跳至主要内容
临床试验/NCT05763238
NCT05763238已完成不适用

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

Riphah International University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Health related Quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Health related Quality of life

时间窗: 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).

Abnormal heart rhythms

时间窗: 7 days

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

Post-operative Pulmonary complications

时间窗: 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.

Forced Expiratory Volume in 1 second (FEV1)

时间窗: 4 weeks

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

Forced vital capacity

时间窗: 4 Weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Exercise Training in Children With Corrective... | 临床试验