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临床试验/NCT06578325
NCT06578325已完成不适用

Effects of Thai Dance Meditation Exercise on Renal and Cerebrovascular Function in Elderly With Diabetic Kidney Disease

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Stroop test

研究概览

简要总结

Elderly with diabetic kidney disease who practiced Thai dance meditation training more favorable adaptations than normal daily life in improving glycemic control, kidney function, vascular function and cerebrovascular function.

详细描述

This cross-sectional study was to compare glycemic control, kidney function, vascular function, cerebrovascular function, physical fitness and quality of life between elderly with diabetic kidney disease who practiced Thai dance meditation training and normal daily life.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria included diabetic kidney disease (DKD) (as defined by the KDIGO (Kidney Disease Improving Global Outcomes 2012), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, albumin-to creatinine ratio (ACR): A3 [>300 mg/day; ACR, >300 mg/g (>30 mg/mmol)], GFR category 3 (moderately decreased) has now been divided into categories G3a [45-59 mL/ min1 /(1.73m2) and G3b [30 -44 mL/ min1/(1.73 m2) which represent mildly to moderately decreased function and moderately to severely decreased function and no previous exercise training in the past 6 months.
  • All participants were free from diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.
  • Participants had Montreal Cognitive Assessment - Thai (MoCa-T) scores between 18 24 points.
  • Not having uncontrolled high blood pressure (Systolic blood pressure; SBP) >159 mmHg and Diastolic blood pressure; DBP) > 99 mmHg

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

Stroop test

时间窗: Change from baseline Stroop test in second at 12 weeks.

Stroop test in second will be measured with EncephalApp - Stroop Test

Intrarenal artery

时间窗: Change from baseline renal arterial resistive index (RI) at 12 weeks.

Intrarenal artery will be measured by renal blood flow in renal arterial resistive index (RI) with ultrasonography equipment EPIQ 5G, Phillips.

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).

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).

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 in percent (Prodigy-Pro, GE healthcare).

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 in kilogram (Prodigy-Pro, GE healthcare).

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 measure 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.

estimate Glomerular filtration rate

时间窗: Change from baseline estimate Glomerular filtration rate at 12 weeks.]

estimate Glomerular filtration rate in ml/min/1.73 m2 will be calculated by CKD-EPI formular according to National kidney foundation recommendation.

Cystatin C

时间窗: Change from baseline blood urea nitrogen at 12 weeks

Cystatin C in mg/L will be measure with particle enhanced Immunoturbidimetric assay

Blood pressure

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

Blood pressure (systolic blood pressure, diastolic blood pressure, and mean arterial pressure) in mmHg will be measured with automated blood pressure in mmHg device (CARESCAPE V100, GE Dinamap).

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.

Pulsatility index

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

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

Fasting blood sugar

时间窗: Change from baseline fasting blood sugar at 12 weeks.]

Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction.

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 in beat per minute device (CARESCAPE V100, GE Dina map).

Renal function

时间窗: Change from baseline Blood urea nitrogen at 12 weeks.

Blood urea nitrogen (BUN) in milligram per deciliter will be measure by Kinetic test with urease and glutamate dehydrogenase with urease/glutamate dehydrogenase coupled enzymatic (Coupled enzymes)

Post Occlusive Reactive Hyperemia; PORH

时间窗: Change from baseline Post Occlusive Reactive Hyperemia; PORH at 12 weeks.

Evaluation of blood flow to the skin area in percent will be measured by Post Occlusive Reactive Hyperemia in percent; PORH with Laser Doppler flowmeter, Perimed AB, Sweden.

Trail Making Test-B

时间窗: Change from baseline Trail Making Test-B at 12 weeks

Trail Making Test-B in second cut off below 101 seconds that indicate dementia.

Urine albumin creatinine ratio

时间窗: Change from baseline urine albumin creatinine ratio at 12 weeks.

Urine albumin creatinine ratio will be measure with Immunoturbidimetric assay

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.

Glycosylated hemoglobin

时间窗: Change from baseline Glycosylated hemoglobin at 12 weeks.]

Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction.

Homeostasis Model Assessment of insulin resistance

时间窗: Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks.]

Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin.

Creatinine

时间窗: Change from baseline creatinine at 12 weeks.]

Creatinine in mg/dl will be measure with enzymatic assay

次要结局

  • Balance testing(Change from baseline time up and go at 12 weeks.])
  • Quality of life in patients with chronic kidney disease(Change from baseline at 12 weeks.)
  • .Flexibility testing(Change from baseline Chair sit & reach at 12 weeks.])
  • Flexibility testing(Change from baseline back scratch at 12 weeks.)
  • Waist circumference(Change from baseline waist circumference at 12 weeks])
  • Cardiopulmonary fitness(Change from baseline 6-minutes walk at 12 weeks.])
  • Interleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF- α), Brain derived neurotrophic factor, Malondialdehyde, Superoxide Dismutase.(Change from baselineInterleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF- α), Brain derived neurotrophic factor, Malondialdehyde, Superoxide Dismutase. at 12 weeks.])
  • Nitric oxide(Change from baseline Nitric oxide at 12 weeks.)
  • Body mass index (BMI)(Change from baseline BMI at 12 weeks.)
  • Muscle strength testing(Change from baseline chair stand at 12 weeks.])
  • Lipid profile(Change from baseline Nitric oxide at 12 weeks.] cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein 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

Faculty of Sports science

Chulalongkorn University

研究点 (2)

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