The Effect of Cognitive Functions on Functional Capacity, Balance, Fear of Falling and Quality of Life in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postural Stability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Type 2 Diabetes Mellitus Group
干预措施: No intervention (observational study) (Other)
Healthy Control Group
干预措施: No intervention (observational study) (Other)
结局指标
主要结局
Postural Stability
时间窗: Single assessment at baseline
Postural stability will be assessed using the Biodex Balance System®. This assessment is performed to evaluate the individual's ability to maintain the center of body mass. Deviations from the center of balance will be recorded during the test. Higher stability index scores indicate greater deviation from the center of balance and poorer postural stability.
Limits of Stability
时间窗: Single assessment at baseline
This assessment will be conducted using the Biodex Balance System®. The test will be performed on a static platform. The purpose of the test is to evaluate the individual's ability to shift and control the center of body mass within the base of support. Directional control (overall, forward, backward, left, right, forward/left, forward/right, backward/left, backward/right) will be assessed and expressed as a percentage (%). Higher scores are associated with better postural control.
Sensory Integration of Balance
时间窗: Single assessment at baseline
This assessment will be conducted using the Biodex Balance System®. The purpose of the test is to evaluate how different sensory inputs contribute to the maintenance of balance and how well balance can be preserved when one or more of these sensory inputs are removed. The test will be performed under the following conditions: eyes open and eyes closed on a firm surface, and eyes open and eyes closed on a foam surface. A sway index will be calculated for each condition.
次要结局
- Stroop Test(Single assessment at baseline)
- Mini-Mental State Examination (MMSE)(Single assessment at baseline)
- Four Square Step Test(Single assessment at baseline)
- Assessment of Functional Capacity(Single assessment at baseline)
- 30 Second Sit to Stand Test(Single assessment at baseline)
- Quadriceps Femoris Muscle Strength(Single assessment at baseline)
- Falls Efficacy Scale-International (FES-I)(Single assessment at baseline)
- Functional Reach Test(Single assessment at baseline)
- Timed Up and Go (TUG) Test(Single assessment at baseline)
- Assessment of Quality of Life(Single assessment at baseline)
- Body Mass İndex(Single assessment at baseline)
- Body Fat Mass (kg)(Single assessment at baseline)
- Skeletal Muscle Mass (kg)(Single assessment at baseline)
- Resting Metabolic Rate(Single assessment at baseline)
- Visceral Fat Level(Single assessment at baseline)