- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123901
The Effect of Walking Meditation Training on Glycemic Control and Vascular Function in Patients With Type 2 Diabetes
September 15, 2015 updated by: Assoc. Prof. Dr.Daroonwan Suksom, Chulalongkorn University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Samut Prakan
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Prapadang, Samut Prakan, Thailand, 10130
- The Primary Health Promoting Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Walking meditation & Walking
|
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:
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.
|
Active Comparator: Walking meditation & No exercise
|
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:
Sedentary life style.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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].
|
Baseline, Week 12
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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
|
baseline, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in stress indicators
Time Frame: Baseline, Week 12
|
|
Baseline, Week 12
|
Change from baseline in physical fitness
Time Frame: Baseline, Week 12
|
|
Baseline, Week 12
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Change from baseline in Peripheral arterial stiffness
Time Frame: Baseline, Week 12
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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
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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.
|
Baseline, Week 12
|
Change from baseline in blood chemistry
Time Frame: Baseline, Week 12
|
|
Baseline, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daroonwan Suksom, Ph.D., Faculty of Sports Science, Chulalongkorn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
April 18, 2014
First Submitted That Met QC Criteria
April 25, 2014
First Posted (Estimate)
April 28, 2014
Study Record Updates
Last Update Posted (Estimate)
September 16, 2015
Last Update Submitted That Met QC Criteria
September 15, 2015
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPSC-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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