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

Beni-Suef University

Status: Not yet enrolling

Conditions: Sternal Instability After Median Sternotomy

Treatments: 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: supra 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07381387

NO secondary ID (Other Identifier)

FPTBSUREC/0102/131024

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

Group A: Supra-abdominal + LLL

Experimental group

Description:

Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I

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

Group B: Infra-abdominal + LLL

Experimental group

Description:

Participants in this group receive a combined intervention in addition to the standard cardiac rehabilitation program during phase I.

Treatment:

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 group

Description:

Participants in this group receive low-level laser therapy in addition to the standard cardiac rehabilitation program during phase I.

Treatment:

Other: patients will receive Traditional cardiac rehabilitation program of phase one only

Group D: Control

Experimental group

Description:

Participants in this group receive the standard cardiac rehabilitation program during phase I.

Treatment:

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