Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention (observational study).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Cognitive Functions on Functional Capacity, Balance, Fear of Falling and Quality of Life in Patients With Type 2 Diabetes
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Postural Stability [Time frame: Single assessment at baseline]
- Limits of Stability [Time frame: Single assessment at baseline]
- Sensory Integration of Balance [Time frame: Single assessment at baseline]
Secondary outcome measures (12)
- Stroop Test [Time frame: Single assessment at baseline]
- Mini-Mental State Examination (MMSE) [Time frame: Single assessment at baseline]
- Four Square Step Test [Time frame: Single assessment at baseline]
- Assessment of Functional Capacity [Time frame: Single assessment at baseline]
- 30 Second Sit to Stand Test [Time frame: Single assessment at baseline]
- Quadriceps Femoris Muscle Strength [Time frame: Single assessment at baseline]
- Falls Efficacy Scale-International (FES-I) [Time frame: Single assessment at baseline]
- Functional Reach Test [Time frame: Single assessment at baseline]
- Timed Up and Go (TUG) Test [Time frame: Single assessment at baseline]
- Assessment of Quality of Life [Time frame: Single assessment at baseline]
- Body Mass İndex [Time frame: Single assessment at baseline]
- Body Fat Mass (kg) [Time frame: Single assessment at baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Bezmialem Vakif University — Istanbul
Identifiers
NCT: NCT07390292 · 2025/251