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Walking Meditation Exercise in Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Exercise
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Walking Meditation, Vascular Function, Flow-mediated dilatation, Breast Cancer Patients, Anthracyclines Chemotherapy

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. The inclusion criteria included stage 1-2 of Breast cancer patients after an operation with or without Hormone Receptor Positive and HER2 Positive.
  2. All participants will be planned to use Anthracyclines chemotherapy in next 1 month by oncologist.
  3. All participants did not participate in any exercise training in the past 6 months
  4. 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.

Sites / Locations

  • Faculty of Sports Science, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Walking Meditation

No Walking meditation

Arm Description

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.

keep regular activities, sedentary life style.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in Intima-Media Thickness: IMT
Intima-Media Thickness will be assessed with the ultrasound equipment (CX50, Philips, USA).
Change from baseline in Peripheral arterial stiffness
Pulse wave velocity (brachial-ankle PWV) measurement will be assessed by using Omron Colin VP1000.
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.
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.
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).
Change from baseline in Cardiac output and stroke volume
Cardiac output and stroke volume will be measured by using Physioflow (PF07 enduro).
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.
Change from baseline in stress indicators
Serum cortisol will be measured with cortisol kit.

Full Information

First Posted
January 17, 2016
Last Updated
April 9, 2018
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT02676531
Brief Title
Walking Meditation Exercise in Breast Cancer Patients
Official Title
Effects of Walking Meditation on Vascular Function in Breast Cancer Patients Receiving Anthracyclines Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Walking Meditation, Vascular Function, Flow-mediated dilatation, Breast Cancer Patients, Anthracyclines Chemotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
No Walking meditation
Arm Type
No Intervention
Arm Description
keep regular activities, sedentary life style.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Walking meditation exercise program
Primary Outcome Measure Information:
Title
Change from baseline in vascular reactivity
Description
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.
Time Frame
baseline, up to 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Intima-Media Thickness: IMT
Description
Intima-Media Thickness will be assessed with the ultrasound equipment (CX50, Philips, USA).
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in Peripheral arterial stiffness
Description
Pulse wave velocity (brachial-ankle PWV) measurement will be assessed by using Omron Colin VP1000.
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in venous blood flow
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in blood chemistry
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in Maximal oxygen consumption
Description
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).
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in Cardiac output and stroke volume
Description
Cardiac output and stroke volume will be measured by using Physioflow (PF07 enduro).
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in Body Mass Index (BMI)
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Change from baseline in stress indicators
Description
Serum cortisol will be measured with cortisol kit.
Time Frame
baseline, up to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Sports Science, Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Walking Meditation Exercise in Breast Cancer Patients

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