The Effect of Walking Meditation Training on Glycemic Control and Vascular Function in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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Walking Meditation training would yield more favorable adaptations than walking alone in improving glycemic control and vascular function in patients with type 2 diabetes.

Official Title
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THE EFFECT OF WALKING MEDITATION TRAINING ON GLYCEMIC CONTROL AND VASCULAR FUNCTION IN PATIENTS WITH TYPE 2 DIABETES

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Walking Meditation
* Other: Walking
* Other: No exercise


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. 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: 40 Years
Maximum Age: 75 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: Walking meditation & Walking<br> | Other: Walking Meditation<br>* Walking Meditation training program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking on the treadmill while concentrated on foot stepping by voiced Budd and Dha with each foot step that contacted the floor to practice mindfulness while walking. Walking Meditation will be conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week.<br>* Other names: Buddhist Walking Meditation;Other: Walking<br>* Walking training program will be based on aerobic walking exercise. The subjects will perform walking on the treadmill and conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week.<br>|
| Active Comparator: Walking meditation & No exercise<br> | Other: Walking Meditation<br>* Walking Meditation training program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking on the treadmill while concentrated on foot stepping by voiced Budd and Dha with each foot step that contacted the floor to practice mindfulness while walking. Walking Meditation will be conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week.<br>* Other names: Buddhist Walking Meditation;Other: No exercise<br>* Sedentary life style.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glycemic control | The glycemic control will be quantified using blood samples. Fasting blood glucose, HbA1c, and insulin will be measured with standard procedures at the clinical laboratory (Bria Lab, Bangkok, Thailand).Homeostasis model assessment (HOMA), the parameter for insulin resistance, will be calculated by using equation of [Fasting glucose (mg/dL) × Insulin level (uU/mL) / 405]. | Baseline, Week 12 | 
| Change from baseline in vascular reactivity | Vascular reactivity or brachial artery flow-mediated dilatation (FMD) will be assessed with the ultrasound equipment (CX50, Philips, USA), using the blood occlusion technique on the right forearm. The brachial artery will be imaged above the antecubital fossa in the longitudinal plane. Baseline data will be monitored and the cuff placed around the right forearm will be inflated to 50 mmHg above systolic blood pressure for 5 minutes and then deflated for 5 minutes of recovery. FMD will be calculated from the formula FMD=(D2-D1)x100/D1 when D1 is the brachial artery diameter at baseline, D2 is the maximal post-occlusion brachial artery diameter | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in stress indicators | Plasma cortisol will be measured with standard procedures at the certified clinical laboratory (BRIA Lab, Bangkok, Thailand). Heart rate variability (HRV) will be measured using the Heart rate variability analyzer SA-3000P, Medicore Co.,Ltd, Korea | Baseline, Week 12 | 
| Change from baseline in physical fitness | Body composition will be measured using Body Composition Analyzer (Model ioi 353, Jawon Medical Co. Ltd., Korea). Maximal oxygen consumption (VO2max) will be assessed by Modified Bruce Protocol for treadmill test with Stationary Gas Analyzer (Vmax™ Encore 29 system, Yorba Linda, CA). Lower muscle strength will be measured with back and leg dynamometer. | Baseline, Week 12 | 
| Change from baseline in Peripheral arterial stiffness | Pulse wave velocity measurement will be assessed with MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA). All subjects were monitored with an EKG and PWV measurements in the computer and used as timing markers for PWV identification. | Baseline, Week 12 | 
| Change from baseline in ankle-brachial index. | Ankle-brachial index will be evaluated with a manual MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA) and will be calculated by dividing the highest ankle systolic blood pressure by the highest brachial systolic blood pressure. | Baseline, Week 12 | 
| Change from baseline in blood chemistry | Interleukin-6 (IL-6) will be measured in plasma samples with the ELISA kit (Human IL-6 high sensitivity ELISA, eBioscience, Austria). Nitric oxide (NO) will be measured in plasma samples with the commercial assay kit (Colorimetric nitric oxide assay kit, PromoKine, Germany). | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mind and body Exercise, Flow mediated dilation, Diabetes