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Trial registered on ANZCTR


Registration number
ACTRN12619001599167
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
20/11/2019
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of physical exercises, including exercises conducted in the aquatic environment and exercises with feedback based on virtual reality, on the quality of life and postural control of women treated for breast cancer. Preliminary, clinical research.
Scientific title
The impact of physical exercises, including exercises conducted in the aquatic environment and exercises with feedback based on virtual reality, on the quality of life and postural control of women treated for breast cancer. Preliminary, clinical research.
Secondary ID [1] 298752 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 313685 0
Quality of live 313686 0
Postural control 313687 0
Condition category
Condition code
Cancer 312098 312098 0 0
Breast
Physical Medicine / Rehabilitation 312099 312099 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315018 0
Rehabilitation
Comparator / control treatment
A control group will be created. It will consist of patients referred to outpatient treatment, which within 6 weeks will not participate in the training programs provided for in the study, but after 6 weeks, for ethical reasons they will be able to participate in training programs. In the control group, the quality of life will be assessed at the beginning of the study and after the end of the 6-week period in the control group.

All the patients in the control group will be provided with educational activities in the form of lectures and individual consultations with a therapist, dietitian, etc. and psychologist's care (similar to research groups).
Control group
Active

Outcomes
Primary outcome [1] 320742 0
In the Outpatient group - the quality of life of patients assessed using the QLQ-C30 questionnaire.
Timepoint [1] 320742 0
At baseline, and week 6
Primary outcome [2] 320743 0
In SPA group - assessment of postural control carried out on the stabilometric platform.
Timepoint [2] 320743 0
At baseline, and week 3
Secondary outcome [1] 372709 0
In the Outpatient group - assessment of postural control carried out on the stabilometric platform.
Timepoint [1] 372709 0
At baseline, and week 6

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The physician will decide on the inclusion of the patient to the study. Patients will be referred to individual groups by the study manager.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In the out-patient treatment, the first 15 women who apply for a medical consultation will be be included in the experimental group ("Ambulatory Group")

In the spa treatment, 45 women will be enrolled in the study, who will come to the spa for the spa therapy, apply for a medical consultation at the spa and meet the inclusion criteria ("SPA Group").
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis of the test results will be carried out using appropriate statistical, parametric or non-parametric tests depending on the distribution of variables and other statistical measures (such as variations, skewness, kurtosis).

n both groups ("Ambulatory Group" and "SPA Group) the results after treatment will be compared to the results before treatment in order to obtain information whether the treatment used in both groups contributed to the health of patients (including improving their quality of life and postural control). Due to large differences in research methods (number of patients, therapeutic methods), treatment results will not be compared between groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2018
Date of last participant enrolment
Anticipated
2/12/2019
Actual
Date of last data collection
Anticipated
6/01/2020
Actual
Sample size
Target
60
Accrual to date
55
Final
Recruitment outside Australia
Country [1] 21689 0
Poland
State/province [1] 21689 0

Funding & Sponsors
Funding source category [1] 303308 0
University
Name [1] 303308 0
Academy of Physical Education in Katowice, Poland
Country [1] 303308 0
Poland
Funding source category [2] 303310 0
Government body
Name [2] 303310 0
European Regional Development Fund of the Kuyavian-Pomeranian Voivodeship, Poland
Country [2] 303310 0
Poland
Primary sponsor type
Hospital
Name
Rehabilitation Center "Technomex"
Address
Rehabilitation Center "Technomex", Szpragowa Str. 19, 44-141 Gliwice, Poland
Country
Poland
Secondary sponsor category [1] 303332 0
None
Name [1] 303332 0
Address [1] 303332 0
Country [1] 303332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303842 0
Bioethics Committee for human research at the Academy of Physical Education in Katowice
Ethics committee address [1] 303842 0
Ethics committee country [1] 303842 0
Poland
Date submitted for ethics approval [1] 303842 0
03/09/2018
Approval date [1] 303842 0
15/11/2018
Ethics approval number [1] 303842 0
3/2018
Ethics committee name [2] 303845 0
Bioethics Committee for scientific research at the University of Rzeszów
Ethics committee address [2] 303845 0
Ethics committee country [2] 303845 0
Poland
Date submitted for ethics approval [2] 303845 0
07/05/2018
Approval date [2] 303845 0
15/06/2018
Ethics approval number [2] 303845 0
2018/06/02).

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94994 0
Dr Anna Polak
Address 94994 0
Department of Physical Therapy, Academy of Physical Education, Mikolowska Str. 72A, 40-065 Katowice
Country 94994 0
Poland
Phone 94994 0
+48322075301
Fax 94994 0
+48322075301
Email 94994 0
[email protected]
Contact person for public queries
Name 94995 0
Anna Polak
Address 94995 0
Department of Physical Therapy, Academy of Physical Education, Mikolowska Str. 72A, 40-065 Katowice
Country 94995 0
Poland
Phone 94995 0
+48322075301
Fax 94995 0
+48322075301
Email 94995 0
[email protected]
Contact person for scientific queries
Name 94996 0
Anna Polak
Address 94996 0
Department of Physical Therapy, Academy of Physical Education, Mikolowska Str. 72A, 40-065 Katowice
Country 94996 0
Poland
Phone 94996 0
+48322075301
Fax 94996 0
+48322075301
Email 94996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The results of individual patient tests will be stored in the electrionics database of the research team. The aggregate results will be subjected to statistical analysis and published in scientific journals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3144Clinical study report  [email protected]



Results publications and other study-related documents

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