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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123901
• Other study ID #: SPSC-1
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: September 15, 2015
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: August 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Walking Meditation
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.
• Walking
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
Sedentary life style.

Locations

Country	Name	City	State
Thailand	The Primary Health Promoting Hospital	Prapadang	Samut Prakan

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Mitranun W, Deerochanawong C, Tanaka H, Suksom D. Continuous vs interval training on glycemic control and macro- and microvascular reactivity in type 2 diabetic patients. Scand J Med Sci Sports. 2014 Apr;24(2):e69-76. doi: 10.1111/sms.12112. Epub 2013 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

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