The aim of this randomized controlled study is to investigate the effects of dual-task training on functional mobility, exercise capacity, cognitive function, and quality of life in adults aged 65 years and older with type 2 diabetes mellitus. Changes in serum brain-derived neurotrophic factor (BDNF) levels will also be assessed as a secondary outcome. The study will compare three groups: dual-task training, combined exercise training, and a control group. Both exercise groups will receive aerobic, resistance, and balance training three times per week for eight weeks. In the dual-task group, participants will perform cognitive tasks targeting memory, verbal fluency, executive function, calculation, and attention concurrently with the physical exercises. The combined exercise group will perform the physical exercises without concurrent cognitive tasks. The main research question is whether adding simultaneous cognitive tasks to combined exercise training provides additional benefits for functional mobility, assessed using the Timed Up and Go test. The study will also examine effects on exercise capacity, cognitive function, dual-task performance, quality of life, and serum BDNF levels. Outcomes will be compared across the three groups.
Older adults with type 2 diabetes mellitus (T2DM) may experience balance, gait, and cognitive impairments. T2DM is associated with an increased risk of cognitive decline and dementia in older adults. Factors such as insulin resistance, impaired glucose metabolism, advanced glycation end-products, impaired amyloid beta clearance, oxidative stress, and inflammation may contribute to these changes. T2DM has been linked to impairments in episodic memory, verbal fluency, working memory, processing speed, and executive functions. Executive functions are higher-level processes that oversee and regulate other cognitive functions. These capabilities support planning, decision-making, switching between tasks, goal-directed behavior, and coordinating simultaneous activities. Executive function also contributes to the integration of sensory information required for balance and gait. Impairments in these functions may therefore compromise functional mobility and increase fall risk in older adults with T2DM. Dual-task paradigms are used to examine performance when two tasks are undertaken simultaneously. A primary motor task, such as walking, is combined with a secondary task, and the effects on performance are evaluated. Everyday activities, such as walking while talking, frequently involve these simultaneous demands. When the combined demands of the tasks exceed available attentional resources, performance on one or both tasks may deteriorate. Executive dysfunction may increase this interference. Dual tasks can involve motor-cognitive, cognitive-cognitive, or motor-motor combinations. Previous research has reported adverse effects of dual-task conditions on gait parameters in individuals with T2DM. These findings highlight the importance of considering the interaction between cognitive abilities and motor skills when planning rehabilitation programs. The effects of dual-task training on balance and cognitive function have been investigated in other populations at increased risk of falls, including stroke survivors, individuals with Parkinson's disease, and older adults with a history of falls. Because cognitive processes contribute to balance and mobility, evaluating physical performance together with cognitive function may provide a more comprehensive understanding of the effects of dual-task training. Previous studies have reported improvements in balance and executive function following dual-task training in older adults. Combined aerobic and resistance exercise has also shown potential benefits for cognition in individuals with T2DM. However, whether adding concurrent cognitive tasks to a combined exercise program provides additional benefits in older adults with T2DM remains unclear. Brain-derived neurotrophic factor (BDNF) is involved in synaptic plasticity and may provide a biological link between exercise and cognitive function. Nevertheless, reported BDNF responses to exercise in individuals with T2DM have been variable. Assessing serum BDNF alongside functional and cognitive outcomes may help characterize the responses to combined physical and cognitive training, although serum measurements alone cannot establish changes in brain function. This three-arm randomized controlled study will investigate the effects of dual-task training compared with combined exercise training and a control condition in adults aged 65 years and older with T2DM. Participants will be randomly assigned to the dual-task training group, the combined exercise training group, or the control group. Both exercise groups will undergo aerobic, resistance, and balance training three times per week for eight weeks. The dual-task group will perform the same physical exercise program with concurrent cognitive tasks targeting memory, verbal fluency, executive function, mental arithmetic, and divided attention. The combined exercise group will perform the physical exercises without concurrent cognitive tasks. The control group will receive standardized education on physical activity, glycemic self-monitoring, and reducing sedentary behavior, with weekly telephone contact. The study will examine whether adding concurrent cognitive tasks to combined exercise training provides additional benefits for functional mobility, assessed using the Timed Up and Go test. Exercise capacity, global cognitive function, executive function, reaction time, dual-task mobility and cost, diabetes-specific quality of life, and serum BDNF levels will also be evaluated before and after the intervention. The study aims to clarify the potential contribution of concurrent cognitive training to rehabilitation in older adults with T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Dual task exercise group Patients in the dual-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training. In addition, cognitive exercise training will be incorporated into each session, performed concurrently with the conventional physiotherapy. The cognitive exercises provided in this study are structured to target areas such as memory, verbal fluency, executive functions, calculation, and attentioN Single task exercise group Patients in the single-task training group will undergo 60-minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.
Combined Exercise Training Group Patients in the single-task training group will undergo 60-75 minute conventional physiotherapy sessions three times a week for 8 weeks. Each physiotherapy session will consist of aerobic exercise, strengthening exercises, and balance training.
Bartın University
Bartın, Bartın, Turkey (Türkiye)
Time Up and Go Test
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
Time frame: Baseline and immediately after the eight-week intervention.
Functional exercise capacity Functional Exercise Capacity
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT). The participants will be instructed to walk at their maximum comfortable pace for 6 minutes along a 30-meter long, flat, and uninterrupted corridor. At the end of the test, the endpoint will be marked, and the total distance walked will be calculated.
Time frame: Baseline and immediately after the eight-week intervention.
Timed Up and Go Test (Cognitive)
Participants will be asked to perform both the single-task and cognitive dual-task versions of the Timed Up and Go (TUG) test. In the single-task condition, participants will complete the TUG test without any secondary task. In the cognitive dual-task condition, participants will perform the TUG test while also engaging in a cognitive task, specifically subtracting 3 from 100 repeatedly during the walk.
Time frame: Baseline and immediately after the eight-week intervention.
Montreal Cognitive Assessment (MoCA)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a reliable assessment tool that is particularly effective in testing cognitive levels in individuals with mild cognitive impairment and Alzheimer's disease. It is designed to evaluate various cognitive domains, including attention, memory, language, visuospatial abilities, executive functions, and orientation, providing a comprehensive measure of cognitive health. This tool is widely used in clinical settings for early detection and monitoring of cognitive decline.
Time frame: Baseline and immediately after the eight-week intervention.
Stroop Test
The Stroop Test is a widely used psychological test to assess cognitive flexibility, selective attention, and the ability to inhibit cognitive interference. The test is based on the Stroop Effect, which refers to the delay in reaction time when the name of a color is written in a different color ink.
Time frame: Baseline and immediately after the eight-week intervention.
Diabetes-specific Quality of Life Scale (ADDQoL)
Diabetes-specific quality of life will be assessed using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire. Two global items and the average weighted impact score will be evaluated to assess the perceived impact of diabetes on quality of life.
Time frame: Baseline and immediately after the eight-week intervention.
Processing Speed
The processing speed will be evaluated by measuring the reaction time. To measure the reaction time, a FitLight Trainer (Fitlight Sports Corp., Canada) will be used. The FitLight Trainer is primarily used for training purposes and is also suitable for use with older individuals.
Time frame: Baseline and immediately after the eight-week intervention.
Biochemical Analysis
Baseline HbA1c levels will be reported to characterize glycemic status. Serum BDNF levels will be assessed before and after the eight-week intervention.
Time frame: Baseline and immediately after the eight-week intervention.
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