Breast CancerNCT04618120
Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery
A study testing Virtual reality-based exercise and Exercise in people with Breast Cancer and Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Exercise, Upper Extremity Dysfunction
- What is being tested?
- Virtual reality-based exercise and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2017to 2 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences
Ankara, Emek, 06490
About this study
Official title: Comparison of Exercise Practices With 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.
Read the 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
- Being tested
- Virtual reality-based exercise, Exercise
- Keywords
- Virtual Reality Exercises, Breast cancer, Radiotherapy
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-based exerciseOther
Virtual reality-based exercises with "Microsoft Xbox 360 Kinect" and breathing exercises.
Patient education
ExerciseOther
Shoulder range of motion, stretching, posture and breathing exercises. Patient education
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-based Exercise Group | Experimental | 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. Receives: Other: Virtual reality-based exercise |
| Exercise Group | Experimental | 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. Receives: Other: Exercise |
| Control Group | No intervention | Only patient education on general considerations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the shoulder range of motion
Universal Goniometer
Measured: Baseline and after the exercise training (5-6 weeks)
Change in the grip strength assessed by hydraulic hand dynamometer
Jamar Hydraulic Hand Dynamometer
Measured: Baseline and after the exercise training (5-6 weeks)
Change in the shoulder proprioception assessed by isokinetic dynamometer
Cybex 770 Norm isokinetic dynamometer (Lumex Inc. NY,USA)
Measured: Baseline and after the exercise training (5-6 weeks)
Change in circumference of upper extremities
Lymphedema circumference measurement
Measured: Baseline and after the exercise training (5-6 weeks)
Change in the functionality of upper extremities assessed by the Disability of Arm, Shoulder and Hand Questionnaire
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".
Measured: Baseline and after the exercise training (5-6 weeks)
Change in kinesiophobia assessed by theTampa Kinesiophobia Scale
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.
Measured: Baseline and after the exercise training (5-6 weeks)
Change in anxiety and depression level assessed by the Hospital Anxiety and Depression Scale
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.
Measured: Baseline and after the exercise training (5-6 weeks)
Change in fatigue assessed by Piper Fatigue Scale
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.
Measured: Baseline and after the exercise training (5-6 weeks)
Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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.
Measured: Baseline and after the exercise training (5-6 weeks)
Secondary outcomes (1)
Patient Satisfaction
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.
Measured: Patient satisfaction was evaluated at the end of the 5-6 week exercise training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start22 May 2017
- Primary completion2 Jan 2019
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Onurlu, Gazi University
- Investigators
- İlknur Onurlu, PhD, Principal investigator, Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618120
- Sponsor's protocol ID
- 2407471012
- Status last verified
- Nov 2020
- First submitted
- 21 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exercise Practices With Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04618120
- Acronym / sponsor ID
- 2407471012
- Conditions
- Breast Cancer, Exercise, Upper Extremity Dysfunction
- Keywords
- Virtual Reality Exercises, Breast cancer, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-based Exercise Group | Experimental | Other: Virtual reality-based exerciseVirtual 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. |
| Exercise Group | Experimental | Other: ExerciseStretching 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. |
| Control Group | No intervention | –Only patient education on general considerations. |
Who may qualify
- Ages
- 28 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality-based exerciseVirtual reality-based exercises with "Microsoft Xbox 360 Kinect" and breathing exercises. Patient education | Other | Virtual Reality-based Exercise Group |
| ExerciseShoulder range of motion, stretching, posture and breathing exercises. Patient education | Other | Exercise Group |
Primary outcome
Change in the shoulder range of motion
Time frame: Baseline and after the exercise training (5-6 weeks)
Universal Goniometer
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
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)
Change in circumference of upper extremities
Time frame: Baseline and after the exercise training (5-6 weeks)
Lymphedema circumference measurement
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".
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.
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.
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.
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.
1 secondary outcome
Patient Satisfaction
Time frame: Patient satisfaction was evaluated at the end of the 5-6 week exercise training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlknur Onurlu, PhD principal investigator
Gazi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality-based exercise and Exercise in people with Breast Cancer and Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the shoulder range of motion (time frame: Baseline and after the exercise training (5-6 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.