Skip to content

Exercise Training in Children With Corrective Cardiac Surgeries

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05763238
Enrollment
46
Registered
2023-03-10
Start date
2023-03-01
Completion date
2024-02-15
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cardiopulmonary outcomes, Corrective cardiac surgeries, Preoperative Exercise therapy

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.

Interventions

OTHERINTERVENTION 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

OTHERCONTROL 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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health related Quality of life4 weeksChanges 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).
Post-operative Pulmonary complications4 weeksChanges 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.
Abnormal heart rhythms7 dayspre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.
Forced Expiratory Volume in 1 second (FEV1)4 weeksChanges from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters
Forced vital capacity4 WeeksChanges from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026