Walking Meditation Exercise in Breast Cancer Patients

Study Overview
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Brief Summary
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This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy

Detailed Description
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Walking Meditation program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking while listening to the sound Budd and Dha and squeeze rubber balls according to the sound in order to practice mindfulness while walking. In phase 1 (week 1-6), Walking Meditation will be conducted at initial moderate intensity (41-50% heart rate reserve) 3 sets, 10 minutes per set and rest 3 minutes between set In phase 2 (week 7-12), the training intensity will be increased to ultimate moderate intensity (51-60% heart rate reserve) 3 sets, 15 minutes per set and rest 3 minutes between set. In both phases of the training, the frequency of Walking Meditation training is three times a week.

Official Title
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Effects of Walking Meditation on Vascular Function in Breast Cancer Patients Receiving Anthracyclines Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria included stage 1-2 of Breast cancer patients after an operation with or without Hormone Receptor Positive and HER2 Positive. All participants will be planned to use Anthracyclines chemotherapy in next 1 month by oncologist. All participants did not participate in any exercise training in the past 6 months All participants are free from acute or chronic renal failure, Heart Failure, Myasthenia gravis, pregnancy and history of smoke. Exclusion Criteria: 1. Participants will be excluded if they dropped out or completed less than 80% of the training schedule.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Meditation<br>Walking Meditation program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking while listening to the sound Budd and Dha and squeeze rubber balls according to the sound in order to practice mindfulness while walking. In phase 1 (week 1-6), Walking Meditation will be conducted at initial moderate intensity (41-50% heart rate reserve) 3 sets, 10 minutes per set and rest 3 minutes between set In phase 2 (week 7-12), the training intensity will be increased to ultimate moderate intensity (51-60% heart rate reserve) 3 sets, 15 minutes per set and rest 3 minutes between set. In both phases of the training, the frequency of Walking Meditation training is three times a week. | Other: Exercise<br>* Walking meditation exercise program<br>|
| No Intervention: No Walking meditation<br>keep regular activities, sedentary life style. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 forearm. The brachial artery will be illustrated above the antecubital fossa in the longitudinal plane. Brachial FMD will be measured at resting and the cuff placed around the 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, up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Intima-Media Thickness: IMT | Intima-Media Thickness will be assessed with the ultrasound equipment (CX50, Philips, USA). | baseline, up to 12 weeks | 
| Change from baseline in Peripheral arterial stiffness | Pulse wave velocity (brachial-ankle PWV) measurement will be assessed by using Omron Colin VP1000. | baseline, up to 12 weeks | 
| Change from baseline in venous blood flow | Venous blood flow will be assessed with the ultrasound equipment (CX50, Philips, USA). The Basilic vain will be illustrated in the longitudinal plane. Venous blood flow will be measured at resting and squeezing hand for 3 minutes and 5 minutes of recovery. Venous blood flow will be calculated from the formula CSA x V when CSA is the cross sectional area of Basilic vain, V is the velocity in vessel. | baseline, up to 12 weeks | 
| Change from baseline in blood chemistry | Nitric oxide (NO) will be measured in serum samples with the commercial assay kit. Malondialdehyde (MDA) will be determined in plasma samples using the High Performance Liquid Chromatography (HPLC). Interleukin-6 (IL-6) will be measured in serum samples with the ELISA kit. hs-CRP will be measured in serum samples with the ELISA kit. | baseline, up to 12 weeks | 
| Change from baseline in Maximal oxygen consumption | Maximal oxygen consumption (VO2max) will be assessed by Bruce Ramp Protocol for treadmill test with Stationary Gas Analyzer (Vmax™ Encore 29 system, Yorba Linda, CA). | baseline, up to 12 weeks | 
| Change from baseline in Cardiac output and stroke volume | Cardiac output and stroke volume will be measured by using Physioflow (PF07 enduro). | baseline, up to 12 weeks | 
| Change from baseline in Body Mass Index (BMI) | Body Mass Index (BMI) will be measured using Body Composition Analyzer (Model ioi 353, Jawon Medical Co. Ltd., Korea). BMI will be calculated by dividing weight in kilograms by height in metres squared. Unit of BMI is kg/m2. | baseline, up to 12 weeks | 
| Change from baseline in stress indicators | Serum cortisol will be measured with cortisol kit. | baseline, up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking Meditation, Vascular Function, Flow-mediated dilatation, Breast Cancer Patients, Anthracyclines Chemotherapy