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临床试验/NCT05641090
NCT05641090招募中不适用

Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
Arterial stiffness

研究概览

简要总结

Nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes.

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
60 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.
  • Participants had Montreal Cognitive Assessment - Thai (MoCa-T) scores between 18 24 points.
  • Participants had time up & go test between 8 - 15 seconds

排除标准

  • Participants were excluded if they dropped out or completed less than 80% of the training schedule

结局指标

主要结局

Arterial stiffness

时间窗: Change from baseline brachial-ankle pulse wave velocity at 12 weeks.

Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare).

Cerebral blood flow

时间窗: Change from baseline cerebral blood flow at 12 weeks.

Cerebral blood flow in centimeter per second will be measured with ultrasonography equipment (EPIQ 5G, Phillips).

Pulsatility index

时间窗: Change from baseline Pulsatility index at 12 weeks.

Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips).

Mini-Mental State Examination

时间窗: Change from baseline Mini-Mental State Examination at 12 weeks.

Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.

Muscle mass and Weight

时间窗: Change from baseline muscle mass and weight at 12 weeks.

Muscle mass and weight in kilograms will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).

Heart rate

时间窗: Change from baseline heart rate at 12 weeks.

Heart rate in beats per minute will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).

ฺBody fat

时间窗: Change from baseline body fat at 12 weeks.

Body fat in percent will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare).

Macro vascular function

时间窗: Change from baseline brachial artery flow-mediated dilatation at 12 weeks.

Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment (EPIQ 5G, Phillips).

Cerebrovascular conductance index

时间窗: Change from baseline cerebrovascular conductance index at 12 weeks.

Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).

Montreal Cognitive Assessment

时间窗: Change from baseline Montreal Cognitive Assessment at 12 weeks.

Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function.

General physiological data

时间窗: Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks.

1.Blood pressure in mmHg will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap).

Cerebrovascular reactivity index

时间窗: Change from baseline cerebrovascular reactivity index at 12 weeks.

Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips).

Trail Making Test-B and Stroop test

时间窗: Change from baseline Trail Making Test-B and Stroop test at 12 weeks.

Trail Making Test-B in second cut off below 101 seconds that indicate dementia. Stroop test in second will be measured with EncephalApp Stroop test.

Arterial compliance

时间窗: Change from baseline Arterial compliance at 12 weeks.

Arterial compliance in units will be measure by carotid diameter during systolic and diastolic with ultrasonography equipment (EPIQ 5G, Phillips) and systemic blood pressure with (VP-1000 plus, omrom Healthcare).

次要结局

  • Cardiopulmonary fitness(Change from baseline 6-minutes walk at 12 weeks.)
  • Glycosylated hemoglobin(Change from baseline Glycosylated hemoglobin at 12 weeks.)
  • Fasting blood sugar(Change from baseline fasting blood sugar at 12 weeks.)
  • Lipid profile(Change from baseline cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks.)
  • Waist circumference(Change from baseline waist circumference at 12 weeks)
  • Flexibility testing(Change from baseline Chair sit & reach and Back scratch at 12 weeks.)
  • Homeostasis Model Assessment of insulin resistance(Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.)
  • Balance testing(Change from baseline time up and go at 12 weeks.)
  • Muscle strength testing(Change from baseline arm-curl and chair stand at 12 weeks.)
  • Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde(Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks.)
  • Nitric oxide(Change from baseline Nitric oxide at 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr.Daroonwan Suksom

Principal Investigator

Chulalongkorn University

研究点 (2)

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