Clinical trial NCT06819371: Impact of Dual vs. Single Task Exercise on Cognitive Function, Balance, and Functionality in Type 2 Diabetes
Official title: Effects of Dual Task and Single Task Exercise Training on Cognitive Performance, Balance and Functionality in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Dual task
Cognitive Function
Balance
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: Diabetes Mellitus is defined as a carbohydrate mechanism disorder in which glucose cannot be used as an adequate energy source and is produced excessively, causing hyperglycemia. For the diagnosis of diabetes, an increase in HbA1c in the blood or a high glucose concentration in venous plasma is examined. Although there are various clinical subtypes, Type 2 diabetes constitutes 90% of the approximately 537 million diabetics worldwide. In the treatment of diabetes, there are pharmacological treatments and lifestyle changes to ensure glycemic control. The most important lifestyle change interventions are balanced calorie intake, increased physical activity and regular exercise.

The effect of exercise on complications associated with Type 2 diabetes, such as improving glycemic control, reducing inflammation and reducing cardiovascular risk, is clear and it is known that these also affect cognition.

In this context, dual-task exercises that can target both the improvement of parameters related to postural control and balance as a physical development and the development of cognitive functions are gaining importance. The aim of dual-task exercises is to direct the person's attention to another source while the first task is being performed. When the literature is examined, there are separate studies on the effects of dual-task exercises on both balance and walking performance and cognitive functions. However, the meta-analyses conducted on these studies emphasize the need for more newly designed studies. Therefore, our study aims to examine the effects of dual-task exercise training, which includes both physical and cognitive parameters, on cognitive functions, balance and functionality in individuals with type 2 diabetes. Patients who applied to the Artvin State Hospital Internal Medicine polyclinic and were diagnosed with type 2 diabetes and who meet the inclusion and exclusion criteria will be included in our study. The patients included in the study will be divided into 3 groups: dual-task exercise group, single-task exercise group and control group. Both intervention groups will be included in an exercise program with a physiotherapist 2 days a week for 8 weeks in addition to their medical treatments. The control group will be recommended walking only in addition to their medical treatment during these 8 weeks. All 3 groups will be evaluated twice, at the beginning of the study and at the end of the 8th week.

Detailed description: Diabetes Mellitus is defined as a carbohydrate mechanism disorder in which glucose cannot be used as an adequate energy source and is overproduced, causing hyperglycemia. Diabetes is diagnosed by an increase in HbA1c in the blood or a high glucose concentration in venous plasma. Although there are various clinical subtypes, Type 2 diabetes accounts for 90% of the approximately 537 million diabetics worldwide. In the treatment of diabetes, there are pharmacological treatments and lifestyle changes to achieve glycemic control. The most important lifestyle change interventions are balanced calorie intake, increased physical activity and regular exercise.

The effect of exercise on complications associated with Type 2 diabetes, such as improving glycemic control, reducing inflammation and reducing cardiovascular risk, is clear and is known to affect cognitive functions.

Loss of postural balance is a significant problem frequently observed in patients with T2DM. Balance is defined as the individual's capacity to maintain or regulate the center of mass within the limits of balance. In this process, the integration of physiological systems including motor, sensory and dynamic control systems, vestibular, visual and proprioceptive mechanisms, muscle strength and reaction times plays a critical role. Although balance dysfunctions are generally attributed to diabetic peripheral neuropathy (DPN), balance disorders are also observed in individuals without DPN. Impaired balance function increases the risk of falling, especially in elderly T2DM patients.

However, an important problem that is frequently observed in T2DM patients but can be neglected is cognitive dysfunction. Cognitive dysfunction is a broad concept that encompasses deficiencies in various areas such as attention, memory, executive functions, language and spatial skills. Diabetes and cognitive dysfunction are chronic conditions that are frequently seen together, especially in elderly individuals, and when evaluated together, they significantly increase the risk of morbidity and mortality. Cognitive impairment can lead to serious difficulties in meeting the self-care needs of diabetic individuals and maintaining their economic and social independence. On the other hand, inadequate management of diabetes can also increase the risk of cognitive dysfunction and cause this situation to worsen.

In this context, dual-task exercises that can target both the improvement of parameters related to postural control and balance as physical development and the development of cognitive functions are gaining importance. Therefore, our study aims to examine the effects of dual-task exercise training, which includes both physical and cognitive parameters, on cognitive functions, balance and functionality in individuals with type 2 diabetes.

Patients who apply to the Artvin State Hospital Internal Medicine polyclinic and are diagnosed with type 2 diabetes and meet the inclusion and exclusion criteria will be included in our study. The patients included in the study will be divided into 3 groups: dual-task exercise group, single-task exercise group and control group.

Each of the 3 groups will be evaluated twice, at the beginning of the study and at the end of the 8th week.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with T2DM,
* Being between the ages of 40-65,
* Being able to walk independently,
* Being willing to exercise at least 2 days a week in the intervention groups as required by the research,
* Not having cooperation and communication problems,
* Not having participated in a regular exercise program in the last 6 months.

Exclusion Criteria:

* Patients who do not volunteer to participate in the study
* Patients with complications such as diabetes-related nephropathy, neuropathy, retinopathy
* Patients with orthopedic, neurological, surgical problems that prevent them from walking and exercising
* Patients with cardiac, pulmonary, or systemic diseases that prevent them from exercising
* Patients with vision problems that cannot be corrected with glasses or lenses
* Patients with hearing loss that cannot be corrected with hearing aids

Primary outcomes:
measure: Timed get-up-and-go test (TUG)
timeFrame: At baseline and after 8 weeks
measure: Four-step Square Test (FSST)
timeFrame: At baseline and after 8 weeks
measure: Balance Error Scorring System (BESS)
timeFrame: At baseline and after 8 weeks
measure: Functional Reach Test (FRT)
timeFrame: At baseline and after 8 weeks
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: At baseline and after 8 weeks
measure: Scoring Range
timeFrame: At baseline and after 8 weeks
measure: Stroop Test
timeFrame: At baseline and after 8 weeks
measure: The Controlled Oral Word Association Test
timeFrame: At baseline and after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: Sidrenur Aslan Kolukısa, MSc Pt
role: STUDY_DIRECTOR
References: