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NCT Number: NCT07381387

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

مستشفي القلب الحامعي -مستشفيات جامعه اسيوط

Asyut, Egypt

Location contact

MOHAMMED AHMED KHALIL SALAMA SALAMA, professor

CONTACT

[email protected]

+201002001932

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one

Behavioral

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.

Behavioral

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

Behavioral

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

Other

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

Primary outcomes

  1. sternal instability

    Time frame: at baseline and after finishing program (up to one month)

    • 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.

Secondary outcomes

  1. Functional Impairment Scale:

    Time frame: at baseline and after finishing program (up to one month)

    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.

  2. pain assessment

    Time frame: at baseline and after finishing program (up to one month)

    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.

  3. The Activity Status Index for Duke

    Time frame: at baseline and after finishing program (up to one month)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

MAHMOUD IBRAHIM MOHAMED MOHAMED, lecture

CONTACT

[email protected]

+201142998414

Mayar Mohammed Khalifa Ahmed Ahmed, master

CONTACT

[email protected]

01091103744

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: LLL/CABG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.