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Completed

NCT Number: NCT02123901

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Primary Health Promoting Hospital

Prapadang, Changwat Samut Prakan, 10130, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walking Meditation

Other

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.

Other names: Buddhist Walking Meditation

walking

Other

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.

No exercise

Other

Sedentary life style.

Primary outcomes

  1. Change from baseline in glycemic control

    Time frame: Baseline, Week 12

    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].

  2. Change from baseline in vascular reactivity

    Time frame: baseline, week 12

    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

Secondary outcomes

  1. Change from baseline in stress indicators

    Time frame: Baseline, Week 12

    • 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

  2. Change from baseline in physical fitness

    Time frame: Baseline, Week 12

    • 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.

  3. Change from baseline in Peripheral arterial stiffness

    Time frame: Baseline, Week 12

    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.

  4. Change from baseline in ankle-brachial index.

    Time frame: Baseline, Week 12

    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.

  5. Change from baseline in blood chemistry

    Time frame: Baseline, Week 12

    • 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).

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 28, 2014
Registry last updated
Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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