ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chronic coronary artery disease

coronary revascularization

Condition category

Condition code

Cardiovascular

Coronary heart disease

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

The control group will be participate in standard cardiac physiotherapy model.

Control group

Active

Outcomes

Primary outcome [1]

Pulmonary function (FVC, FEV1)

Timepoint [1]

pre-surgery and after 4th and 6th day (primary timepoint) after surgery

Primary outcome [2]

chest pain intensity with VAS scale, where: “0” –meant no pain”, and “10”- the strongest pain that one can imagine

Timepoint [2]

pre-surgery and after 4th and 6th day (primary timepoint) after surgery

Primary outcome [3]

physical capacity/mobility with VAS scale, where: “0”- meant walking with orthopaedic aids, and “10”-complete fitness

Timepoint [3]

pre-surgery and after 4th and 6th day (primary timepoint) after surgery

Secondary outcome [1]

fatigue after physical exercises with Borg scale, where: “7”- mean minimum fatigue and “19”-maximum fatigue

Timepoint [1]

done on day 4 and 6 following the surgery

Secondary outcome [2]

difficulties breathing with VAS scale, where: “0”- meant no difficulties, and “10” maximum difficulties (oxygen therapy

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Poznan University School of Physical Education, Gorzow Wielkopolski

Address [1]

Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics committee - Poznan University of Medical Sciences

Ethics committee address [1]

Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu, ul. Bukowska 70, pok A204, 60-812 Poznan

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

01/02/2018

Ethics approval number [1]

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

Dr Malgorzata Chochowska

Address

Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski

Country

Poland

Phone

+48957279222

Fax

chochowska@centrum-kore.pl

Contact person for public queries

Name

Malgorzata Chochowska

Address

Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski

Country

Poland

Phone

+48957279222

Fax

chochowska@centrum-kore.pl

Contact person for scientific queries

Name

Malgorzata Chochowska

Address

Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski

Country

Poland

Phone

+48957279222

Fax

chochowska@centrum-kore.pl

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

No additional documents have been identified.

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