Clinical trial NCT04618120: Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery
Official title: Comparison of Exercise Practices With Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Exercise
Upper Extremity Dysfunction
Keywords: Virtual Reality Exercises
Breast cancer
Radiotherapy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 66
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare two different exercise approaches during the radiotherapy period in patients who have undergone breast cancer surgery.

Detailed description: Exercise therapies are effective methods in the treatment of complications after breast cancer surgery. The study aims to compare exercise practices with virtual reality-based exercise training during radiotherapy period after breast cancer surgery. Patients were randomly divided into 3 groups as virtual reality group, exercise group, and control group, considering the order of arrival at the clinic and the type of surgery (mastectomy and breast-conserving surgery). Patients in virtual reality group received virtual reality-based exercise training using Microsoft Xbox 360 Kinect (Redmond, WA). Patients in exercise group received an exercise program including range of motion, posture, stretching and breathing exercises. Both exercise groups participated in the exercise program for 30- 40 minutes, 3 days a week, as long as radiotherapy continued (5-6 weeks). Patients in the control group did not receive any exercise intervention as is done in the current practice. Assessment methods were applied at the beginning and at the end of the radiotherapy for all groups. Shoulder range of motion was measured using universal goniometer. Hand grip strength was measured using Jamar hand dynamometer. Shoulder proprioception was measured using Cybex (Lumex,NY,USA) isokinetic dynamometer. Upper extremity functional status, kinesiophobia, anxiety and depression level, fatigue and quality of life were evaluated with various questionnaires.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Being literate
* Having a diagnosis of unilateral breast cancer
* Having undergone surgery for breast cancer
* Radiotherapy will be applied for breast cancer treatment.

Exclusion Criteria:

* Metastasis
* Have an active infection
* Having a cardiac or neurological disease that would prevent participation in the study
* Having uncontrolled hypertension
* Having an orthopedic disorder that prevents exercise
* Having sensory or cognitive impairments that interfere with communication

Primary outcomes:
measure: Change in the shoulder range of motion
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in the grip strength assessed by hydraulic hand dynamometer
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in the shoulder proprioception assessed by isokinetic dynamometer
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in circumference of upper extremities
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in the functionality of upper extremities assessed by the Disability of Arm, Shoulder and Hand Questionnaire
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in kinesiophobia assessed by theTampa Kinesiophobia Scale
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in anxiety and depression level assessed by the Hospital Anxiety and Depression Scale
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in fatigue assessed by Piper Fatigue Scale
timeFrame: Baseline and after the exercise training (5-6 weeks)
measure: Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline and after the exercise training (5-6 weeks)
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Patient satisfaction was evaluated at the end of the 5-6 week exercise training.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences
state: Emek
Study officials:
affiliation: Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: İlknur Onurlu, PhD
role: PRINCIPAL_INVESTIGATOR
References: