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Completed

NCT Number: NCT02676531

Walking Meditation Exercise in Breast Cancer Patients

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Exercise

Other

Walking meditation exercise program

Primary outcomes

  1. Change from baseline in vascular reactivity

    Time frame: baseline, up to 12 weeks

    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.

Secondary outcomes

  1. Change from baseline in Intima-Media Thickness: IMT

    Time frame: baseline, up to 12 weeks

    Intima-Media Thickness will be assessed with the ultrasound equipment (CX50, Philips, USA).

  2. Change from baseline in Peripheral arterial stiffness

    Time frame: baseline, up to 12 weeks

    Pulse wave velocity (brachial-ankle PWV) measurement will be assessed by using Omron Colin VP1000.

  3. Change from baseline in venous blood flow

    Time frame: baseline, up to 12 weeks

    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.

  4. Change from baseline in blood chemistry

    Time frame: baseline, up to 12 weeks

    • 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.

  5. Change from baseline in Maximal oxygen consumption

    Time frame: baseline, up to 12 weeks

    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).

  6. Change from baseline in Cardiac output and stroke volume

    Time frame: baseline, up to 12 weeks

    Cardiac output and stroke volume will be measured by using Physioflow (PF07 enduro).

  7. Change from baseline in Body Mass Index (BMI)

    Time frame: baseline, up to 12 weeks

    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.

  8. Change from baseline in stress indicators

    Time frame: baseline, up to 12 weeks

    Serum cortisol will be measured with cortisol kit.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2016
Registry last updated
Apr 10, 2018

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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