Clinical trial NCT05763238: Exercise Training in Children With Corrective Cardiac Surgeries
Official title: Effects of Pre-operative Exercise Therapy on Postoperative Outcomes in Children With Corrective Cardiac Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Congenital Heart Disease
Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: Cardiopulmonary outcomes
Corrective cardiac surgeries
Preoperative Exercise therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health related Quality of life
timeFrame: 4 weeks
measure: Post-operative Pulmonary complications
timeFrame: 4 weeks
measure: Abnormal heart rhythms
timeFrame: 7 days
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 4 weeks
measure: Forced vital capacity
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed forces institute of cardiology
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valkenet K, van de Port IG, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011 Feb;25(2):99-111. doi: 10.1177/0269215510380830. Epub 2010 Nov 8.
citation: Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD010118. doi: 10.1002/14651858.CD010118.pub2.
citation: Bernier PL, Stefanescu A, Samoukovic G, Tchervenkov CI. The challenge of congenital heart disease worldwide: epidemiologic and demographic facts. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):26-34. doi: 10.1053/j.pcsu.2010.02.005.