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Completed

NCT Number: NCT04618120

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Exercise Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Upper Extremity Dysfunction

Age range

28 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Health Sciences

Ankara, Emek, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Virtual reality-based exercise

Other

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

Patient education

Exercise

Other

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

Primary outcomes

  1. Change in the shoulder range of motion

    Time frame: Baseline and after the exercise training (5-6 weeks)

    Universal Goniometer

  2. Change in the grip strength assessed by hydraulic hand dynamometer

    Time frame: Baseline and after the exercise training (5-6 weeks)

    Jamar Hydraulic Hand Dynamometer

  3. Change in the shoulder proprioception assessed by isokinetic dynamometer

    Time frame: Baseline and after the exercise training (5-6 weeks)

    Cybex 770 Norm isokinetic dynamometer (Lumex Inc. NY,USA)

  4. Change in circumference of upper extremities

    Time frame: Baseline and after the exercise training (5-6 weeks)

    Lymphedema circumference measurement

  5. Change in the functionality of upper extremities assessed by the Disability of Arm, Shoulder and Hand Questionnaire

    Time frame: Baseline and after the exercise training (5-6 weeks)

    The Turkish version of the Disability of Arm, Shoulder and Hand Questionnaire is used to evaluate functional status of upper extremities. The questionnaire consists of 30 questions. A score between 0-100 is obtained from the questionnaire. 0 point means "no disability", 100 point means "maximum level of disability".

  6. Change in kinesiophobia assessed by theTampa Kinesiophobia Scale

    Time frame: Baseline and after the exercise training (5-6 weeks)

    The Turkish version of theTampa Kinesiophobia Scale was used to determine the level of kinesiophobia. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. A score between 17-68 is obtained from the scale. The higher scores indicate higher kinesiophobia level.

  7. Change in anxiety and depression level assessed by the Hospital Anxiety and Depression Scale

    Time frame: Baseline and after the exercise training (5-6 weeks)

    The Turkish version of the Hospital Anxiety and Depression Scale was used to determine the anxiety and depression level. The scale consists of 14 questions in total. 7 of the questions measure depression, 7 measure anxiety. A total score between 0-42 is obtained from the sum of the anxiety and depression scores. The higher scores indivate higher depression and /or anxiety.

  8. Change in fatigue assessed by Piper Fatigue Scale

    Time frame: Baseline and after the exercise training (5-6 weeks)

    The Turkish version of Piper Fatigue Scale was used to determine the level of fatigue. The scale consists of 22 items (0-10 points) and 4 subscales: behavioral/severitiy (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Each subscale is scored individually and then aggregated together for an overall score. Higher scores indicate more fatigue.

    As a result of the average score; 0 points are interpreted as no fatigue, 1-3 points mild fatigue, 4-6 points moderate fatigue, 7-10 points severe fatigue.

    There are also 5 more questions in the scale that are not used in the subscale or total score calculation. These open-ended questions are about the duration of perceived fatigue, its causes, methods to alleviate fatigue and associated symptoms. They provide qualitative data.

  9. Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Time frame: Baseline and after the exercise training (5-6 weeks)

    The Turkish version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used to evaluate quality of life level. It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhea), financial impact, and overall quality of life. All scale scores are converted to range from 0 to 100. higher scores indicate better functioning for the functioning scales and overall quality of life; higher scores indicate higher symptom burden for the symptom scales.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: Patient satisfaction was evaluated at the end of the 5-6 week exercise training.

    The motivation of the exercises, the state of enjoying the exercise, believing that the exercise is beneficial, and the patient's willingness to continue the exercise were evaluated with 4 questions that they could answer with Likert-type answers.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Comparison of Exercise Practices With Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2020
Registry last updated
Nov 5, 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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