NCT04692090

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2015

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

December 30, 2020

Last Update Submit

December 30, 2020

Conditions

Keywords

Phase AngleHatha YogaBreast CancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    10 weeks

  • Arm Volume

    10 weeks

  • Body-Mass Index

    10 weeks

Study Arms (2)

Yoga Group

EXPERIMENTAL

Hatha yoga will be practiced twice a week for 10 weeks

Other: Yoga

Control group

NO INTERVENTION

This group will not have any intervention.

Interventions

YogaOTHER

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.

Yoga Group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ege University Faculty of Medicine, Physical Medicine and Rehabilitation Department

Study Record Dates

First Submitted

December 30, 2020

First Posted

December 31, 2020

Study Start

May 6, 2015

Primary Completion

November 5, 2015

Study Completion

November 5, 2015

Last Updated

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share