Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery

NCT ID: NCT04618120

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2019-03-02

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.

Conditions

Breast Cancer; Exercise; Upper Extremity Dysfunction

Keywords

Virtual Reality Exercises; Breast cancer; Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality-based Exercise Group

Virtual reality-based exercises, breathing exercises and patient education on general considerations.

Virtual reality-based exercises were done using the "Microsoft Xbox 360 Kinect" system. Among the 'Kinect Sports' games, especially tennis, table tennis, boxing and bowling games including upper extremity movements were selected. These games require all-directional and repetitive motion of the shoulder and elbow joint. Patients played the games using the operated / affected side arms. Between games, the patient was rested in a chair. In the meantime, deep breathing exercises were done.

The patients participated in virtual reality-based exercises 3 days a week (15-18 sessions in total) during the radiotherapy treatment continued (5-6 weeks). Each exercise session was set to last 30-40 minutes in total.

Group Type: EXPERIMENTAL

Virtual reality-based exercise

Intervention Type: OTHER

Virtual reality-based exercises with "Microsoft Xbox 360 Kinect" and breathing exercises.

Patient education

Exercise Group

Stretching exercises, range of motion exercises, posture exercises, breathing exercises and patient education on general considerations.

11 different exercises consisting of shoulder range of motion in all directions, stretching exercises, posture exercises and breathing exercises were performed in the presence of a physiotherapist.The patients participated in this exercise program 3 days a week (15-18 sessions in total) during the radiotherapy treatment continued (5-6 weeks). One session of the exercises was completed in an average of 30-40 minutes. The same exercises were repeated in each session.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Shoulder range of motion, stretching, posture and breathing exercises. Patient education

Control Group

Only patient education on general considerations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality-based exercise

Virtual reality-based exercises with "Microsoft Xbox 360 Kinect" and breathing exercises.

Patient education

Intervention Type: OTHER

Exercise

Shoulder range of motion, stretching, posture and breathing exercises. Patient education

Intervention Type: OTHER

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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

İlknur Onurlu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlknur Onurlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Locations

Gazi University Faculty of Health Sciences

Ankara, Emek, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2407471012

Identifier Type: -

Identifier Source: org_study_id