Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer

Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer: A Randomized, Single-blind, Controlled Trial

In this study,we aimed to examine the effects of Hatha yoga on PA and QoL in patients with breast cancer.

Patients will be randomized to receive the yoga group and the control group.Hatha yoga will be practiced twice a week for 10 weeks for intervention group.The PA of the patients will be assessed using a body analysis instrument and QoL was evaluated with an EORTC-Q questionnaire both before treatment and at week 10.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Yoga

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients between the ages of 18 and 70, witha diagnosis of breast cancer

Exclusion Criteria:

• Patients with recurrent or progressive disease, or with serious heart or pulmonary disease, with uncontrolled hypertension, infection, cognitive function disorder, psychiatric disease or musculoskeletal system conditions that would prevent exercise, and those who had taken part in a regular exercise program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Group; Hatha yoga will be practiced twice a week for 10 weeks	Other: Yoga; Each class started with a check-in period during which any questions or concerns could be raised, after which the patients were given 5 minutes for seated meditation and 10 minutes for Shavasana (lying down in a restorative position). The following poses were instructed during the course: standing poses with mountain pose (tadasana), chair pose (utkatasana), extended triangle pose (utthita trikonasana), extended side angle pose (utthita parshvakonasana), warrior 1 (virabhadrasana 1), warrior 2 (virabhadrasana 2) and tree pose (vrikshasana). The intervention was applied twice a week for 10 weeks.
No Intervention: Control group; This group will not have any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase Angle	Phase angle was evaluated with a Tanita body composition monitor (Tanita Corp., Tokyo, Japan). Electrodes are placed on both feet and both hands that send electrical signals from the body to a single independent unit. Voltages are measured at the top of the thumbs on both hands and both heels. A high-frequency electric current (90μA at 50 kHz) is applied, and the Resistance (R) and Reactance (xc) values are measured between the hands and feet. Internal software calculates the phase angle based on the following formula: Phase angle (PhA) = Reactance (xc) / Resistance (R) * (180 / π)	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The European Organization for Research and Treatment of Cancer Quality of life (EORTC QLQ-C30) questionnaire	The European Organization for Research and Treatment of Cancer Quality of life (EORTC QLQ-C30) questionnaire; This 30-question survey is conducted to evaluate QoL in patients with breast cancer and assesses any symptoms that occurred in the previous two weeks. The questionnaires are divided into three scales: global health scale (GHS), functional scale (FS), and symptom scale (SS). High scores in the functional and global health scales indicate a good QoL, while high scores on the symptom scale point to a high level of problems	10 weeks
Arm Volume	Patients were also evaluated for the lymphedema of the limbs is assessed through circumferential and volumetric methods. Circumferential upper limb measurements were carried out with the arm abducted to 30°, starting at the level of the carpometacarpal joint, and at every 5 cm proximal to this point along with both limbs	10 weeks
Body-Mass Index	Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.	10 weeks

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2015
• Primary Completion (Actual): November 5, 2015
• Study Completion (Actual): November 5, 2015

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; Quality of Life; Phase Angle; Hatha Yoga
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Yoga-PA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No