The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life

NCT ID: NCT06721429

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-25
• Study Completion Date: 2025-05-28

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

exercise; balance; exercise tolerance; Mental Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dual task exercise group

Patients in the dual-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. 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.

Group Type: EXPERIMENTAL

dual task exercise group

Intervention Type: OTHER

Dual task exercise group Patients in the dual-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. 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.

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.

Group Type: ACTIVE_COMPARATOR

single task group

Intervention Type: OTHER

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.

control group

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. After the exercise training period, the control group will also be invited to join the exercise training program of their choice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dual task exercise group

Dual task exercise group Patients in the dual-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. 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.

Intervention Type: OTHER

single task group

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Bartın Unıversity

OTHER

Sponsor Role: lead

Responsible Party

Gizem Mermerkaya

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

gizem mermerkaya

Role: PRINCIPAL_INVESTIGATOR

Bartın Unıversity

Locations

Bartın University

Bartın, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

gizem mermerkaya

Role: CONTACT

Phone: +905455850238

Email: gizmyagiz@gmail.com

gizem mermerkaya

Role: CONTACT

Email: gizmyagiz@gmail.com

Facility Contacts

gizem mermerkaya, MsC

Role: primary

References

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Reference Type: BACKGROUND

PMID: 30572536 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29884522 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15967751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26358126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36011833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37875170 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29037162 (View on PubMed)

Other Identifiers

BARU-FTR-GM-02

Identifier Type: -

Identifier Source: org_study_id