Sternal Instability After Median SternotomyLLL/CABGNCT07381387

Comparison of Supra-abdominal ex Versus Infra-abdominal With Laser on Median Sternotomy

A study testing supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one, ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one. and patients will receive Traditional cardiac rehabilitation program of phase one with LLL in people with Sternal Instability After Median Sternotomy, run by Beni-Suef University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sternal Instability After Median Sternotomy
What is being tested?: supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one, ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one. and patients will receive Traditional cardiac rehabilitation program of phase one with LLL
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteEgypt
Study dates: 27 Jan 2026to 27 Jul 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mayar Mohammed Khalifa Ahmed Ahmed, master contact

01091103744

mayarmora02@gmail.com

MAHMOUD IBRAHIM MOHAMED MOHAMED, lecture contact

+201142998414

Mahmoud.ibrahim@pt.bsu.edu.eg

Egypt1 site

مستشفي القلب الحامعي -مستشفيات جامعه اسيوط
Asyut
MOHAMMED AHMED KHALIL SALAMA SALAMA, professor, +201002001932, ayyadclinic@gmail.com

Other trials in Egypt

About this study

Official title: 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:

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

Read the 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

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

Conditions: Sternal Instability After Median Sternotomy
Being tested: supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one, ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one., patients will receive Traditional cardiac rehabilitation program of phase one with LLL, patients will receive Traditional cardiac rehabilitation program of phase one only
Keywords: sternal instability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase oneBehavioural
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
): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one.Behavioural
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
patients will receive Traditional cardiac rehabilitation program of phase one with LLLBehavioural
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
patients will receive Traditional cardiac rehabilitation program of phase one onlyOther
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

Study groups in NCT07381387
Study group	Role	What they receive
Group A: Supra-abdominal + LLL	Experimental	Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I Receives: 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
Group B: Infra-abdominal + LLL	Experimental	Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I. Receives: Behavioral: ): patients will infra 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
Group C: LLL Only	Experimental	Participants in this group receive low-level laser therapy in addition to the standard cardiac rehabilitation program during phase I. Receives: Other: patients will receive Traditional cardiac rehabilitation program of phase one only
Group D: Control	Experimental	Participants in this group receive the standard cardiac rehabilitation program during phase I. Receives: Behavioral: patients will receive Traditional cardiac rehabilitation program of phase one with LLL; Other: patients will receive Traditional cardiac rehabilitation program of phase one only

What is being measured

The primary outcome is the main question the study is designed to answer.

sternal instability
1. 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
2. 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.
Measured: at baseline and after finishing program (up to one month)

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: at baseline and after finishing program (up to one month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 202627 Jul 2026

First posted2 Feb 2026
Study start27 Jan 2026 (estimated)
Primary completion27 Jul 2026 (estimated)
Study completion27 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sternal Instability After Median SternotomyStudies of the same condition, open and under way.
More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07381387
Sponsor's protocol ID: FPTBSUREC/0102/131024
Other IDs: NO secondary ID
Acronym: LLL/CABG
Status last verified: Jan 2026
First submitted: 27 Nov 2025
Last updated: 2 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Supra-abdominal Versus Infra-abdominal Muscles Training Combined With LASER on Sternal Instability After Open Heart Surgery
ClinicalTrials.gov ID: NCT07381387
Acronym / sponsor ID: LLL/CABG / FPTBSUREC/0102/131024
Conditions: Sternal Instability After Median Sternotomy
Keywords: sternal instability
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Beni-Suef UniversityUniversity, hospital or other
Study start: 27 Jan 2026 (estimated)
Primary completion: 27 Jul 2026 (estimated)
Study completion: 27 Jul 2026 (estimated)
First posted: 2 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group A: Supra-abdominal + LLL	Experimental	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 onlyParticipants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I
Group B: Infra-abdominal + LLL	Experimental	Behavioral: ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one., Other: patients will receive Traditional cardiac rehabilitation program of phase one onlyParticipants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I.
Group C: LLL Only	Experimental	Other: patients will receive Traditional cardiac rehabilitation program of phase one onlyParticipants in this group receive low-level laser therapy in addition to the standard cardiac rehabilitation program during phase I.
Group D: Control	Experimental	Behavioral: patients will receive Traditional cardiac rehabilitation program of phase one with LLL, Other: patients will receive Traditional cardiac rehabilitation program of phase one onlyParticipants in this group receive the standard cardiac rehabilitation program during phase I.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase oneEx 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	Behavioural	Group A: Supra-abdominal + LLL
): 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	Behavioural	Group B: Infra-abdominal + LLL
patients will receive Traditional cardiac rehabilitation program of phase one with LLLA 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	Behavioural	Group D: Control
patients will receive Traditional cardiac rehabilitation program of phase one onlyPatients 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	Other	Group A: Supra-abdominal + LLL, Group B: Infra-abdominal + LLL, Group C: LLL Only, Group D: Control

Primary outcome

sternal instability
Time frame: at baseline and after finishing program (up to one month)
1. 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 2. 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.

3 secondary outcomes

Functional Impairment Scale:
Time frame: at baseline and after finishing program (up to one month)
pain assessment
Time frame: at baseline and after finishing program (up to one month)
The Activity Status Index for Duke
Time frame: at baseline and after finishing program (up to one month)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Mayar Mohammed Khalifa Ahmed Ahmed, master contact

01091103744

mayarmora02@gmail.com

MAHMOUD IBRAHIM MOHAMED MOHAMED, lecture contact

+201142998414

Mahmoud.ibrahim@pt.bsu.edu.eg

SHERIN HASSAN MOHAMMED MEHANI. MEHANI., professor principal investigator

benisueif university

MOHAMMED AHMED KHALIL SALAMA SALAMA, professor principal investigator

Assiut University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mayar Mohammed Khalifa Ahmed Ahmed, master (01091103744, mayarmora02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sternal instability (time frame: at baseline and after finishing program (up to one month)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.