Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201703002101365 Date of Approval: 13/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of abdominal exercises on sternal separation after open heart surgery
Official scientific title Effect of Trunk Stabilizing Exercises on Sternal Separation In Sternal Dehiscence after Coronary Artery Bypass Grafting
Brief summary describing the background and objectives of the trial Problems associated with sternal healing after open heart surgery are an important issue for physical therapists. Upper limb exercises are usually prescribed in the inpatient cardiac rehabilitation after surgery, but no data is available as regards to its effect on sternal motion. The aim of the present study was to evaluate the effects of a program of graduated trunk stabilization (abdominal muscle contraction with loaded and unloaded upper limb exercises) on sternal separation, pain, and ADL in cardiac patients with acute sternal instability after coronary artery bypass grafting (CABG)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied after recent open heart surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/02/2014
Actual trial start date 03/03/2014
Anticipated date of last follow up 20/04/2014
Actual Last follow-up date 27/04/2014
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL not yet published
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Dynamic adaptive random allocation ( minimizing) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group the study group performed trunk stabilizing exercises that began from the 7th day postoperatively 5-10 repetitions, 2 sessions daily for four weeks. Three sessions per week was conducted at the Physical Therapy Department at National Heart Institute, which the other sessions were conducted at home four weeks The program consisted of contraction for the abdominal muscles actively by the patient from supine position with an inverted -U- shaped hydrotherapy foam placed under the scapula, to decrease sternal separation, with hold for at least 6-10 seconds and about 10 repetitions, this was followed by abdominal contraction from sitting position, then contraction with loaded bilateral upper limb elevation 20
Control Group traditionally inpatient physical therapy program Both groups received the program from the 1st day postoperative for about 30 minutes, two sessions daily, three times per week 5 weeks( one inpatient program and 4 weeks outpatient Patients in both groups, also received TENS from the third day postoperative parasternally at the subclavicular region on either side of the incision, about 2-3 cm from the suture line, for about additional 20 minutes to relive incisional pain. Infrared was also applied on the upper trapezius muscle for an additional ten minutes to relieve muscle spasm which occurs after CABG surgery. Patients 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-having acute sternal dehiscence assessed clinically by sternal instability testing which was conducted from sitting position with the index and middle fingers of the investigator at both sides of sternal incision, the patient then rotate the head to the right and then to the left side. There was a palpable sternal motion and separation with audible clicking sound, which indicated that the patient has sternal dehiscence. Sternal separation assessment was confirmed through ultrasound done by a specialist cardiologist. All of the patients had risk factors affecting sternal incision healing if they had unstable cardiovascular status such as systolic blood pressure less than 100 mmHg or more than 180 mmHg Mean arterial blood pressure less than 60 mmHg or more than 110mmHg Arrhythmias Marked shoulder condition that could preclude them from participation in trunk stabilizing exercises. 45 Year(s) 57 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/01/2014 Ethical Commitee of National Heart Institute
Ethics Committee Address
Street address City Postal code Country
Imbaba Giza governorate 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sternal separation measured by ultrasonography one week after the end of the trail
Secondary Outcome pain measured by visual analogue scale during certain movements one week after the end of the trail
Secondary Outcome ability to do activities of daily living performance scale one week after the end of the trail
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Heart Institute, cardiac surgery department Imbaba, Giza Giza governorate 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Heart Institute Imbaba, Giza Giza governorate 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Sherin H M Mehani Benisuef Elgadata, street no 18 Benisuef 62511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
ElSayed E. Elsayed Faysal street Giza governorate 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherin Mehani sherinhassin@yahoo.com 01003378217 Benisuef Elgadata, street no 18
City Postal code Country Position/Affiliation
Benisuef governorate 62511 Egypt
Role Name Email Phone Street address
Public Enquiries Sherin Mehani sherinhassin@yahoo.com 01003378217 Benisuef Elgadata, street no 18
City Postal code Country Position/Affiliation
Benisuef governorate 62511 Egypt
Role Name Email Phone Street address
Scientific Enquiries Sherin Mehani sherinhassin@yahoo.com 01003378217 Benisuef Elgadata, street no 18
City Postal code Country Position/Affiliation
Benisuef governorate 62511 Egypt
REPORTING
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