NCT02123901

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 16, 2015

Status Verified

August 1, 2013

Enrollment Period

10 months

First QC Date

April 18, 2014

Last Update Submit

September 15, 2015

Conditions

Keywords

Mind and body ExerciseFlow mediated dilationDiabetes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Change from baseline in stress indicators

    Baseline, Week 12

  • Change from baseline in physical fitness

    Baseline, Week 12

  • Change from baseline in Peripheral arterial stiffness

    Baseline, Week 12

  • Change from baseline in ankle-brachial index.

    Baseline, Week 12

  • Change from baseline in blood chemistry

    Baseline, Week 12

Study Arms (2)

Walking meditation & Walking

EXPERIMENTAL
Other: Walking MeditationOther: Walking

Walking meditation & No exercise

ACTIVE COMPARATOR
Other: Walking MeditationOther: No exercise

Interventions

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.

Also known as: Buddhist Walking Meditation
Walking meditation & No exerciseWalking meditation & Walking
WalkingOTHER

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.

Walking meditation & Walking

Sedentary life style.

Walking meditation & No exercise

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Participants were excluded if they dropped out or completed less than 80% of the training schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Primary Health Promoting Hospital

Prapadang, Changwat Samut Prakan, 10130, Thailand

Location

Related 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.

    PMID: 24102912BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Walking

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Daroonwan Suksom, Ph.D.

    Faculty of Sports Science, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Sports Science

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 28, 2014

Study Start

December 1, 2013

Primary Completion

October 1, 2014

Study Completion

February 1, 2015

Last Updated

September 16, 2015

Record last verified: 2013-08

Locations