Clinical trial NCT06721429: The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life
Official title: The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: exercise
balance
exercise tolerance
Mental Status
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will include 36 patients with type 2 diabetes mellitus. Patients who meet the inclusion criteria will be randomly assigned to one of three groups: the dual-task exercise training group (n=12), the single-task exercise training group (n=12), or the control group (n=12).In the single-task exercise training group, aerobic exercise, resistance training, and balance training will be performed as separate tasks, while in the dual-task training group, these same exercises will be performed simultaneously with cognitive dual-task training. The control group will be instructed to continue with their daily activities and refrain from participating in any exercise training program for eight weeks after the initial assessment. In the exercise training groups, individuals will undergo a combined exercise program consisting of aerobic exercise, resistance training, and balance training, with three sessions per week on non-consecutive days over a period of 8 weeks, totaling 24 sessions.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of dual-task training on balance, exercise capacity, cognitive function, and quality of life in individuals with Type 2 Diabetes Mellitus (DM). As a result of this study, it is hoped that dual-task training will be an alternative to single-task training in the rehabilitation of individuals with Type 2 DM, with the goal of preventing falls and supporting a more active lifestyle. Additionally, it is intended to include dual-task training in preventive physiotherapy approaches. The main questions the study aims to answer are as follows:

Is dual-task training, conducted concurrently with exercise training, more effective in improving balance when compared to exercise training alone and the control group?

Is dual-task training, conducted concurrently with exercise training, more effective in improving exercise capacity, cognitive function, and quality of life when compared to exercise training alone and the control group?

The researchers will compare the effects of dual-task training in individuals with Type 2 diabetes by comparing the participants in the single-task exercise training group and the control group. Participants will be randomized into the dual-task exercise training group, the single-task exercise training group, and the control group. Individuals in the training group will undergo exercise training three days a week for 8 weeks.

Detailed description: Geriatric individuals with Type 2 DM experience balance, gait, and cognitive impairments. Type 2 DM has been found to be associated with a 1.5 to 2.5-fold increased risk of dementia in the elderly population. In individuals with Type 2 DM, cognitive decline risk is heightened due to factors such as insulin resistance, impaired glucose metabolism, advanced glycation end-products, impaired amyloid beta degradation, increased oxidative stress, and inflammation. Among adults with Type 2 DM, the global prevalence of cognitive impairment is approximately 45%, with rates varying between 21.8% and 67.5% in different countries. Type 2 DM is most commonly linked to declines in episodic memory, verbal fluency, working memory, processing speed, and executive functions. Executive functions are "higher-level" processes that oversee and control other cognitive functions. These capabilities underpin activities such as planning, decision-making, switching between tasks, goal-directed behavior, and coordinating ongoing activities (e.g., multitasking or planning a series of activities). More importantly, executive function is critical for sensory integration used to coordinate balance and gait motor output. Declines in executive function serve as a risk factor for falls in geriatric individuals with DM. Dual-task paradigms are used to examine the degree of automaticity of movement. In these paradigms, a primary task, often walking, is undertaken with the main focus on attention. Secondary tasks are added, and the effects on both tasks are evaluated. In everyday situations, such as walking and talking, it is common to perform multiple tasks simultaneously, thus these situations are essentially dual-task paradigms. When the combined load of two or more tasks exceeds available attention capacity, performance on one or both tasks will deteriorate. Impairments in executive function lead to the emergence of dual-task paradigms. These tasks can be motor-cognitive, cognitive-cognitive, or motor-motor. A previous study observed a negative impact of dual-tasking on gait parameters in individuals with Type 2 DM. This suggests that impaired dual-task capacity in Type 2 DM may contribute to the higher incidence of falls in this population. This highlights the need for training that develops the relationship between cognitive abilities and motor skills when planning rehabilitation programs. In studies conducted on other high-fall-risk groups (stroke survivors, Parkinson's disease, and elderly individuals with a fall history), the effects of dual-task training on balance have been described. Improvements in balance were explained by physical parameters such as gait speed and step length. However, since cognitive factors significantly influence balance, in addition to physical components, it is necessary to investigate the underlying cognitive functions of balance following dual-task training. In a study of elderly adults with a history of falls, it was shown that dual-task training was effective in improving both balance and executive function. It is believed that improvements in executive function in elderly individuals may be an effective way to enhance balance. A 2023 meta-analysis showed that combined exercise training (aerobic + resistance) improved cognitive function, particularly executive function, in individuals with Type 2 DM. Studies conducted on healthy adults have demonstrated that participation in simultaneous combined exercise and cognitive training (dual-task training) improves cognition beyond the effects of the individual components. These combined effects may have an additional impact on brain and physiological functions. While many studies in the literature have shown the positive effects of combined exercise on executive function in Type 2 DM, there are few studies investigating whether dual-task training, which has shown positive effects in other populations, is more effective in improving balance and executive function in individuals with Type 2 DM. A 2018 study demonstrated that step training exercises were feasible and improved executive function in adults with Type 2 DM and cognitive complaints. However, the effect of dual-task training combined with aerobic, strength, and balance exercises in individuals with Type 2 DM has not been previously investigated.

The aim of this study is to investigate the effects of dual-task training on balance, exercise capacity, cognitive function, and quality of life in individuals with Type 2 DM. This project will focus on dual-task training in geriatric individuals with Type 2 DM. The effects of cognitive exercises combined with exercise training will be compared with combined exercise training alone, focusing on balance, aerobic capacity, cognitive function, and quality of life. One of the complications in geriatric individuals with Type 2 DM is the decline in dual-task performance, which leads to deviations in normal gait, difficulties in maintaining balance, and ultimately mobility restrictions. It is expected that dual-task training will enhance dual-task performance more than single-task training. Investigators anticipate that this improvement in performance will allow geriatric individuals to spend more independent time in daily activities, enhance their balance, and improve their quality of life. Unlike conventional physiotherapy approaches, dual-task training aims to improve both motor and cognitive performance simultaneously, thus saving time. It is expected that participation in different and engaging exercise training will increase exercise participation (sustainability) in the short and/or long term. Investigators expect that dual-task training in geriatric individuals with Type 2 DM will improve cognitive performance, contribute to functional capacity, and prevent falls.

Eligibility criteria: Inclusion Criteria:

* Being followed up with a diagnosis of Type 2 Diabetes Mellitus for at least 6 months (fasting plasma glucose of 7.0 mmol/L or higher)
* Not having participated in any structured exercise program for at least 6 months prior.
* Being willing to volunteer for the study

Exclusion Criteria:

* Nephropathy
* Retinopathy
* Having dementia or Alzheimer's disease
* Using a walking aid
* Having ulceration
* Using balance-curing drugs
* Surviving myocardial infarction at least 6 months ago
* Stable or unstable angina pectoris
* Left ventricular ejection fraction below 40%
* Peripheral arterial diseases
* Resting blood pressure above 160/100 mmHg
* Body mass index above 35 kg/m2
* Having a history of deep vein thrombosis, pulmonary embolism or stroke in the past

Primary outcomes:
measure: Time Up and Go Test
timeFrame: In 2 weeks
measure: Berg Balance Scale
timeFrame: In 2 weeks
Secondary outcomes:
measure: Functional Reaching Test
timeFrame: In 2 weeks
measure: Single-Leg Stance Test
timeFrame: In 2 weeks
measure: Maximal exercise test
timeFrame: In 2 weeks
measure: Functional exercise capacity Functional Exercise Capacity
timeFrame: In 2 weeks
measure: Timed Up and Go Test (Cognitive)
timeFrame: In 2 weeks
measure: Timed Up and Down Test (Standard-Cognitive)
timeFrame: In 2 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: In 2 weeks
measure: Stroop Test
timeFrame: In 2 weeks
measure: Diabetes-specific Quality of Life Scale (DQoL)
timeFrame: In 2 weeks
measure: Processing Speed
timeFrame: In 2 weeks
measure: Muscle Strength
timeFrame: In 2 weeks
measure: Pittsburgh Sleep Quality Index: PUKI
timeFrame: In 2 weeks
measure: Geriatric Depression Scale (GDS)
timeFrame: In 2 weeks
measure: Activity-Specific Balance Confidence
timeFrame: In 2 weeks
measure: Biochemical Analysis
timeFrame: In 2 weeks
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın University
Study officials:
affiliation: Bartın Unıversity
name: gizem mermerkaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villafaina S, Collado-Mateo D, Dominguez-Munoz FJ, Fuentes-Garcia JP, Gusi N. Impact of adding a cognitive task while performing physical fitness tests in women with fibromyalgia: A cross-sectional descriptive study. Medicine (Baltimore). 2018 Dec;97(51):e13791. doi: 10.1097/MD.0000000000013791.
citation: Shellington EM, Reichert SM, Heath M, Gill DP, Shigematsu R, Petrella RJ. Results From a Feasibility Study of Square-Stepping Exercise in Older Adults With Type 2 Diabetes and Self-Reported Cognitive Complaints to Improve Global Cognitive Functioning. Can J Diabetes. 2018 Dec;42(6):603-612.e1. doi: 10.1016/j.jcjd.2018.02.003. Epub 2018 Mar 6.
citation: Beauchet O, Dubost V, Aminian K, Gonthier R, Kressig RW. Dual-task-related gait changes in the elderly: does the type of cognitive task matter? J Mot Behav. 2005 Jul;37(4):259-64.
citation: Tard C, Dujardin K, Girard A, Debaughrien M, Derambure P, Defebvre L, Delval A. How does visuospatial attention modulate motor preparation during gait initiation? Exp Brain Res. 2016 Jan;234(1):39-50. doi: 10.1007/s00221-015-4436-0. Epub 2015 Sep 10.
citation: Park JH. Is Dual-Task Training Clinically Beneficial to Improve Balance and Executive Function in Community-Dwelling Older Adults with a History of Falls? Int J Environ Res Public Health. 2022 Aug 17;19(16):10198. doi: 10.3390/ijerph191610198.
citation: Zhang J, Tam WWS, Hounsri K, Kusuyama J, Wu VX. Effectiveness of Combined Aerobic and Resistance Exercise on Cognition, Metabolic Health, Physical Function, and Health-related Quality of Life in Middle-aged and Older Adults With Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Aug;105(8):1585-1599. doi: 10.1016/j.apmr.2023.10.005. Epub 2023 Oct 22.
citation: Callisaya ML, Daly RM, Sharman JE, Bruce D, Davis TME, Greenaway T, Nolan M, Beare R, Schultz MG, Phan T, Blizzard LC, Srikanth VK. Feasibility of a multi-modal exercise program on cognition in older adults with Type 2 diabetes - a pilot randomised controlled trial. BMC Geriatr. 2017 Oct 16;17(1):237. doi: 10.1186/s12877-017-0635-9.