Exercise Training in Children With Corrective Cardiac Surgeries

Not Applicable

Completed

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

• Registration Number: NCT05763238
• Lead Sponsor: Riphah International University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study Start: 2023-03-01
• Study First Posted: 2023-03-10
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health related Quality of life	4 weeks	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).
Abnormal heart rhythms	7 days	pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.
Post-operative Pulmonary complications	4 weeks	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.
Forced Expiratory Volume in 1 second (FEV1)	4 weeks	Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters
Forced vital capacity	4 Weeks	Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters.

Trial Locations

Locations (1)

Armed forces institute of cardiology; 🇵🇰 Rawalpindi, Punjab, Pakistan