Exercise Training in Children With Corrective Cardiac Surgeries

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763238
• Other study ID #: Rec/01386 Kanwal Zaheer
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 15, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart; Surgery, Heart, Functional Disturbance as Result
• Quality of Life

Intervention

Other:
• INTERVENTION GROUP
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
• CONTROL GROUP
Preoperative: Patients' parents will be educated about the disease process, surgery, it's possible complications, and precautions. Postoperative: Conventional protocol of respective cardiac setup

Locations

Country	Name	City	State
Pakistan	Armed forces institute of cardiology	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Abnormal heart rhythms	pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.	7 days
Primary	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
Primary	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