Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes

Bezmialem Vakif University

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Other: No intervention (observational study)

Study type: Observational

Funder types: Other

Identifiers

NCT07390292

2025/251

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Type 2 Diabetes Mellitus Group

Treatment:

Other: No intervention (observational study)

Healthy Control Group

Treatment:

Other: No intervention (observational study)