Exercise Training in Children With Corrective Cardiac Surgeries

NCT05763238 | Completed DMC

• 1 other identifier: Rec/01386 Kanwal Zaheer
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiopulmonary outcomes; Corrective cardiac surgeries; Preoperative Exercise therapy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Interventional Group

EXPERIMENTAL

Preoperative Exercise therapy Patient Education, and post-operative conventional protocol.

Other: INTERVENTION GROUP

Control group

ACTIVE COMPARATOR

Patient Education, and post-operative conventional protocol.

Other: CONTROL GROUP

Interventions

INTERVENTION GROUP OTHER

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

Interventional Group

CONTROL GROUP OTHER

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

Control group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with congenital heart disease
• Undergoing elective corrective cardiac surgery
• Vitally stable

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Armed forces institute of cardiology

Rawalpindi, Punjab Province, 4400, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 21059667 BACKGROUND

• 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.

  PMID: 23152283 BACKGROUND

• 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.

  PMID: 20307858 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mehwish Waseem, MSPT(CPPT)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: March 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 15, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)