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Trial registered on ANZCTR


Registration number
ACTRN12618001871235
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
16/11/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Breathing training in the process of rehabilitation in patients after myocardial infarction.
Scientific title
Effect of cardiac rehabilitation and inspiratory muscle training on functional status in patient with cardiovascular diseases.
Secondary ID [1] 296182 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction 309827 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308617 308617 0 0
Physiotherapy
Cardiovascular 308620 308620 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were qualified by the physician responsible for the course and interpretation of the test results. Prior to the implementation of the experiment, all subjects were informed about its purpose, manner of conducting and the possibility of resignation at any time during the research project. The respondents gave written consent to participate in the research. In addition, there was an information meeting on the impact of respiratory muscle training on their muscle functions and on lung ventilation.
The subjects were divided into three groups.
Group I: subjects subjected to a cycle of cardiological rehabilitation and inspiratory muscle training (women and men).
Group II: Patients subjected only to the cardiological rehabilitation cycle, in accordance with the standards of cardiological rehabilitation.
Group III: Subjects subjected only to inspiratory muscle training.

Group I and III patients underwent inspiratory muscle training on Respironics Threshold IMT.
At the beginning of the program, each group conducted an educational lecture on the respiratory function and hygiene and breathing support techniques, and all participants of the inspiratory muscle training were additionally lectured combined with the presentation of the device and the training instructor.Inspiratory muscle training was conducted 5 times a week, of which 4 sessions at home, and 1 under the supervision of a physiotherapist at the CREATOR Prevention and Rehabilitation Center in Wroclaw.   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 were carried out, while maintaining the rules consistent with the technique of proper breathing. Training took place in a standing position. After setting the individual resistance, the subjects placed a nose clip and then tightly covered the mouthpiece with the mouth. The inspiratory phase was characterized by a quick, energetic, short and diaphragmatic breath. The exhale was slow, calm, and long and had to last until reaching the RV, because every breath should start from that level. Each subject performed exercises alone on his personal training device. After the initial PImax assessment, an individual level of training load was set. The strength of the inspiratory muscles, in the first measurement, was expressed in kPa, and then it was converted into cm H2O according to the formula 1 kPa = 10.2 cm H2O. Dictated it was a scale placed on the training device. This change allowed calculating the appropriate training load, using the Threshold IMT training device. In the first week, the training load was 30% PImax, and each session lasted 5 minutes, twice a day. The value of the initial load was dictated by the safety conditions of conducting the training. In the following weeks, the load was increased and the duration of exercise was extended during the day (60% PImax, 2x 15min). Each patient kept a participant diary in which recorded the dates and time of training. This diary was checked by the physiotherapist once a week.

Patients from group I and II were subjected to a cardiological rehabilitation cycle, which included interval endurance training on the cycloergometer 3 times a week and general improvement and resistance exercises conducted twice a week. The training took place for 8 weeks in an outpatient setting under medical supervision. During one 45-minute workout, the patient performed cycles: effort for 4 minutes and rest for 2 minutes with a still existing load of 0-5 W. The intensity of exercise gradually increased in the first half of training, and then decreased after reaching peak intensity. Each training session started with a warm-up and ended with relaxation, or 3-minute ride on the unloaded cycloergometer. The training load was calculated individually for each patient, based on the result achieved during the exercise test, and then increased by no more than 10 W every 4 training sessions on the cycling cycloergometer. During the cycloergometer training, the heart rate and arterial blood pressure were monitored at the beginning and end of each workout.
Intervention code [1] 312518 0
Rehabilitation
Comparator / control treatment
Group II was a control group (people from this group had implemented only cardiac rehabilitation, which is the standard after a heart attack in Poland).
Control group
Active

Outcomes
Primary outcome [1] 307626 0
Assesment of inspiratory muscle strength via spirometry by Flowscreen (780, 578, 1.3) Jaeger with a shutter with power unit.
Timepoint [1] 307626 0
Baseline and after 8 weeks.
Primary outcome [2] 307627 0
Assesment of expiratory muscle strength via spirometry by Flowscreen (780, 578, 1.3) Jaeger with a a shutter with power unit.
Timepoint [2] 307627 0
Baseline and after 8 weeks
Primary outcome [3] 307629 0
Assessment of exercise tolerance via stress test on the treadmill (according to the modified Bruce protocol).
Timepoint [3] 307629 0
baseline and after 8 weeks
Secondary outcome [1] 352456 0
Assessment of lower limb strength was tested with the Biodex Multi-Joint 4 Iso-kinetic Dynamometer.
Timepoint [1] 352456 0
Baseline and after 8 weeks
Secondary outcome [2] 353802 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Vital Capacity (VC)
Timepoint [2] 353802 0
Baselina and after 8 weeks
Secondary outcome [3] 353803 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Forced Vital Capacity (FVC)


Timepoint [3] 353803 0
Baseline and after 8 weeks
Secondary outcome [4] 353804 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Forced Expiratory Volume in one second (FEV1)

Timepoint [4] 353804 0
Baseline and after 8 weeks
Secondary outcome [5] 353805 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Forced Expiratory Volume in one second % of Vital Capacity (FEV1%VC)

Timepoint [5] 353805 0
Baseline and after 8 weeks
Secondary outcome [6] 353806 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Peak Expiratory Flow (PEF)

Timepoint [6] 353806 0
Baseline and after 8 weeks
Secondary outcome [7] 353807 0
Assesment of lung function via spirometry by Flowscreen (780, 578, 1.3) Jaeger.
Parameter:
• Maximal Inspiratory Flow (MIF50)
Timepoint [7] 353807 0
Baseline and after 8 weeks

Eligibility
Key inclusion criteria
- Patients after myocardial infarction admitted to the second stage of cardiac rehabilitation
- stable clinical condition,
- not participating in rehabilitation programs within a year from the start of the study
- cardio-respiratory failure (NYHA I and NYHA II)
- giving informed written consent
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- respiratory diseases that significantly reduce respiratory function
- condition after aortic surgery and / or iliac arteries
- condition after vascular damage in the central nervous system
- spinal or pelvic injuries
- requiring chemotherapy
- angina triggered by cardiac rehabilitation
- use of antidepressants
- an acute illness that may affect the performance of the rehabilitation program or worsen during exertion: for example infection, renal failure, hyperthyroidism diabetes
- orthopedic and neurological disorders that lower the mobility (movement capabilities) and the patient's ability to cooperate during the planned training
- mental disorders that prevent contact and cooperation with the patient
- cardio-respiratory failure (NYHA III).

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
Patients were divided into three groups: group I underwent cardiac rehabilitation and additionally trained inspiratory muscles. Group III was only involved in breathing muscle training (patients could not participate in cardiac rehabilitation). Group II was a control group, patients from this group participated only in cardiac rehabilitation which is the standard after myocardial infarction in Poland.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2014
Date of last participant enrolment
Anticipated
Actual
9/01/2015
Date of last data collection
Anticipated
Actual
16/03/2015
Sample size
Target
145
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 20891 0
Poland
State/province [1] 20891 0

Funding & Sponsors
Funding source category [1] 300772 0
University
Name [1] 300772 0
University School of Physical Education in Wroclaw
Country [1] 300772 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] 300316 0
None
Name [1] 300316 0
Address [1] 300316 0
Country [1] 300316 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301555 0
Senacka Komisja ds. Etyki Badan Naukowych przy Akademii Wychowania Fizycznego we Wroclawiu
Ethics committee address [1] 301555 0
Ethics committee country [1] 301555 0
Poland
Date submitted for ethics approval [1] 301555 0
11/11/2013
Approval date [1] 301555 0
19/12/2013
Ethics approval number [1] 301555 0

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

Contacts
Principal investigator
Name 87370 0
Dr Monika Kurzaj
Address 87370 0
Monika Kurzaj, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland
Country 87370 0
Poland
Phone 87370 0
+48 696 597 975
Fax 87370 0
Email 87370 0
monika.kurzaj@awf.wroc.pl
Contact person for public queries
Name 87371 0
Monika Kurzaj
Address 87371 0
Monika Kurzaj, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland
Country 87371 0
Poland
Phone 87371 0
+48 696 597 975
Fax 87371 0
Email 87371 0
monika.kurzaj@awf.wroc.pl
Contact person for scientific queries
Name 87372 0
Monika Kurzaj
Address 87372 0
Monika Kurzaj, PhD
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw, Poland
Country 87372 0
Poland
Phone 87372 0
+48 696 597 975
Fax 87372 0
Email 87372 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?
Requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
65Ethical approval    376078-(Uploaded-31-10-2018-21-43-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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