None listed
Conditions
Brief summary
As a consequence of chemotherapy used in the treatment of breast cancer, prioprioception and postural control disorders often occur, which increases the risk of falls and reduces the quality of life of patients. According to researchers, physical training plays an important role in the treatment of breast cancer and its prevention. It is important to develop training programs that will be willingly undertaken by patients and will best eliminate functional disorders caused by chemotherapy. These trainings should also be tailored to various forms of treatment of patients, including hospital, outpatient and sanatorium treatment. In this study, physical trainings used in outpatient and sanatorium treatment will be assessed, which will be particularly focused on the treatment of postural control disorders. It is assumed that exercises conducted on an outpatient basis for 12 weeks (including mainly sensory motor exercises in the gym and in water) will contribute to the improvement of static and dynamic body balance. It is assumed that the improvement of static and dynamic body balance will also be obtained during a 3-week sanatorium treatment, during which physical training, including sensory-motor training in the gym and postural control exercises using virtual reality, will be carried out every day (except Sunday). . We also assume that both methods of therapy, i.e. therapy conducted in outpatient and sanatorium settings will improve the patients' quality of life.
Interventions
Two research groups will be created. One group will include patients treated for 12 weeks on an outpatient basis (Ambulatory Group). The second group will include patients treated for 3 weeks in a sanatorium (SPA Group). It will be a non-randomized clinical trial conducted in two independent therapeutic centers. An outpatient research group ("Ambulatory group") will be created in one center. It will include 15 women who come to the center for therapy and meet the inclusion criteria. In the second center (it is a spa treatment center) a second research group will be created ("SPA group"), which will include 45 women who come to the center for therapy and meet the criteria for inclusion in the study. The treatment results will be assessed separately in both groups and will not be compared with each other. In both therapeutic centers, patients will be examined by a doctor and a physiotherapist. They will be informed in writing about the purpose and course of the clinical trial and will eventually be included in the clinical trial after giving consent to participate in the trial. Both documents (information about the study and consent to participate in the study) are specially prepared for the needs of this study and have been approved by the bioethics committees (Consent of the Bioethics Committee for Scientific Research at the University of Physical Education in Katowice No. 3/2018 of November 15, 2018 and the Consent of the Bioethical Committee for Scientific Research at the University of Rzeszów in Rzeszów No. 2018/06/02 of June 15, 2018). Ambulatory Group. In the Ambulatory Group, therapy will last 12 weeks. During this period, physical exercises, education and psychotherapy will be conducted. Patients will participate in physical training 3 times a week. Twice a week, once a day, for 45 minutes exercises in the gym will be performed and once a week (once a day) for 60 minutes will be conducted aqua aerobics. All exercises will be programmed and supervised by a main physiotherapist specializing in oncological physiotherapy. Exercises in the gym will be conducted in groups of 5 by properly trained therapists. The presence of patients during exercises will be recorded each time. Any failure to complete the exercise program (e.g. absence of the patient from the exercise, or failure to complete the full exercise program) will also be noted. Exercises will be used to relax and stretch excessively tense and contracted torso muscles (mainly in the thoracic and cervical spine) and shoulder-scapular complex. Exercises will be conducted in sitting, lying and standing positions. Various types of gymnastic equipment will be used for the exercises, including gymnastic sticks, balls and gymnastic tapes. Sensory motor exercises for the trunk and lower limbs as well as body balance exercises will also be introduced. Sensory motor cushions and unstable platforms will be used in these exercises. Exercises will be conducted in sitting and standing positions. Exercises in water will be focused in particular on improving body balance and strengthening the muscles of the lower limbs, torso and upper limbs. The correctness of performing exercises (both in the gym and in the water will be supervised by the main therapist. SPA group In the SPA group, the therapy will last 3 weeks. During this time, patients will be given baleotherapy (2% saline baths), gym exercises (including exercises based on virtual reality feedback), education and psychotherapy. Exercises in the gym, including "traditional" exercises described below (45 minutes each) and exercises with virtual reality (45 minutes each) will be carried out 6 times a week (every day from Monday to Saturday). In total, during therapy, patients will participate in 18 physical trainings (18 times 45 minutes of "traditional" exercises and 18 times 45 minutes of exercises with virtual reality). Balneotherapy and physical exercises will be ordered by a medical doctor and will be carried out by physiotherapists. Exercises in the gym and exercises with virtual reality will be programmed and supervised by a main physiotherapist specializing in oncological physiotherapy. The presence of patients at balneotherapy and exercises will be recorded each time. Any withdrawal from the therapeutic program (absence from classes, failure to complete a full exercise program, etc.) will also be noted. Brine baths will be performed in the morning 3 times a week (Monday, Wednesday, Friday). During the first week, the duration of brine baths will be gradually extended - the first bath is 15 minutes, the second is 20 minutes and the third is 25 minutes. In the second and third week the baths will last 25 minutes. Exercises in the gym will be conducted in groups of 5 by properly trained therapists. Exercices will be conducted daily, six times a week (Monday to Saturday) for 45 minutes. Exercises will start at least 1 hour after the brine bath. Exercises will be used to relax and stretch excessively tense and contracted torso muscles (mainly in the thoracic and cervical spine) and shoulder-scapular complex. Exercises will be conducted in sitting, lying and standing positions. Various types of gymnastic equipment will be used for the exercises, including gymnastic sticks, balls and gymnastic tapes. Sensory motor exercises for the trunk and lower limbs as well as body balance exercises will also be introduced. Sensory motor cushions and unstable platforms will be used in these exercises. Exercises will be conducted in sitting and standing positions. Exercises using virtual reality will be conducted daily, 6 times a week (Monday to Saturday), for 45 minutes. They will start after the gym exercises, after a break of at least 30 minutes. These exercises will be focused in particular on improving static and dynamic postural control. Virtual reality (VR) is an image of artificial reality created with the help of computer technology, including characters, objects and events existing only in computer memory. This image is interactive in real time and during exercise the patient watches it on the monitor displaying the avatar. The avatar can be in the form of a human or other moving object (e.g. plane, cars etc.). The patient's task is to control the avatar's movements by making movements with the whole body or individual limbs. Observing the avatar's movements, the patient immediately obtains feedback on the accuracy of the exercise he performed. The accuracy of this exercise is also observed by a physiotherapist. After completing the exercise, the monitor displays a summary of the exercise accuracy as a percentage from 0 to 100%. This result is also saved in the computer's memory. The purpose of VR exercises is for patients to learn to perform specific motor functions in the virtual world in order to then use them in the real world. It is believed that VR can provide a high level of exercise repetition and allows the combination of motor and cognitive functions, requiring the patient to think abstractly, solve tasks and remember what researchers believe stimulates neurons and brain neuroplasticity. Education. In both groups all patients will receive the same written information on the basic principles of breast cancer prevention. The written information provided on the basic principles of breast cancer prevention will be designed specifically for this study. In both groups, patients will have the opportunity to take part in 12 educational meetings, lasting 45 minutes. In the Ambulatory Group, meetings will beperformed twice a week for the first 6 weeks of therapy. In the SPA Group, educational meetings will be conducted 4 times a week during the entire 3 week sanatorium treatment. In both groups, the presence of patients in meeting will be recorded. Educational meetings will be led by a main physiotherapist specializing in oncological therapy. At meetings, information on breast cancer prevention will be provided, including information on nutrition in oncological disease, lymphoedema and its prophylaxis, principles of oncological rehabilitation, risk factors of the disease, the importance of physical activity in the prevention and treatment of the disease, side effects from the oncological treatment. Psychotherapy. Eight psychotherapeutic meetings lasting 45 minutes will be organized in both groups. In the Ambulatory Group, meetings will be conducted once a week (on Monday), for the first 8 weeks of the therapy. In the SPA Group, during the three-week therapeutic program, three psychotherapeutic meetings (Monday, Wednesday and Friday) will be organized in the first and second week, and 2 meetings (Monday, Wednesday) will be held in the 3rd week. Meetengs will take place on the principle of mutual support group. In order to reduce the level of stress and anxiety of the patient, psychotherapy will take place in groups in which educational meetings and physical exercises will take place. The assumption of group educational meetings is to facilitate the patients mutual opening to problems related to the disease, exchange of knowledge and experiences, mutual support and reducing the fear of asking questions related to the disease. Psychoeducation will aim to raise the self-esteem of patients, make them aware of their own needs during illness, need to communicate their surroundings, eliminate feelings of guilt and social exclusion. Psychotherapy will be conducted by psychologists specializing in oncological therapy.
Sponsors
Study design
Eligibility
Inclusion criteria
Women between the ages of 30 and 65 who are willing to participate in the study, treated with chemotherapy for unresectable breast cancer, after surgical treatment of breast cancer (sparing or mastectomy). Completed chemotherapy and radiotherapy.
Exclusion criteria
Stage IV cancer disease according to TNM classification (ie very advanced cancer, with the presence of distant metastases); Medical contraindications to physical training used in research groups.