Walking Meditation Exercise in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676531
• Other study ID #: SPSC-5
• Status: Completed
• Phase: N/A
• First received: January 17, 2016
• Last updated: April 9, 2018
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Exercise
Walking meditation exercise program

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in stress indicators	Serum cortisol will be measured with cortisol kit.	baseline, up to 12 weeks