Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001296325
Ethics application status
Approved
Date submitted
2/07/2015
Date registered
8/09/2017
Date last updated
9/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Expiratory muscle training in chronic heart failure
Scientific title
The pulmonary effects of expiratory muscle training device Threshold PEP to decrease dyspnoea symptoms in patients with systolic heart failure.
Secondary ID [1] 292367 0
None
Universal Trial Number (UTN)
U1111-1171-7902
Trial acronym
EMTHF
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
systolic chronic heart failure 295509 0
Condition category
Condition code
Cardiovascular 295767 295767 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 303275 303275 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient was advised to undertake a 10 week expiratory muscles training program with Threshold Positive expiratory preassure (Treshold PEP), which he was taught by a physiotherapist in the hospital and with which he continued at home. The Treshold PEP is a small respiratory device to which the patient breathes against resistance and strenghtens his expiratory muscles. This device is advised to be used half an hour every day for the duration of 10 weeks. Every patient recieves a plan based on their initial examination results. All patients, who refused expiratory muscle training were, with approval, included in the control group - it is consecutive group of patients.
These patients went through identical initial and leaving examinations: anamnesis, clinical examination, spirometry, plethysmography, blood gas levels were determined and the patients also completed the modified Medical Research Council dyspnea questionnaires. A six-minute walk test (6-MWT) was performed with patients, also, the chest parameters in the mesosternale and xiphosternale level were measured.
Intervention code [1] 292247 0
Rehabilitation
Intervention code [2] 292248 0
Lifestyle
Intervention code [3] 298538 0
Treatment: Devices
Comparator / control treatment
All of this information was collected during July 2017 - September 2017. The control group is without any expiratory muscle training - the do not use the treshold PEP, but after the 10 weeks, they are evaluated with the use of the same methods (spirometry, bodyplethismography) as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 295475 0
Change in subjective perception of dyspnoea scale (mMRC scale), assessed by a 4 point numerical rating scale.
Timepoint [1] 295475 0
This study is starting on July 10 2017 and last until September 24 2017. On the July 10 the patients start to use the Treshold PEP and they stop using it after 10 weeks, which is September 24. Change of dyspnea on the modified medical research council dyspnea scale (mMRC scale) is assessed in each participant in the beginning of this study and at 10 weeks.
Secondary outcome [1] 315661 0
Change in maximal expiratory preassure, assessed by body plethysmograhy.
Timepoint [1] 315661 0
In the beginning of this study, every patient undergoes a series of tests. Based on the results, every patient gets an individual plan of the use of the PEP device. After the 10 week training the use of PEP is done and the patient takes the same tests as on the start.
Secondary outcome [2] 337417 0
Change in chest expansion in cm, assessed by meter.
Timepoint [2] 337417 0
In the beginning of this study, every patient undergoes a series of tests. Based on the results, every patient gets an individual plan of the use of the PEP device. After the 10 week training the use of PEP is done and the patient takes the same tests as on the start.
Secondary outcome [3] 337818 0
Change in quality of life, assessed using the Minnesota Living with Heart Failure Questionnaire.
Timepoint [3] 337818 0
After the 10 week programme, the patient answeres a questionare, where he states the change.

Eligibility
Key inclusion criteria
systolic heart failure all etiology
New York Heart Association (NYHA) II-III
ejection fraction of the left ventricle (EF LV) less than 45%
patients without lung diseases
Minimum age
No limit
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients can not have uncompensated heart failure, chronic lung disease or change of medication during the intervention.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/07/2017
Date of last participant enrolment
Anticipated
Actual
10/07/2017
Date of last data collection
Anticipated
24/09/2017
Actual
10/05/2018
Sample size
Target
22
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 7019 0
Czech Republic
State/province [1] 7019 0
South-Moravian region

Funding & Sponsors
Funding source category [1] 291592 0
Hospital
Name [1] 291592 0
University Hospital Brno
Country [1] 291592 0
Czech Republic
Funding source category [2] 296918 0
Hospital
Name [2] 296918 0
University Hospital Brno
Country [2] 296918 0
Czech Republic
Primary sponsor type
Hospital
Name
University Hospital Brno
Address
Jihlavska 20
Brno 62500
Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 295962 0
None
Name [1] 295962 0
None
Address [1] 295962 0
None
Country [1] 295962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293124 0
Multicentre and local ethical committee of University Hospital Brno
Ethics committee address [1] 293124 0
Jihlavska 20
62500 Brno
Czech Republic
Ethics committee country [1] 293124 0
Czech Republic
Date submitted for ethics approval [1] 293124 0
09/04/2014
Approval date [1] 293124 0
11/06/2014
Ethics approval number [1] 293124 0
378/2007

Summary
Brief summary
The patients with chronic heart failure (CHF) suffer from low exercise tolerance, dyspnea and increased fatigue. The quality of life is very low because of the symptoms accompanying the CHF. The methodology of respiration therapy by means of any expiratory aids in patients with CHF has not yet been described in foreign countries. The expiratory muscle training with the treshold PEP device at home will lead to the improvement of the quality of life.
The main intention of this study is to find a way how to effectively, cheaply and easily minimize the consecuences of heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58578 0
Mr Filip Dosbaba
Address 58578 0
University Hospital Brno
Jihlavska 20
Brno 62500
Czech Republic
Country 58578 0
Czech Republic
Phone 58578 0
+420532233442
Fax 58578 0
Email 58578 0
[email protected]
Contact person for public queries
Name 58579 0
A/Prof Ondrej Ludka
Address 58579 0
University Hospital Brno
Jihlavská 20
Brno 62500
Czech Republic
Country 58579 0
Czech Republic
Phone 58579 0
+420532233123
Fax 58579 0
Email 58579 0
[email protected]
Contact person for scientific queries
Name 58580 0
A/Prof Ondrej Ludka
Address 58580 0
University Hospital Brno
Jihlavská 20
Brno 62500
Czech Republic
Country 58580 0
Czech Republic
Phone 58580 0
+420532233123
Fax 58580 0
Email 58580 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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