跳至主要内容
临床试验/NCT06721429
NCT06721429已完成不适用

The Effect of Dual-task Training on Balance, Exercise Capacity, Cognitive Status, and Quality of Life in Individuals With Type 2 Diabetes Mellitus

Bartın Unıversity1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Time Up and Go Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Combined Exercise Training Group

Active Comparator

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.

干预措施: Combined Exercise Training Group (Other)

dual task exercise group

Experimental

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.

干预措施: dual task exercise group (Other)

control group

No Intervention

Participants in the control group will be instructed to continue their usual daily activities without participating in a structured exercise training program during the eight-week study period. They will receive standardized education on physical activity, blood glucose self-monitoring, and reducing sedentary behavior, with weekly telephone contact. After the final assessment, participants will be invited to join an exercise training program of their choice.

结局指标

主要结局

Time Up and Go Test

时间窗: Baseline and immediately after the eight-week intervention.

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.

次要结局

  • Functional exercise capacity Functional Exercise Capacity(Baseline and immediately after the eight-week intervention.)
  • Timed Up and Go Test (Cognitive)(Baseline and immediately after the eight-week intervention.)
  • Montreal Cognitive Assessment (MoCA)(Baseline and immediately after the eight-week intervention.)
  • Stroop Test(Baseline and immediately after the eight-week intervention.)
  • Diabetes-specific Quality of Life Scale (ADDQoL)(Baseline and immediately after the eight-week intervention.)
  • Processing Speed(Baseline and immediately after the eight-week intervention.)
  • Biochemical Analysis(Baseline and immediately after the eight-week intervention.)

研究者

发起方
Bartın Unıversity
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gizem Mermerkaya

lecturer

Bartın Unıversity

研究点 (1)

Loading locations...

相似试验