Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001315707
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
26/11/2013
Date last updated
15/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The assessment of changes of respiratory parameters and bioelectrical activity of accessory respiratory muscles depending on applied breathing stimulation in patients after ischemic stroke
Scientific title
In patients after ischemic stroke, does different type of applied breathing stimulation influence changes in respiratory parameters and bioelectrical activity of accessory respiratory muscles?
Secondary ID [1] 283621 0
none
Universal Trial Number (UTN)
U1111-1149-3696
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients after ischemic stroke 290493 0
Condition category
Condition code
Stroke 290887 290887 0 0
Ischaemic
Physical Medicine / Rehabilitation 290888 290888 0 0
Physiotherapy
Respiratory 290889 290889 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main goal of this project is to perform an objective evaluation of the influence of selected interventions on respiratory function in stroke patients. A single intervention stimulating respiratory system will be performed in each person depending on the assigned group. All stimulations will concentrate on intensifying the work of diaphragm and intercostal muscles and will be performed with patients lying on their back with their lower and upper limbs slightly flexed and resting on special rollers and wedges. Due to that, the diaphragm does not have to work directly against gravity. Additionally, lower limb flexion leads to relaxation of the abdominal wall and improvement of inspiration effectiveness.

The target group will be divided into a study group (Group A – stimulation of breathing using a proprioceptive neuromuscular facilitation method, PNF) and a control group (Group B - patient positioning). Each intervention will be administered to participants once by the same person - a physiotherapist who is also a certified PNF therapist.

Group A will be subjected to breathing stimulation according to the proprioceptive neuromuscular facilitation method. Proprioceptive neuromuscular facilitation (PNF) is a neuromuscular treatment method for restoring movement and mobility using sensory inputs to direct motions. During the PNF breathing stimulation, physiotherapist places his hands on the epigastric region, below the costal margins. Therapist instructs the exercising person with regard to the moment of deep expiration phase, at the end of which he applies optimal pressure (stretch) directed toward the diaphragm, simultaneously commanding the patient to inhale. Slight resistance, however not preventing inspiration, is applied when taking a breath. This action is repeated thrice, in two series, at time intervals (1 minute interval), which prevents hyperventilation [3 stimulated breaths in – 1 minute interval – 3 stimulated breaths in]. Subsequently, the therapist moves his hands to the region of inferior costal arches of the chest and repeats the stimulation [and again: 3 stimulated breaths in – 1 minute interval – 3 stimulated breaths in].

Intervention in Group B will involve lying free in a supine position, with lower and upper limbs slightly bent placing a special roller under the lower limbs. This will allow to investigate exclusively the influence of diaphragm position, which in this case is placed at optimal height, gaining greater inspiratory dimension. Patients stay in this position for 15 minutes.
Intervention code [1] 288315 0
Rehabilitation
Comparator / control treatment
one control group (Group B).
Control group
Active

Outcomes
Primary outcome [1] 290929 0
The electromyographic examination of accessory respiratory muscles by means of surface EMG.
Timepoint [1] 290929 0
the date of examination - immediately after all examinations are completed for each patient
Secondary outcome [1] 305615 0
The spirometric evaluation of ventilation parameters by spirometer.
Timepoint [1] 305615 0
the date of examination - immediately after all examinations are completed for each patient
Secondary outcome [2] 305616 0
Evaluation of pulse oximetry by pulse oximeter.
Timepoint [2] 305616 0
the date of examination - immediately after all examinations are completed for each patient

Eligibility
Key inclusion criteria
1. Ischemic stroke (at least 6 months before the examination)
2. Subject's consent to participate in the study,
3. Attending physician's consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- lack of subject's consent,
- lack of attending physician's consent,
- sensory aphasia,
- past heart attack,
- implanted cardiac stimulator,
- past/present respiratory system diseases,
- severe abdominal obesity,

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by appropriate website (http://www.random.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2013
Actual
2/12/2013
Date of last participant enrolment
Anticipated
15/03/2015
Actual
15/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5622 0
Poland
State/province [1] 5622 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 288267 0
University
Name [1] 288267 0
Wroclaw Medical University
Country [1] 288267 0
Poland
Primary sponsor type
University
Name
Wroclaw Medical University
Address
Wybrzeze L. Pasteura 1,
50-367 Wroclaw
Poland
Country
Poland
Secondary sponsor category [1] 287021 0
None
Name [1] 287021 0
none
Address [1] 287021 0
none
Country [1] 287021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290165 0
Bioethics Committee of the Wroclaw Medical University
Ethics committee address [1] 290165 0
Ethics committee country [1] 290165 0
Poland
Date submitted for ethics approval [1] 290165 0
04/12/2012
Approval date [1] 290165 0
21/12/2012
Ethics approval number [1] 290165 0
KB – 867/2012

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

Contacts
Principal investigator
Name 44294 0
Dr Lucyna Slupska
Address 44294 0
Wroclaw Medical University
Faculty of Health Science
Department of Physiotherapy
Grunwaldzka 2,
50-355 Wroclaw
Country 44294 0
Poland
Phone 44294 0
+48695401515
Fax 44294 0
Email 44294 0
[email protected]
Contact person for public queries
Name 44295 0
Lucyna Slupska
Address 44295 0
Wroclaw Medical University
Faculty of Health Science
Department of Physiotherapy
Grunwaldzka 2,
50-355 Wroclaw
Country 44295 0
Poland
Phone 44295 0
+48695401515
Fax 44295 0
Email 44295 0
[email protected]
Contact person for scientific queries
Name 44296 0
Lucyna Slupska
Address 44296 0
Wroclaw Medical University
Faculty of Health Science
Department of Physiotherapy
Grunwaldzka 2,
50-355 Wroclaw
Country 44296 0
Poland
Phone 44296 0
+48695401515
Fax 44296 0
Email 44296 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImmediate effects of the respiratory stimulation on ventilation parameters in ischemic stroke survivors: A randomized interventional study (CONSORT).2019https://dx.doi.org/10.1097/MD.0000000000017128
N.B. These documents automatically identified may not have been verified by the study sponsor.