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

Official title

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

Overview

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

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

Interventions

• 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 {
• 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 + Exha
• 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
• 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

Primary outcome measures

• sternal instability [Time frame: at baseline and after finishing program (up to one month)]

Secondary outcome measures (3)

• 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)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• مستشفي القلب الحامعي -مستشفيات جامعه اسيوط — Asyut

Identifiers

NCT: NCT07381387 · FPTBSUREC/0102/131024 · NO secondary ID

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗