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

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

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

Conditions
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Elderly With Type 2 Diabetes

Intervention / Treatment
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* Other: Nordic walking in water
* Other: No exercise intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Participants were excluded if they dropped out or completed less than 80% of the training schedule

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nordic walking in water<br>The groups trained Nordic walking in water | Other: Nordic walking in water<br>* Nordic walking in water will be based on nordic walking in water at temperature 34◦C. Nordic walking in water will be conducted at moderate intensity (40-60% heart rate reserve). The program was exercised 60 minutes include warm-up and cool down. At first 6 weeks, The exercise intensity was 40-50% heart rate reserve and it will be increased 50-60% heart rate reserve. The training program will be performed 3 times per week for 12 weeks.<br>Other: No exercise intervention<br>* This group wasn't receive intervention program. The participants in this group will do following a physician who treat them. They can exercise according to the physician recommend.<br>|
| No Intervention: No exercise intervention<br>The groups did not receive exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General physiological data | 1.Blood pressure in mmHg will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap). | Change from baseline systolic blood pressure, diastolic blood pressure, and mean arterial pressure at 12 weeks. | 
| Heart rate | Heart rate in beats per minute will be measured with automated blood pressure device (CARESCAPE V100, GE Dinamap). | Change from baseline heart rate at 12 weeks. | 
| ฺBody fat | Body fat in percent will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare). | Change from baseline body fat at 12 weeks. | 
| Muscle mass and Weight | Muscle mass and weight in kilograms will be measured with dual energy x-ray absorptiometry (Prodigy-Pro, GE healthcare). | Change from baseline muscle mass and weight at 12 weeks. | 
| Arterial stiffness | Arterial stiffness will be measured with brachial-ankle pulse wave velocity in centimeter per second (VP-1000 plus, omrom Healthcare). | Change from baseline brachial-ankle pulse wave velocity at 12 weeks. | 
| Macro vascular function | Macro vascular function will be measured by brachial artery flow-mediated dilatation in percent with ultrasonography equipment (EPIQ 5G, Phillips). | Change from baseline brachial artery flow-mediated dilatation at 12 weeks. | 
| Cerebral blood flow | Cerebral blood flow in centimeter per second will be measured with ultrasonography equipment (EPIQ 5G, Phillips). | Change from baseline cerebral blood flow at 12 weeks. | 
| Cerebrovascular conductance index | Cerebrovascular conductance index in cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips). | Change from baseline cerebrovascular conductance index at 12 weeks. | 
| Cerebrovascular reactivity index | Cerebrovascular reactivity index in %cm/sec/mmHg will be measured with ultrasonography equipment (EPIQ 5G, Phillips). | Change from baseline cerebrovascular reactivity index at 12 weeks. | 
| Arterial compliance | 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). | Change from baseline Arterial compliance at 12 weeks. | 
| Pulsatility index | Pulsatility index in units will be measure with ultrasonography equipment (EPIQ 5G, Phillips). | Change from baseline Pulsatility index at 12 weeks. | 
| Montreal Cognitive Assessment | Montreal Cognitive Assessment in score (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function. | Change from baseline Montreal Cognitive Assessment at 12 weeks. | 
| Mini-Mental State Examination | Mini-Mental State Examination in scores (0 - 30 scores) cut off below 25 scores that indicate impairment cognitive function. | Change from baseline Mini-Mental State Examination at 12 weeks. | 
| Trail Making Test-B and Stroop test | 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. | Change from baseline Trail Making Test-B and Stroop test at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference in centimeters will be measure by waist tape | Change from baseline waist circumference at 12 weeks | 
| Flexibility testing | Flexibility testing will be measure by Chair sit & reach protocol and Back scratch in centimeters. | Change from baseline Chair sit & reach and Back scratch at 12 weeks. | 
| Muscle strength testing | Muscle strength testing will be measured by arm-curl test and chair stand test in repetitions in 30 seconds. | Change from baseline arm-curl and chair stand at 12 weeks. | 
| Balance testing | Balance testing will be measured by time up and go testing in seconds. | Change from baseline time up and go at 12 weeks. | 
| Cardiopulmonary fitness | Cardiopulmonary fitness will be measure by 2-minutes step test in repetitions. | Change from baseline 2-minutes step at 12 weeks. | 
| Cardiopulmonary fitness | Cardiopulmonary fitness will be measure by 6-minutes walk test in meters. | Change from baseline 6-minutes walk at 12 weeks. | 
| Fasting blood sugar | Fasting blood sugar in mg/dl will be measure with enzymatic assay using hexokinase reaction. | Change from baseline fasting blood sugar at 12 weeks. | 
| Glycosylated hemoglobin | Glycosylated hemoglobin in percent will be measure with enzymatic assay using hexokinase reaction. | Change from baseline Glycosylated hemoglobin at 12 weeks. | 
| Homeostasis Model Assessment of insulin resistance | Homeostasis Model Assessment of insulin resistance in units will be calculated with Fasting blood sugar and insulin. | Change from baseline Homeostasis Model Assessment of insulin resistance at 12 weeks. | 
| Lipid profile | Lipid profile will be measure by cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein in mg/dl. | Change from baseline cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein at 12 weeks. | 
| Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde | Tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde in pg/ml will be measure with ELISA assay kit. | Change from baseline tumor necrosis factor alpha, adiponectin, interleukin 1 beta, interleukin 6, brain derived neurotrophic factor, and malondialdehyde at 12 weeks. | 
| Nitric oxide | Nitric oxide in µM will measured with standard Griess reagents. | Change from baseline Nitric oxide at 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes mellitus, Cerebrovascular function, Cognitive impairment, Nordic walking in water, Physical fitness