Trial no.:	PACTR202304921938624	Date of Approval:	11/04/2023
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Exercise training for sternal instability after coronary artery bypass grafting.

Official scientific title

Comparative Study of two Rehabilitation Protocols in Acute sternal dehiscence after coronary artery bypass grafting.

Brief summary describing the background and objectives of the trial

Sternal instability is defined as abnormal motion of the sternum associated with crepitus or a clicking sensation and pain during activities of daily living performance, as a result of the fracturing or failure of the sternal wires between the two halves of the sternum. When this occurs in the early post-operative period (about two weeks), it is termed dehiscence, and when it is chronic, it is termed sternal instability (Robicsek et al., 2000). Sternal separation may be partial or total, and most commonly occurs in the lower third due to a decreased blood supply (Moore ., 2006). Purpose of the study The purpose of the study is to evaluate the effect that adding graduated upper limb exercises to the usual inpatient cardiac rehabilitation programme after coronary artery bypass grafting on sternal separation, pain, and activities of daily living performance in patients suffering from sternal dehiscence.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Exercise training Sternal separation CABG

Disease(s) or condition(s) being studied

Cardiology

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Rehabilitation

Anticipated trial start date

14/03/2023

Actual trial start date

15/04/2023

Anticipated date of last follow up

20/05/2023

Actual Last follow-up date

21/05/2023

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

40

Recruitment status

Completed

Publication URL

the protocol is not published on any URL

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	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Graduated upper arm exercise using abdominal muscle contraction plus traditional cardiac rehabilitat	three times per week	one month	Group A (study group)consisted of 20 patients (11 men and 9 women) who received the usual inpatient cardiac rehabilitation programme that began from the first post-operative day, using incentive spirometry, shoulder active range of motion, a graduated walking programme, and therapeutic modalities such as transcutaneous electrical nerve stimulation (TENS), infrared and vibration. This group also received graduated upper limb exercises from the seventh post-operative day, to be performed three times per week for four consecutive weeks, in addition to the same inpatient rehabilitation programme. Graduated upper limb exercises Only patients in Group A, the study group, performed graduated upper limb exercises that began on the seventh post-operative day. Each exercise was performed with 5-10 repetitions during two sessions daily for four weeks. Three sessions per week were conducted at the Physical Therapy Department of the National Heart Institute, while the other sessions were conducted as a home programme at their prescribed heart rate. During home programme, patients used diaries to record their exercises and any noted comments. The programme consisted of active contraction of the abdominal muscles from a supine position with an inverted U-shaped hydrotherapy foam placed under the scapula, to decrease sternal separation, to be held for at least 6-10 seconds and with about 10 repetitions. This was followed by abdominal contractions from a sitting position and contractions with loaded bilateral upper limb elevation, using a weight of about 0.5 kg (5-10 repetitions). This was followed by contractions with unloaded bilateral upper limb elevation, then unilateral unloaded elevation followed by unilateral loaded elevation. The upper limb elevation should be limited with the onset of a feeling of pulling on the incision or mild pain. Patients were instructed to keep their elbows close to the body during elevation (23). This sequence was chosen according to the previous s	20
Control Group	Traditional inpatient cardiac rehabilitation program	three times per week	one month	Inpatient cardiac rehabilitation programme Both groups started the programme from the first post-operative day, to be performed for about 30 minutes per session, with two sessions daily three times per week, as described by O'Sullivan and Schmitz (21). Heart rate was monitored and was not allowed to exceed 30 beats per minute above the resting heart rate, using ECG monitoring in the ICU unit and then using ECG telemetry when the patient was transferred to a ward bed. Patients in both groups also received TENS ( 80 Hz) starting on the third post-operative day, applied 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 (22). Infrared was also applied on the upper trapezius muscle for an additional 10 minutes to relieve the muscle spasms which occur after CABG surgery. Patients were also instructed to take deep breaths using incentive spirometry in the form of four sets. Each set consisted of 10 deep breaths for a total of 40 deep breaths, with a hold at the end of inspiration, followed by huffs and coughs with the support of pillows at the incision. Patients in both groups were also instructed to follow sternal precautions supported by Cahalin et al. (3) such as avoiding pushing or pulling, not assuming a position of lying on the side, lifting no more than 10 pounds of weight and not reaching behind the back.	20	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1- Patients who were included in the study had acute sternal dehiscence assessed clinically by sternal instability testing 2- Sternal separation assessment was confirmed through ultrasound performed by a specialist cardiologist. 3- All of the patients had risk factors that affected sternal incision healing.	1- Patients were excluded if they had unstable cardiovascular status such as a systolic blood pressure less than 100 mmHg or more than 180 mmHg, a mean arterial blood pressure less than 60 mmHg or more than 110 mmHg 2- arrhythmias 3- marked shoulder condition that could preclude them from participating in the exercise program.	Middle Aged: 45 Year(s)-64 Year(s)	50 Year(s)	60 Year(s)	Both

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

11/09/2022

Faculty of Physical Therapy Cairo University Research Ethical Committee

Ethics Committee Address
Street address	City	Postal code	Country
Ben El-Sarayat Traffic, Ad DOQI, gIZA dISTRICT	Giza Governorate	12511	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Sternal separation Sternal separation was measured with an ultrasound unit for each patient before and after the study, by a specialist who was blinded to patient allocation groups. Patients were measured in both a supine lying and long sitting position, with the head of the treatment couch at a 30-degree inclination. The region of the greatest instability along the sternum was identified using sternal instability testing and the skin was marked to give a reference point for all measurements. The transverse direction between the two sections of the sternum was measured in millimetres.	before and after one month
Secondary Outcome	Pain Pain was measured before and after the study using a visual analogue scale. The pain was rated by the patient while he or she performed the following tasks: rotating the trunk, swinging the arms when walking, moving from a sitting to standing position, moving from a supine to sitting position, suddenly losing footing, coughing, and reaching above shoulder height (8). On the posterior aspect of the ruler, patients scored their pain during task performance by moving the mobile bar attached to the ruler up or down such that the red line determined their pain level. On the anterior aspect of the ruler, pain was scored in mm using the red line of the mobile bar, to match the point selected by the patient on the posterior aspect. This method was employed to avoid pain over- or underestimation.	before and after one month
Secondary Outcome	ADL performance The ADL score was determined by adding the achieved points. The patients were asked about their ability to perform the activities described above. If he or she could do the activity, this was scored as one point, and if he or she could not do the activity, it was scored as zero.	before and after one month

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
recruited from the Cardiac Surgery Department at the National Heart Institute.	Al Matar, Imbaba , Giza	Giza Governorate	12511	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Prof. Dr. Sherin Hassan Mehani	Beni Suef Elgadata Street number 18	Beni Suef Governortae	62511	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Faculty of Physical Therapy Cairo University	In front Ben El-Sarayat Traffic Ad Doqi , Giza District	Giza Governorate	12511	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Sherin Mehani	drsherinm@gmail.com	+201003378217	Beni Suef Elgadata , Street number 18
City	Postal code	Country	Position/Affiliation
Beni Suef Governorate	62511	Egypt	Dean of Faculty of Physical Therapy Beni Suef University and Chairman of Physical Therapy Department for Cardiovascular Respiratory Disorders and Geriatrics
Role	Name	Email	Phone	Street address
Scientific Enquiries	Zeinab Helmy	Helmy.zeinab@gmail.com	+201114773311	Elminal, Elmakuas street
City	Postal code	Country	Position/Affiliation
Giza Governorate	12511	Egypt	Professor at Physical Therapy Department for Cardiovascular Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University
Role	Name	Email	Phone	Street address
Public Enquiries	Heba Ali	hebamali128@gmail.com	+201006327885	ElHarm street
City	Postal code	Country	Position/Affiliation
Giza Governorate	12511	Egypt	Lecturer at Physical Therapy Department for Cardiovascular Respiratory Disorders and Geriatrics Faculty of Physical Therapy Beni Suef University
Role	Name	Email	Phone	Street address
Public Enquiries	Moustafa Elnaggar	Helmy.zeinab@gmail.com	+201100364628	ElHarm street
City	Postal code	Country	Position/Affiliation
Giza Governorate	12511	Egypt	Lecturer at Physical Therapy Department for Internal Medicine Heliopolis University and National Heart Institute

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Individual participant data that underline the results reported in this article after deidentification ( text , tables, figures and appendices)	Clinical Study Report,Study Protocol	Within 12 months of the study completion date till 2 YEARS	Data could be accessed through the principal investigator through mail drsherinm@gmail.com for all physical therapists interested in cardiopulmonary rehabilitation
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
https://www.scopus.com/authid/detail.uri?authorId=55324341400	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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