Exercise Training in Children With Corrective Cardiac Surgeries

Study Overview
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Brief Summary
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To determine the effects of preoperative exercise therapy on postoperative cardiopulmonary outcomes and quality of life in children with corrective cardiac surgeries.Within literature there is limited evidence on preoperative exercise therapy in the pediatric population, positive results of the study can introduce a new tradition of preoperative exercise therapy and significantly reduce post-operative complications. Secondary complications would also be addressed in the study, a positive result can reduce the total costs by reducing hospital stays and improving the quality of life of child.

Detailed Description
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Cardiac surgeries are often associated with some post-operative cardiopulmonary complications most often cardiac arrhythmias, pulmonary atelectasis, and hospital induced pneumonia and reduced inspiratory capacities which can be reduced by exercise therapy this study is therefore significant not only for the determination of the effects of preoperative exercise therapy, it will also provide a path toward pre-habilitation followed by effective postoperative cardiac rehabilitation which is mostly lacking in many setups.

Official Title
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Effects of Pre-operative Exercise Therapy on Postoperative Outcomes in Children With Corrective Cardiac Surgeries.

Conditions
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Quality of Life, Congenital Heart Disease, Heart; Surgery, Heart, Functional Disturbance as Result

Intervention / Treatment
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* Other: INTERVENTION GROUP
* Other: CONTROL GROUP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with congenital heart disease Undergoing elective corrective cardiac surgery Vitally stable Exclusion Criteria: Having acquired heart disease or undergoing emergency cardiac surgeries Patients undergoing valvular repairing surgeries Functional status is limited due to conditions other than CHD or having any contraindications Inability to adhere to study protocols Participants who refused or withdrew from the study

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>Preoperative Exercise therapy Patient Education, and post-operative conventional protocol. | Other: INTERVENTION GROUP<br>* Preoperative Protocol: DAY 1: Incentive spirometry 1 set of 2 repetitions(each repetition includes 05 deep inhalations) 3 times a day. Active ROMS (3 sets of 5 repetitions of both upper and lower limb thrice a day) Walk, Static marching to 10 steps thrice a day. DAY 2: Incentive spirometry 1 set of 3 repetitions (each repetition includes 08-10 deep inhalation) 3 times a day. Active ROMS, 3 sets of 5 repetitions of both upper and lower limb thrice a day) Walk, Static marching to 15 steps thrice a day. DAY 3: Incentive spirometry,1 set of 3 repetitions(each repetition includes 10 deep inhalation) 3 times a day Active ROMS 3 sets of 5 repetitions of both upper and lower limbs thrice a day. Walk, Static marching to 20 steps thrice a day. Postoperative Protocol: Conventional protocol of respective cardiac setup<br>|
| Active Comparator: Control group<br>Patient Education, and post-operative conventional protocol. | Other: CONTROL GROUP<br>* Preoperative: Patients' parents will be educated about the disease process, surgery, it's possible complications, and precautions. Postoperative: Conventional protocol of respective cardiac setup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of life | Changes from pre-operative to 15 days after discharge from the hospital, measured through a Pediatric quality of life questionnaire consisting of 23 questions that are categorized into 4 major components namely, Physical functioning (8 items), Emotional functioning (5 items), Social functioning (5 items), School functioning (5 items). The scoring of the scale is based on the frequency of performance of particular activity ranging from 0 (mean never performed) to 5(mean always functioning). | 4 weeks | 
| Post-operative Pulmonary complications | Changes from pre-operative to post-operative, discharge day and 15 days after discharge from the hospital, measured through chest x-ray including Consolidation, Atelectasis, Pneumonitis, Pleural Effusion. | 4 weeks | 
| Abnormal heart rhythms | pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor. | 7 days | 
| Forced Expiratory Volume in 1 second (FEV1) | Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters | 4 weeks | 
| Forced vital capacity | Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters. | 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary outcomes, Corrective cardiac surgeries, Preoperative Exercise therapy