Comparison of Supra-abdominal ex Versus Infra-abdominal With Laser on Median Sternotomy (LLL/CABG)

Effect of Supra-abdominal Versus Infra-abdominal Muscles Training Combined With LASER on Sternal Instability After Open Heart Surgery

the aim of this study is to find out the differences between the effect of supra- abdomen exercises and the effect of infra-abdomen exercise combined with LASER And the effect of LOW LEVEL LASER only on sternal instability. Methods: 120 patients of both sexes who had acute sternal instability post-open heart surgery will be recruited in this study at Assiout University Hospitals; their ages will be > 18 years. They will be randomly assigned into 4 equal groups:

1. Study group (A): patients will receive supra-abdominal resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
2. Study group (B): patients will do infra-abdominal resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
3. Study group (c): patients will receive a traditional cardiac rehabilitation pro-gram of phase one with LLL
4. Control group: patients will receive the traditional cardiac rehabilitation pro-gram of phase one only

Study Overview

• Status: Not yet recruiting
• Conditions: Sternal Instability After Median Sternotomy
• Intervention / Treatment: Behavioral: supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one; Other: patients will receive Traditional cardiac rehabilitation program of phase one only; Behavioral: ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one.; Behavioral: patients will receive Traditional cardiac rehabilitation program of phase one with LLL

Detailed Description

Type of study: Randomized controlled trial This study is a prospective interventional study one that will be conducted on 120 patients of both sexes who had acute sternal instability post-open heart surgery; their ages will be < 18 years. They will be recruited from Assiut University Hospitals and will randomly be divided into 4 equal groups

1. Study group (A): patients will receive supra-abdomen resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
2. Study group (B): patients will do infra-abdomen resisted exercises combined with LLL and the traditional cardiac rehabilitation program of phase one.
3. Study group (c): patients will receive a traditional cardiac rehabilitation pro-gram of phase one with LLL
4. Control group: patients will receive Traditional cardiac rehabilitation pro-gram of phase one only

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mayar Mohammed Khalifa Ahmed Ahmed, master; Phone Number: 01091103744; Email: mayarmora02@gmail.com
• Study Contact Backup: Name: MAHMOUD IBRAHIM MOHAMED MOHAMED, lecture; Phone Number: +201142998414; Email: Mahmoud.ibrahim@pt.bsu.edu.eg

Study Locations

• Egypt
  • Asyut, Egypt
    • مستشفي القلب الحامعي -مستشفيات جامعه اسيوط
    • Contact: MOHAMMED AHMED KHALIL SALAMA SALAMA, professor; Phone Number: +201002001932; Email: ayyadclinic@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

IInclusion criteria :

All included patients will be:

• Their age 18<.
• Both sexes.
• Hemodynamic stable.
• Acute sternal instability.
• Able to provide informed consent.

Exclusion criteria:

Patient will be excluded if:

• Emergency or urgent operation.
• Revision sternotomy.
• Manifesting hypoxemia.
• Partial oxygen pressure in arterial blood < 60 mmHg.
• Renal insufficiency with serum creatinine ≥ 1. 8 mg/dl after surgery.
• Low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads.
• Cardiac arrhythmias or hypotension.
• Other medical conditions, such as diabetes, uncontrolled hypertension and obesity.
• Previous medical history including conditions that may have influenced the provision of physiotherapy interventions, such as severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse.
• Impaired cognition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Supra-abdominal + LLL; Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I	Behavioral: supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one; Ex 1:- Sitting In Erect Position + Breathing For 3 Min And Repeat 2 Times {Neutral Spine } Ex 2:- Hands On Lower Costal + Inhale Maximally For 5 Sec, Exhale Slowly With Abdominal Muscle Contract And Repeat 10 Times {Thoracic Expansion } Ex 3 :- Hands On Iliac Crest Deep Inhalation + Slow Exhalation For 5 Sec + Contraction Of Abdominal Muscle With Hands Closing At The Hip {Abdominal } Ex 4 :- Inhale Rotate The Trunk To Opposite Side Of Resistance Given By PT + Exhale + Contract Abdominal Muscle { Abdominal Ex With Trunk Rotation } Ex 5:- Cross Arm On Upper Thorax Inhale Raising + Exhale + Contract + While Expiration, Incline Trunk To Opposite Of Resistance Repeat 5 Times For Each Arm Separately Ex6:- Inhale + Raising Two Arm To Shoulder Level With Extended Elbow + Exhale + Contract 5 Sec {Arm - Trunk Dissociation } Repeat 10 Times Ex 7:- Inhale + Flex Arm With Extension Elbow + Exhale + Contract And Return Arm {Alternate Trunk And Shoulder Dissociatio; Other: patients will receive Traditional cardiac rehabilitation program of phase one only; Patients will be instructed to perform deep breathing using incentive spirometry in the form of four sets, each consisting of 10 deep breaths for a total of 40 deep breaths, with a hold at the end of inspiration, then huffs and coughs with the support of pillows at the incision. The patients will be instructed to follow sternal precautions
Experimental: Group B: Infra-abdominal + LLL; Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I.	Other: patients will receive Traditional cardiac rehabilitation program of phase one only; Patients will be instructed to perform deep breathing using incentive spirometry in the form of four sets, each consisting of 10 deep breaths for a total of 40 deep breaths, with a hold at the end of inspiration, then huffs and coughs with the support of pillows at the incision. The patients will be instructed to follow sternal precautions; Behavioral: ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one.; Ex 1:- Sitting In Erect Position + Breathing For 3 MinAnd Repeat 2 Times Ex 2:- Hands On Lower Costal + Inhale Maximally For 5 Sec, Exhale Slowly With Abdominal Muscle Contract And Repeat 10 Times Ex 3 :- Hands On Iliac Crest Deep Inhalation + Slow Exhalation For 5 Sec + Contraction Of Abdominal Muscle With Hands Closing At The Hip Ex 4 :- Inhale Rotate The Trunk To Opposite Side Of Resistance Given By PT + Exhale + Contract Abdominal Muscle Ex 5:- Cross Arm On Upper Thorax Inhale Raising + Exhale + Contract + While Expiration, Incline Trunk To Opposite Of Resistance Repeat 5 Times For Each Arm Separately Ex 6 :- Inhale + Raise Knee With Flexed Hip + Expiration + Contract Ex 7: Inhale + Exhale + Adducting Hip And Knees + Contract Ex 8 :- Inhale + Raise One Knee + Exhale+Contract+Trunk Rotation To The Side Of Raised Leg
Experimental: Group C: LLL Only; Participants in this group receive low-level laser therapy in addition to the standard cardiac rehabilitation program during phase I.	Other: patients will receive Traditional cardiac rehabilitation program of phase one only; Patients will be instructed to perform deep breathing using incentive spirometry in the form of four sets, each consisting of 10 deep breaths for a total of 40 deep breaths, with a hold at the end of inspiration, then huffs and coughs with the support of pillows at the incision. The patients will be instructed to follow sternal precautions
Experimental: Group D: Control; Participants in this group receive the standard cardiac rehabilitation program during phase I.	Other: patients will receive Traditional cardiac rehabilitation program of phase one only; Patients will be instructed to perform deep breathing using incentive spirometry in the form of four sets, each consisting of 10 deep breaths for a total of 40 deep breaths, with a hold at the end of inspiration, then huffs and coughs with the support of pillows at the incision. The patients will be instructed to follow sternal precautions; Behavioral: patients will receive Traditional cardiac rehabilitation program of phase one with LLL; A probe laser device will be usedat median sternotomy site. at a distance of 2 cm from each other, for a total of five to eight points. the device will be placed in a perpendicular position to the sternum each spot for 60 sec for a total session time of 5-10 min. Each patient will receive one session daily, three times a week, for four consecutive weeks:•Treatment time per point (s) 60•Laser beam Class :3B•Laser Type :Semiconductor GaA.Modes of Operation :Continuous Pulse upto 5 khz.•Wave Length: 685nm•Maximum Probe Power: 500 mw•Power Density:0.8w/cm2•Max Energy within 1 min 2.4 Joules•Number of spots 8 Patients will be instructed to perform deep breathing using incentive spirometry in the form of four sets, each consisting of 10 deep breaths for a total of 40 deep breaths, with a hold at the end of inspiration, then huffs and coughs with the support of pillows at the incision. The patients will be instructed to follow sternal precautions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sternal instability	Sternal separation measurement: The ultrasound unit head was adapted by fixing it to a microphone stand to facilitate contact with the chest of a seated subject. The amount of sternal separation at different vertical points on the sternum could now be measured from the projected image using the proprietary software for the unit; Sternal instability scale:Grade 0:Clinically stable sternum, no detectable motion (normal).Grade 1:Minimally separated sternum with a slight increase in motion upon special testing (upper limbs, trunk).Grade 2:Partially separated sternum, regional with moderate increase in motion upon special testing.Grade 3:Completely separated sternum along the entire length with marked increase in motion upon special testing.	at baseline and after finishing program (up to one month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Impairment Scale:	1)Functional Impairment Scale: Functional impairment was based on a numerical scale from 0 to 10, as follows: 0-3, did not interfere with activities; 4-6, interfered but did not prevent activities; 7-9, prevented activities; and 10, prevented activities and/or caused lack of control Higher scores indicate greater functional impairment.	at baseline and after finishing program (up to one month)
pain assessment	Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Participants will be asked to mark the point that best reflects their perceived pain intensity. Higher scores indicate greater pain intensity.	at baseline and after finishing program (up to one month)
The Activity Status Index for Duke	Functional capacity will be assessed using the Duke Activity Status Index (DASI), a self-reported 12-item questionnaire that evaluates the ability to perform daily physical activities and estimates functional capacity in metabolic equivalents (METs). Scores range from 0 to 58.2, with higher scores indicating better functional capacity.	at baseline and after finishing program (up to one month)

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: SHERIN HASSAN MOHAMMED MEHANI. MEHANI., professor, benisueif university; Principal Investigator: MOHAMMED AHMED KHALIL SALAMA SALAMA, professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 27, 2026
• Primary Completion (Estimated): July 27, 2026
• Study Completion (Estimated): July 27, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: sternal instability
• Other Study ID Numbers: FPTBSUREC/0102/131024; No secondary ID (Other Identifier: Istinye University Human Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No