Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000470291
Ethics application status
Approved
Date submitted
18/02/2018
Date registered
3/04/2018
Date last updated
3/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of myofascial release techniques in patients after coronary revascularization.
Scientific title
Effects of myofascial release techniques on pulmonary function in patients after coronary artery bypass grafting (CABG) and off-pump coronary artery bypass grafting (OPCAB) surgery.
Secondary ID [1] 294087 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic coronary artery disease 306653 0
coronary revascularization 306654 0
Condition category
Condition code
Cardiovascular 305755 305755 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 305812 305812 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomized into two groups: A, B. Group A (control) and Group B will participate in standard cardiac physiotherapy model. In Group B, from 3 to 6 day after surgery, additionally myofascial release techniques (MFR) will be performed (with a physiotherapist, one on one, face to face). MFR will include Carol Manheim MFR techniques. Interventions will embrace structures of SFL (Superficial Front Line, myofascial line according to Myers) and LL (Lateral Line, myofascial line according to Myers) – within the area of chest wall and abdominal wall. MFR techniques will be performed once a day for 30 minutes. Standard cardiac physiotherapy model includes: exercises with a physiotherapist, one on one, face to face, 3-5 times per day, each time for 15-30 minutes (depending on the level of cardiopulmonary capacity of each patient – the bigger the failure the more frequent and shorter exercising periods and exercises performed by patients themselves (breathing, coordinating and walking - patients will note total time spent on each exercise per day in a diary). Required target intensity of exercises will be from 20 to 40 increase in heart rate, HR (HR: min. increase 20; max. increase 40). Between day 1 and 3 there will be a continuing monitoring of arterial blood pressure (continuing vinous blood pressure, as well as blood pressure measurement with a cuff every 15-30 min), heart systolic function (HR: min. increase 20; max. increase 40 during exercises) and saturation (SaO2:85% – threshold value, need for intubation; SaO2:89-94% – exercises 5x a day assisted by a physiotherapist; SaO2:95-100% – exercises 3x a day assisted by a physiotherapist).Physical therapist will administrate the intervention.
Intervention code [1] 300358 0
Rehabilitation
Intervention code [2] 300359 0
Treatment: Other
Comparator / control treatment
The control group will be participate in standard cardiac physiotherapy model.
Control group
Active

Outcomes
Primary outcome [1] 304826 0
Pulmonary function (FVC, FEV1)
Timepoint [1] 304826 0
pre-surgery and after 4th and 6th day (primary timepoint) after surgery
Primary outcome [2] 304827 0
chest pain intensity with VAS scale, where: “0” –meant no pain”, and “10”- the strongest pain that one can imagine
Timepoint [2] 304827 0
pre-surgery and after 4th and 6th day (primary timepoint) after surgery
Primary outcome [3] 304828 0
physical capacity/mobility with VAS scale, where: “0”- meant walking with orthopaedic aids, and “10”-complete fitness
Timepoint [3] 304828 0
pre-surgery and after 4th and 6th day (primary timepoint) after surgery
Secondary outcome [1] 343312 0
fatigue after physical exercises with Borg scale, where: “7”- mean minimum fatigue and “19”-maximum fatigue
Timepoint [1] 343312 0
done on day 4 and 6 following the surgery
Secondary outcome [2] 343313 0
difficulties breathing with VAS scale, where: “0”- meant no difficulties, and “10” maximum difficulties (oxygen therapy
Timepoint [2] 343313 0
baseline (before the surgery) and after 4th and 6th day after surgery

Eligibility
Key inclusion criteria
- Patients after CABG or OPCAB
- No systemic contraindications to undertake the proposed forms of exercise
- Written consent to participate in a clinical trial
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
aneurysm
tumors (also heart tumors)
cardiac pacemaker or implantable cardioverter defibrillator
sternum instability
post-operative wound infection
neurologic diseases
mental diseases
at least 3 documented myocardial infarctions
smoking > 40 cigarettes per day
BMI > 35

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 9599 0
Poland
State/province [1] 9599 0

Funding & Sponsors
Funding source category [1] 298716 0
University
Name [1] 298716 0
Poznan University School of Physical Education, Gorzow Wielkopolski
Country [1] 298716 0
Poland
Primary sponsor type
University
Name
Poznan University School of Physical Education, Gorzow Wielkopolski
Address
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country
Poland
Secondary sponsor category [1] 297890 0
None
Name [1] 297890 0
Address [1] 297890 0
Country [1] 297890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299663 0
Bioethics committee - Poznan University of Medical Sciences
Ethics committee address [1] 299663 0
Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu, ul. Bukowska 70, pok A204, 60-812 Poznan
Ethics committee country [1] 299663 0
Poland
Date submitted for ethics approval [1] 299663 0
Approval date [1] 299663 0
01/02/2018
Ethics approval number [1] 299663 0
171/18

Summary
Brief summary
The goal of the study is to assess and compare changes in pulmonary function, pain level, functional capacity, breathing disorders, fatigue in patients after CABG or OPCAB. Study participants will be patients after CABG or OPCAB recruited from the Department of Cardiac Surgery, Multidisciplinary Urban Hospital in Poznan. 80 patients will be randomised into 2 groups - A and B. Group A (control) will participate in standard cardiac physiotherapy model. In Group B, from 3 to 6 day after surgery, additionally myofascial release techniques will be performed. Standard cardiac physiotherapy model includes: exercises with a physiotherapist 3-5 times per day, each time for 15-30 minutes (depending on the degree of circulatory and respiratory capacity of the patient - the greater the failure, the more often and shorter time of the exercises) and exercises performed by the patient alone (respiratory, coordination and walking exercises). During first 3 days after surgery there will be a constant monitoring of blood pressure (permanent venous measurement and cuff measurement every 15-30 minutes), heart rate (HR: minimum increase - 20; maximum increase - 40) and saturation (SaO2: 85% - lower limit, need for intubation, SaO2: 89-94% - exercises 5 times with a physiotherapist, SaO2: 95-100% - exercises 3 times with a physiotherapist). Before and after 4 and 6 days after surgery patients will undergo the following examinations: pulmonary function (FVC and FEV1), pain level, breathing disorders, functional capacity - with VAS, fatigue after exercises - with Borg scale. Statistical analysis will be performed with the use of Statistica 10 software. Study has been approved by the research Bioethics Comittee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81218 0
Dr Malgorzata Chochowska
Address 81218 0
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country 81218 0
Poland
Phone 81218 0
+48957279222
Fax 81218 0
Email 81218 0
[email protected]
Contact person for public queries
Name 81219 0
Dr Malgorzata Chochowska
Address 81219 0
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country 81219 0
Poland
Phone 81219 0
+48957279222
Fax 81219 0
Email 81219 0
[email protected]
Contact person for scientific queries
Name 81220 0
Dr Malgorzata Chochowska
Address 81220 0
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country 81220 0
Poland
Phone 81220 0
+48957279222
Fax 81220 0
Email 81220 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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