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Standart exercise protocol and KİNECT® video based physiotherapy

The treatment protocol of the study group will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises.In total, a 25-minute Kincet® video game program will be applied in addition to the 15-minute basic and standart exercise program.

Standart exercise protocol and Upper extremity rehabilitation

The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol

The treatment protocol will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises. and shoulder proprioception .In addition to the standart exercise therapy, Kincet® video game program will be applied .

study group

The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol

Control group

The main objective of the study is to investigate the effects of Kinect® video based technology on pain, functionality, muscle strength, fatigue and quality of life in patients with breast cancer surgery and axillary node dissection.

Introduction: Breast cancer is the most common cancer seen in women. 1.7 million new cases have been reported in the world and have been shown as the fifth cause of death among women.There are many risk factors in etiogenesis, including gender, family history, age, obesity, malnutrition in postmenopausal period, hormone therapy, after 30 years of first birth, alcohol consumption and physical activity inadequacy. Pain and functional disorders are common complications after post-mastectomy in upper extremity. After mastectomy surgery ,pain in the shoulder, fatigue, decrease in range of motion, restriction of daily living activities, decrease of muscle strength, postural inbalance,, neuropathy and lymphedema may occur in the acute and chronic period.

Patients with breast cancer need a multidisciplinary and ongoing physiotherapy program.New technologies provide more motivational involvement for patients according to regular care and standard programs. Microsoft Kinect® is a virtual exercise program that is an application. It has been in use for rehabilitation among physical therapists for different deseas.The Kinect® application is a special technological approach that allows to follow the movements of the body. Microsoft Kinect® virtuel reality video games are promissing rehabilitation options because they involve upper extremity practise.

Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to two groups:

Experimental group- where the participants will be treated with standart exercise therapy and Kinect® video-game-based technology

Control Group - Standart exercise therapy and upper extremity rehabilitation-oriented physiotherapy program will be applied.

The evaluations will be repeated at the beginning of the study and at the end of the sixth week. Data obtained from the study will be analyzed using appropriate statistical methods. Patients will be received to therapy which upper extremity rehabilitation or Kinect based video game play under physiotherapist supervision for two days a week for six weeks. Patients will be supported by the home exercise program, except during sessions. Participants' joint range of motion in the initial assessments will be measured by electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate evaluation positions and grip force asssessment by Saehan Hydraulic Hand Dynamometer . In assessing pain, pain levels at rest and during activity will be questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via Disabilities of the Arm Shoulder and Hand Anketi (DASH). Environmental measurement differences between upper extremities with and without operation will be assessed with made in the arm, forearm and the wrist. In assessing Quality of life will be assessed European Organization for Research and Treatment of Cancer EORTC QLQ-C30 - EORTC- BR23 and finally fatique of individuals will be assessed via Cancer Fatigue Scale -CFS.

Sample size: 17 women for each group. Data Analysis:Data obtained from the study will be analyzed using appropriate statistical methods.

KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery

Disabilities of the Arm Shoulder and Hand ( DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.The DASH questionnaire consists of three parts.The first part consists of 30 questions. 21 questions assess the difficulty of the patient in daily life activities, 5 question symptoms, and the remaining 4 questions assess social function, work, sleep, and self-confidence of the patient.In the DASH questionnaire, questions are answered in 5-point likert system. 1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all. The total score varies between 0 and 100 points and the low score indicates good health.

Tampa Kinesiophobia Scale will be used to assess the fear of movement. It is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury. 1 = Absolutely not, 4 = Completely agree.When the total score is between 17 and 68, a higher score means that there is more fear of movement.

The European Organization for Research and Treatment of Cancer EORTC QLQ-C30 (version 3.0) is a cancer-specific measure of life quality. It consists of 30 items to assess physical, role, emotional, cognitive and social functioning, global health status or qualitiy of life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.

Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.

Visual Analogue Scale is one of the simple and common methods used in pain assessment. Self reported pain intensity during the rest and the activity measured by 0-10 centimeter chart. Visual Analogue Scale (VAS), where 0 indicates no pain or best and 10 indicates the most intense pain imaginable or worst. The patient will mark the severity of the pain on a 10 cm long chart.

Hand-held dynamometer will be used to evaluate shoulder muscles' strength

Upper arm circumference (millimeters) was measured to the nearest millimeter with a steel tape. Measurement will be made wrist, with 10 cm proximal of the wrist, at the lateral epicondyle, and 10 cm proximal of the elbow while arm hanging relaxed.

Grip strength was evaluated by hand grip dynamometry (Saehan Hydraulic Hand Dynamometer ) Measurements were performed in affected side according to positions defined by American Society of Hand Therapists (sitting with the shoulder adducted to the side and the elbow flexed 90° with the forearm and wrist in the neutral mid-position)

The Cancer Fatique scale (CFS) will be used to evaluate fatique. The cancer fatigue scale (CFS) was developed for the purpose of identifying and measuring fatigue in cancer patients, and its validity was evaluated in cancer patients and also in a scale determined specifically in breast cancer cases.The scale consists of 15 items and three subscales; physical, affective, and cognitive. Each item is scored between 1 and 5. 1 is never asked, 5 is too much.The high score indicates the excess of fatigue severity.The maximum total score is 60.

Acibadem University

Breast cancer patients with or without breast cancer surgery, with or without mastectomy, with or without lymphedema

inci ayas

ilke keser

elif sakizli erdal

Breast cancer is the most common type of cancer among women and covers 25% of all cancers. After mastectomy and reconstruction, many patients develop various upper extremity complications such as joint movement limitation, pain, lymphedema, and axillary cord. Because of such upper extremity problems, evaluation and treatment of upper extremity functions are important. Upper extremity functions are generally evaluated with questionnaires filled out by the patients themselves and which reflect their own perspectives subjectively. However, these questionnaires cannot reflect the observations and evaluations of the clinicians. Performance tests are important for clinicians to make decisions.

With this study, we want to examine the usability of the FIT-HaNSA test in the evaluation of upper extremity functions in patients with breast cancer. Our hypothesis; The FıtHaNSA test is successful in evaluating the upper extremity function in patients with breast cancer.

The Validity and Reliability of FIT-HaNSA in Breast Cancer Patients

The Validity and Reliability of FIT-HaNSA (Functional Impairment Test-Hand and Neck/Shoulder/Arm) in Breast Cancer Patients

Only study officials will be able to view patient data The statistical analysis will also be done by the study officials.

FIT-HaNSA protocol includes 3 steps.In the first step of the test 3 weights of 1kg are placed on the shelf at the waist level of the individual at 10 cm intervals.The person moves these weights in rows to the 25 cm upper rack and then place them back on the lower rack.The person is asked to continue this process for 5 minutes.In the second step of the test, the first shelf is placed at eye level, the second shelf is placed 25 cm below it and the procedures in the first step are repeated.In the 3rd step, a wooden plate with 3 holes is placed perpendicular to the shelf at eye level of the individual.The hole in the middle is left empty by placing nuts and bolts in the first and third holes before. The individual must return to the starting point in order by attaching the bolt in the first hole to the second hole, the bolt in the third hole to the first hole and finally the bolt in the second hole to the third hole and this process is 5 minutes.

Upper extremity disability will be evaluated with DASH questionnaire (Disabilities of the Arm, Shoulder and Hand). It is a questionnaire consisting of 30 questions that evaluates the dysfunctions of the entire upper extremity. It consists of questions evaluating the degree of difficulty in performing different activities using the upper extremity in daily life (21 questions), pain, numbness, joint stiffness and weakness symptoms (5 questions), social life, sleep, work and psychological status (4 questions) in the last week.

Upper extremity functionality will be evaluated with Upper Extremity Functional Index (UEFI). It is a questionnaire consisting of 20 questions that questions the functional difficulty of the upper extremity in daily life activities. Each question is scored between 0 and 4 (0: extremely difficult, 4: no difficulty).

Shoulder disability will be evaluated with Shoulder Pain and Disabilty Index (SPADI). The scale, which consists of 13 questions in total, has two subsections as pain and disability. The pain section consists of 5 questions describing the pain of the patient, and the disability section consists of 8 questions that indicate the degree of difficulty experienced when using the upper extremity. Each question is scored from 0 to 10 (0 is no difficulty, 10 is very difficult).

Gazi University

Principal Investigator

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.

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.

Only patient education on general considerations.

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

Patient education

Virtual reality-based exercise

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

Exercise

İlknur Onurlu, PhD

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.

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.

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

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

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

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".

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.

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.

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.

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.

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.

Participants in this group will take part the general exercise program delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application.

Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules.

A 10-week integrated physiotherapy and general exercise intervention compared to a general exercise intervention alone.

general exercise

Margaret L McNeely

Margaret McNeely, PhD

Margaret L. McNeely, PhD

Margaret McNeely

The primary purpose of this study is to determine the feasibility of our proposed intervention approach involving (1) an integrated physiotherapy and exercise intervention for individuals with breast cancer who are undergoing chemotherapy and (2) delivery of programming via an electronic health (eHealth) application. The secondary objective is to determine the efficacy of the program on upper extremity outcomes, general physical fitness, cancer treatment-related symptoms and quality of life.

EMPOWER is a multi-methods feasibility randomized controlled trial. The study will recruit a minimum of 30 individuals with breast cancer who are undergoing adjuvant chemotherapy following surgery for breast cancer. The study will be conducted in two phases:

Phase I: Randomized Controlled Feasibility Trial The aim of this phase is to determine the feasibility and preliminary efficacy of a 10-week integrated physiotherapy and exercise intervention compared to an exercise intervention alone.

Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating, Active Living and Mindful Energy (HEAL-ME) Research App design, program delivery, program components and perceived effectiveness of the intervention at the level of the participant.

PHASE I: Randomized Controlled Feasibility Trial A randomized controlled trial design will be used to randomize individuals with breast cancer to one of two groups: 1) Comparison group: general exercise intervention + education; and 2) Experimental group: integrated physiotherapy and general exercise intervention + education. The study will be carried out over a 10-week period. The outcome measures will be assessed at baseline and at 10 weeks.

Randomization: An independent researcher will generate the randomization sequence using a computer-generated randomization module within the Trial's REDCap database. Randomization will occur following baseline testing.

Interventions:

Group 1 (Comparator): Hybrid In-Persona and HEAL-ME delivered General Exercise:

Participants in this group will take part the general exercise program delivered in-person and through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions in-person or virtually (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application. Exercise regimen: The exercise regimen follows the general principles of overload, progression, and specificity. The exercise program consists of full body exercise (e.g., comprising aerobic, resistance training, core stability, balance and flexibility training) a minimum of 2 times per week (one group virtual session and one independent self-directed session). Education: educational materials in written (PDF format) will be included in the Education module: resources section of the HEAL-ME application. Topics include the exercise expectations, behavior change strategies, home exercise equipment and how to exercise safely.

Group 2 (Experimental): Hybrid in-person and HEAL-ME Integrated Physiotherapy and exercise:

Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered in-person and through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions in-person or virtually, (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules. Integrated physiotherapy and exercise regimen: The integrated physiotherapy and exercise regimen will follow the exercise regimen as described in Group 1. For this group, breast cancer specific shoulder range of motion and stretching exercises will be incorporated into the warm-up and cool-down components of both group and individual exercise sessions. Education: educational videos will be available on the application and include topics such as cancer-related fatigue, risk reduction for lymphedema and pelvic health after breast cancer.

Educational materials in written (PDF format) will be included in the Education module: resources section of the HEAL-ME application. Topics include the benefits of exercise during chemotherapy for breast cancer, exercise behavior change strategies, and how to exercise safely.

Blinding An independent assessor, who is blinded to the group assignment will carry out all the measurements. Training of the assessor will be conducted on the measurement procedures related to the upper body and fitness outcome measurement protocols prior to study initiation.

PHASE II: Assessment of HEAL-ME App Design, Acceptability, and Program Components The app design, acceptability, and program components will be assessed following completion of the study through focus groups and semi-structured interviews to explore the experiences of individuals randomized to the HEAL-ME experimental group. The purpose of this phase is to assess different aspects of HEAL-ME related to the program delivery, different components contents, and time commitment. The results of this phase will inform further development of the HEAL- ME breast cancer module.

Phase II Data Collection Focus Groups: E-intervention group participants will be invited to participate in a focus group or semi-structured interview session that aim to capture participant perspectives and experiences, as well as any facilitators or barriers to use of the HEAL-ME application.

Qualitative Data Analysis The focus groups discussions will be audio recorded and transcribed. Two researchers will read and then reread the transcripts for accuracy against the audio recordings. The investigators will conduct an inductive content analysis to capture the participants' views about the program's acceptability and usability and ways to refine it. The inductive approach will enable a descriptive evaluation of the program from the participant's view. Two researchers will independently analyze the content of the focus group transcripts to identify evidence related to research objectives. Using the thematic analytic approach, the investigators will follow different processes described by Braun and Clarke. The data will be analyzed line by line by the researchers independently to identify patterns and key themes with example quotes from the data. Codes for similar meanings and highlighted terms will be developed, examined, and refined if necessary to identify the most expressive codes related to the research objectives. The process will be repeated a few times until concrete themes emerge and no further themes are identified. The generated themes will be reviewed and verified by a third researcher in order to increase the validity of the findings. Any coding discrepancies will be discussed and reconciled. Conceptual themes will be inductively originated from analysis through generating initial codes, followed by sub-themes, and finally, an overarching theme.

Independent assessors will be used for collection of objective outcomes. The independent assessors will be blinded to group allocation.

Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy

Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy (EMPOWER): A Randomized Controlled Feasibility Trial

On completion of the trial, data will be available through the University of Alberta's Dataserve

Defined as \>70% participants completing at least 70% of exercise sessions and the post-study assessment

Percentage of participants eligible who consent to participate in the study

Percentage of completed exercise and education modules

Functional Assessment of Cancer Therapy -breast (FACT-B+4)

Functional Assessment of Cancer Therapy - fatigue subscale (FACIT-F)

Godin Leisure Time Exercise Questionnaire

Active Shoulder Range of Motion: abduction

Active Shoulder Range of Motion: external rotation

Active Shoulder Range of Motion: internal rotation

Active Shoulder Range of Motion: horizontal abduction

Perometry for the measurement of lymphedema

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery	NCT03618433	Breast Cancer Upper Extremity... Mastectomy	study group Control group	18 Years - 55 Years	Acibadem University
The Validity and Reliability of FIT-HaNSA in Breast Cancer Patients	NCT04795778	Breast Cancer FIT-HaNSA Upper Extremity...		18 Years - 65 Years	Gazi University
Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery	NCT04618120	Breast Cancer Exercise Upper Extremity...	Virtual reality... Exercise	28 Years - 70 Years	Gazi University
Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy	NCT05254678	Breast Cancer Upper Extremity...	general exercis...	18 Years -	University of Alberta
KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery	NCT03618433	Breast Cancer Upper Extremity... Mastectomy	study group Control group	18 Years - 55 Years	Acibadem University

Spots Global Cancer Trial Database for upper extremity dysfunction