Skip to main content
OpenTrials
Completed

NCT Number: NCT05763238

Exercise Training in Children With Corrective Cardiac Surgeries

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Quality of Life Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart; Surgery, Heart, Functional Disturbance as Result

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed forces institute of cardiology

Rawalpindi, Punjab Province, 4400, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Health related Quality of life

    Time frame: 4 weeks

    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).

  2. Post-operative Pulmonary complications

    Time frame: 4 weeks

    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.

  3. Abnormal heart rhythms

    Time frame: 7 days

    pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.

  4. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 4 weeks

    Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters

  5. Forced vital capacity

    Time frame: 4 Weeks

    Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.