Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU

Study Overview
=================
Brief Summary
-----------------
To determine the effect of limb ROMs along with chest Physical therapy on cardiopulmonary parameters after correction of congenital heart diseases in ICU To determine the response of Inotropic drug in relation to Limb ROMs after Correction of Congenital heart diseases in ICU

Official Title
-----------------
Effect of Limbs Range of Motion Exercises Along With Chest Physical Therapy on Cardiopulmonary Parameters After Correction of Congenital Heart Diseases in ICU

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Conventional treatment
* Other: Limb Range of Motion Exercises + Chest Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients below the age 5 years old that underwent congenital heart surgery. Exclusion Criteria: Contraindications for exercise, mental retardation, unstable hemodynamics

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>Chest Physical Therapy | Other: Conventional treatment<br>* Chest Physical Therapy as required<br>|
| Experimental: Limb Range of Motion Exercises + Chest Physical Therapy<br>Limb Range of Motion Exercises + Chest Physical Therapy | Other: Limb Range of Motion Exercises + Chest Physical Therapy<br>* Limb Range of Motion Exercises + Chest Physical Therapy Frequency: 4 sessions Time: 5 to 10 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Changes from baseline, Heart rate was measured per minute through cardiac monitor | Upto 10 days | 
| Respiration Rate | Changes from baseline,respiratory rate was measured per minute through cardiac monitor | Upto 10 days | 
| Systolic Blood Pressure | Changes from the Baseline, Blood pressure is measured through sphygmomanometer | Upto 10 days | 
| Diastolic Blood Pressure | Changes from the Baseline, Blood pressure is measured through sphygmomanometer | Upto 10 days | 
| Partial pressure of oxygen | Changes from the Baseline, Blood pressure is measured through sphygmomanometer | Upto 10 days | 
| Partial Pressure of carbon dioxide | Changes from the Baseline, Blood pressure is measured through sphygmomanometer | Upto 10 days | 
| Arterial blood gas (ABG) parameter like potential of hydrogen (PH) | Above parameter was measured by serial ABG analysis. Its normal reference range is 7.35-7.45. baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline | Upto 10 days | 
| Arterial blood gas parameter like bicarbonate(HCO3). | Above parameter was measured by serial ABG analysis. Its normal reference range is 22-28 nmol/L. Baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline | Upto 10 days | 
| Oxygen saturation | Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it. | Upto 10 days | 
| Ejection fraction | Change from baseline Ejection fraction through Echocardiography | Upto 10 days |