Exercise Training in Children With Corrective Cardiac Surgeries

NCT ID: NCT05763238

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-02-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional Group

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

Group Type: EXPERIMENTAL

INTERVENTION GROUP

Intervention Type: 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

Control group

Patient Education, and post-operative conventional protocol.

Group Type: ACTIVE_COMPARATOR

CONTROL GROUP

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehwish Waseem, MSPT(CPPT)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Armed forces institute of cardiology

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 21059667 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23152283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20307858 (View on PubMed)

Other Identifiers

Rec/01386 Kanwal Zaheer

Identifier Type: -

Identifier Source: org_study_id