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Starting soon Not applicable

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

NCT07381387 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-01-27
Last updated
2026-02-02

Condition(s) studied

Sternal Instability After Median Sternotomy

Investigational drug(s) / intervention(s)

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 LLLpatients will receive Traditional cardiac rehabilitation program of phase one only

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

): 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

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

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • sternal instability — 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.

Trial sites (1)

FacilityCityRegionStatus
مستشفي القلب الحامعي -مستشفيات جامعه اسيوط Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07381387 on ClinicalTrials.gov ↗ ← All trials in Egypt