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Completed

NCT Number: NCT04692090

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

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.

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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

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

yoga

Other

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.

Primary outcomes

  1. Phase Angle

    Time frame: 10 weeks

    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)

Secondary outcomes

  1. The European Organization for Research and Treatment of Cancer Quality of life (EORTC QLQ-C30) questionnaire

    Time frame: 10 weeks

    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

  2. Arm Volume

    Time frame: 10 weeks

    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

  3. Body-Mass Index

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2020
Registry last updated
Dec 31, 2020

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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