when the individual\'s toes cross the 2 meter mark. The person will be instructed to walk as fast as you can safely walk until I say stop. The timing will stop when the toes cross the 8 meter mark. Three trials will be performed and the average of the three trials will be taken.

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismail Okur

Assist. Prof.

Kutahya Health Sciences University

研究点 (2)

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