Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: No intervention (observational study).
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes. Базовые параметры: 40 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Cognitive Functions on Functional Capacity, Balance, Fear of Falling and Quality of Life in Patients With Type 2 Diabetes
Обзор
Diabetes is a chronic metabolic disease that is becoming a growing public health problem worldwide, affecting people's lives in many ways. It is characterized by impaired carbohydrate, lipid, and protein metabolism associated with insufficient insulin secretion and/or reduced sensitivity to the metabolic effects of insulin.Along with diabetes, many complications may develop in affected individuals. Cognitive impairments are now also considered an important and common complication of diabetes.The aim of this study is to investigate the effects of cognitive function levels on functional capacity, balance, fear of falling, and quality of life in individuals with type 2 diabetes.In this context, participants' cognitive function levels will be assessed using the Mini-Mental State Examination and the Stroop Test. Functional capacity will be evaluated using the 6-Minute Walk Test. Balance performance will be assessed using the Biodex Balance System and the Four Square Step Test. Lower extremity muscle strength will be measured using a digital hand-held dynamometer and the 30-Second Sit-to-Stand Test. Fear of falling will be evaluated using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life will be assessed using the WHOQOL-BREF quality of life questionnaire.
Подробное описание
The study will include 40 volunteer patients diagnosed with Type 2 Diabetes Mellitus and a control group consisting of 40 healthy individuals without any chronic disease, matched in terms of age and sex. The research will be conducted at the Cardiac and Pulmonary Physiotherapy and Physiotherapy and Rehabilitation Education and Research Laboratory of Bezmialem Vakıf University Eyüp Campus. This study is designed as a cross-sectional study based on the objective evaluation of the current condition without any intervention or treatment.
Written informed consent will be obtained from all participants prior to participation. Subsequently, the demographic and clinical data of the participants will be recorded. Cognitive functions will be assessed using the Mini-Mental State Examination (MMSE) and the Stroop Test. Body composition will be measured using the digital and portable Omron BF511 Body Composition Monitor. Lower extremity muscle strength will be evaluated using an electronic hand-held dynamometer, and in addition, the 30-Second Sit-to-Stand Test will be performed.
Balance performance will be assessed using the Biodex Balance System; within this system, the Postural Stability Test, Limits of Stability Test, and Sensory Organization Test will be performed. In addition, the Four Square Step Test will also be conducted as a measure to support the assessment of dynamic balance.
Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life levels will be determined using the WHOQOL-BREF Quality of Life Questionnaire. All obtained results will be compared between individuals with type 2 diabetes and the healthy control group; the relationships between cognitive function levels and functional capacity, balance, fear of falling, and quality of life will be examined using statistical analyses.
The implementation of all assessments takes approximately 40-45 minutes for each participant.
Statistical analysis of the data will be performed using SPSS v.20 software, and a significance level of p\<0.05 will be accepted.
Вмешательства
- Другое No intervention (observational study)
This is an observational study. No treatment was applied to the individuals. The study will evaluate the individuals' cognitive functions and functional capacities, balance, fear of falling, and quality of life.
Первичные конечные точки
- Postural Stability [Срок оценки: Single assessment at baseline]
- Limits of Stability [Срок оценки: Single assessment at baseline]
- Sensory Integration of Balance [Срок оценки: Single assessment at baseline]
Вторичные конечные точки (12)
- Stroop Test [Срок оценки: Single assessment at baseline]
- Mini-Mental State Examination (MMSE) [Срок оценки: Single assessment at baseline]
- Four Square Step Test [Срок оценки: Single assessment at baseline]
- Assessment of Functional Capacity [Срок оценки: Single assessment at baseline]
- 30 Second Sit to Stand Test [Срок оценки: Single assessment at baseline]
- Quadriceps Femoris Muscle Strength [Срок оценки: Single assessment at baseline]
- Falls Efficacy Scale-International (FES-I) [Срок оценки: Single assessment at baseline]
- Functional Reach Test [Срок оценки: Single assessment at baseline]
- Timed Up and Go (TUG) Test [Срок оценки: Single assessment at baseline]
- Assessment of Quality of Life [Срок оценки: Single assessment at baseline]
- Body Mass İndex [Срок оценки: Single assessment at baseline]
- Body Fat Mass (kg) [Срок оценки: Single assessment at baseline]
Критерии участия
Критерии включения
- Being between 40 and 65 years of age
- Having an HbA1c level between 6.5 and 11
- Having been diagnosed with diabetes for at least 1 year
- Scoring 24 or higher on the Mini-Mental State Examination
- Being able to walk independently without assistance
- Having provided voluntary participation and signed written informed consent
Критерии исключения
- Having a diagnosis of any neurological or psychiatric disorder (e.g., hemiplegia, Alzheimer's disease, Parkinson's disease)
- Having uncontrolled hypertension and/or uncontrolled cardiac arrhythmia
- Having vertigo or other vestibular system disorders
- Having major musculoskeletal disorders
- Having undergone percutaneous transluminal coronary angioplasty or having a cardiac pacemaker
- Being pregnant
- Being unable to read or write in Turkish
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Turkey (Türkiye) · 1 центр
- Bezmialem Vakif University — Istanbul
Идентификаторы
NCT: NCT07390292 · 2025/251