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Trial registered on ANZCTR


Registration number
ACTRN12619000473167
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
22/03/2019
Date last updated
22/03/2019
Date data sharing statement initially provided
22/03/2019
Date results information initially provided
22/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breathing training in the process of rehabilitation after treatment for breast cancer.
Scientific title
The impact of inspiratory muscle training on the functional state of the respiratory system and respiratory muscles of women after treatment for breast cancer.
Secondary ID [1] 297309 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 311414 0
Condition category
Condition code
Cancer 310040 310040 0 0
Breast
Physical Medicine / Rehabilitation 310041 310041 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects will be informed about its purpose, manner of conducting and the possibility of resignation at any time during the research project. The respondents will give written consent to participate in the research. In addition, there will be an information meeting on the impact of respiratory muscle training on their muscle functions and on lung ventilation.
Study group (SG):
The research will cover women treated for breast cancer associated in the Wroclaw Femina Fenix Association, regularly participating in general gymnastics since the end of oncological treatment.
Control group (CG):
The control group will consist healthy women, never treated for neoplastic disease - students of the University of the Third Age at the University of Physical Education in Wroclaw, who also regularly participated in general improvement exercises.

Several women women (both SG and CG) will be involved in inspiratory muscle training using the Treshold device (Respironics Threshold IMT). At the beginning of the program (1 day of training), each group will conduct by physiotherapist an educational lecture (1 h) on the respiratory function and hygiene and breathing support techniques, and all participants of the inspiratory muscle training will additionally lecture combine with the presentation of the device and the training instructor Inspiratory muscle training will conduct 5 times a week, of which 4 sessions at home, and 1 under the supervision of a physiotherapist. Inspiratory muscle training lasted 8 weeks. Before starting the training program, instructional classes on the proper technique of performing exercises with the Threshold IMT apparatus will carry out, while maintaining the rules consistent with the technique of proper breathing.
Training take place in a standing position. After setting the individual resistance, the subjects place a nose clip and then tightly cover the mouthpiece with the mouth. The inspiratory phase will characterized by a quick, energetic, short and diaphragmatic breath. The exhale will slow, calm, and long and will to last until reaching the RV (residual volume), because every breath should start from that level. Each subject perform exercises alone on his personal training device. After the initial PImax assessment, an individual level of training load will set. The strength of the inspiratory muscles, in the first measurement, was expressed in kPa, and then it will be convert into cm H2O according to the formula 1 kPa = 10.2 cm H2O. This change allowed calculating the appropriate training load, using the Threshold IMT training device. In the first week, the training load will be 30% PImax, and each session last 5 minutes, twice a day. The value of the initial load will dictate by the safety conditions of conducting the training. In the following weeks, the load will be increased and the duration of exercise was extended during the day (60% PImax, 2x 15min). Each patient keep a participant diary in which recorded the dates and time of training. This diary is going to check by the physiotherapist once a week.







Intervention code [1] 313562 0
Rehabilitation
Comparator / control treatment
Control group (CG):
The control group will consist of 13 healthy women, never treated for neoplastic disease - students of the University of the Third Age at the University of Physical Education in Wroclaw, who also regularly participated in general improvement exercises.
Control group
Active

Outcomes
Primary outcome [1] 318940 0
Assesment of inspiratory muscle strength via spirometry by Flowscreen (780, 578, 1.3) Jaeger with a shutter with power unit.
Timepoint [1] 318940 0
Baseline and after 8 weeks.
Primary outcome [2] 318941 0
Assesment of expiratory muscle strength via spirometry by Flowscreen (780, 578, 1.3) Jaeger with a a shutter with power unit
Timepoint [2] 318941 0
Baseline and after 8 weeks
Secondary outcome [1] 366479 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Vital Capacity (VC)
Timepoint [1] 366479 0
Baselina and after 8 weeks
Secondary outcome [2] 366480 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Forced Vital Capacity (FVC)
Timepoint [2] 366480 0
Baseline and after 8 weeks
Secondary outcome [3] 366481 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Forced Expiratory Volume in one second (FEV1)
Timepoint [3] 366481 0
Baseline and after 8 weeks
Secondary outcome [4] 366482 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Peak Expiratory Flow (PEF)
Timepoint [4] 366482 0
Baseline and after 8 weeks
Secondary outcome [5] 366483 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Maximal Expiratory Flow (MEF)
Timepoint [5] 366483 0
Baseline and after 8 weeks

Eligibility
Key inclusion criteria
Study group (GB):
The study will involve women treated for breast cancer associated in the Wroclaw Femina Fenix Association, regularly participating in general gymnastics since the end of oncological treatment.
The control group consisted of 13 healthy women, never treated for cancer
Minimum age
59 Years
Maximum age
76 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- respiratory system diseases
- smoking cigarettes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
The persons tested in this project will be divided into two groups. One will be women after treatment for breast cancer, the other one who did not have cancer. In both groups, according to randomization, there will be a division into people who will participate in inspiratory muscle training and those who will not practice.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21253 0
Poland
State/province [1] 21253 0

Funding & Sponsors
Funding source category [1] 301872 0
University
Name [1] 301872 0
University School of Physical Education in Wroclaw
Address [1] 301872 0

al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw,
Country [1] 301872 0
Poland
Primary sponsor type
Individual
Name
Monika Kurzaj
Address
Monika Kurzaj PhD
Department of Physiotherapy in Internal Diseases
University School of Physical Education in Wroclaw, Poland
al.Ignacego Jana Paderewskiego 35
51-612 Wroclaw,
Country
Poland
Secondary sponsor category [1] 301622 0
None
Name [1] 301622 0
Address [1] 301622 0
Country [1] 301622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302564 0
Senacka Komisja ds. Badan Naukowych przy Akademii Wychowania Fizycznego we Wroclawiu
Ethics committee address [1] 302564 0
Senacka Komisja ds. Badan Naukowych
University School pf Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw

Ethics committee country [1] 302564 0
Poland
Date submitted for ethics approval [1] 302564 0
08/01/2018
Approval date [1] 302564 0
08/03/2018
Ethics approval number [1] 302564 0

Summary
Brief summary
The objective of this study is to assess the efficacy of and without inspiratory muscle training (IMT) on pulmonary function, inspiratory muscle strength in patients after breast cancer.
All examined women before and after training will be tested: maximal inspiratory and expiratory pressure (PImax and PEmax) values and lung function.
The first group will be women after treatment for breast cancer (about 48), the second group will be healthy women (n = 13). In each group, after randomized selection, half of the people will participate in the 8-week inspiratory muscle training on the Threshold device.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90670 0
Dr Monika Kurzaj
Address 90670 0
Monika Kurzaj, PhD University School of Physical Education al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw, Poland
Country 90670 0
Poland
Phone 90670 0
+48 696 597 975
Fax 90670 0
Email 90670 0
monika.kurzaj@awf.wroc.pl
Contact person for public queries
Name 90671 0
Dr Monika Kurzaj
Address 90671 0
Monika Kurzaj, PhD University School of Physical Education al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw, Poland
Country 90671 0
Poland
Phone 90671 0
+48 696 597 975
Fax 90671 0
Email 90671 0
monika.kurzaj@awf.wroc.pl
Contact person for scientific queries
Name 90672 0
Dr Monika Kurzaj
Address 90672 0
Monika Kurzaj, PhD University School of Physical Education al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw, Poland
Country 90672 0
Poland
Phone 90672 0
+48 696 597 975
Fax 90672 0
Email 90672 0
monika.kurzaj@awf.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately after the publication of the material in the journal. End-date of availability: 6 months from publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
IPD will be available by e- mail the principal investigator: monika.kurzaj@awf.wroc.pl
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1435 0
Ethical approval
Citation [1] 1435 0
Link [1] 1435 0
Email [1] 1435 0
Other [1] 1435 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary