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临床试验/NCT06870032
NCT06870032已完成不适用

The Impact of Pulmonary Rehabilitation on Respiratory Function and Quality of Life in Pediatric Patients With Chronic Lung Diseases: A Multidisciplinary Approach in Damietta Governorate

Horus University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Forced Expiratory Volume in One Second

研究概览

简要总结

Chronic lung diseases (CLDs) such as asthma, cystic fibrosis, and bronchopulmonary dysplasia significantly impact pediatric patients' respiratory function and overall well-being. Pulmonary rehabilitation (PR) has been shown to improve lung function, exercise tolerance, and quality of life in affected individuals. However, limited research has been conducted on PR implementation in Egypt.

详细描述

Pulmonary rehabilitation significantly enhances respiratory function, exercise capacity, and quality of life in pediatric patients with CLDs while reducing healthcare utilization. These findings highlight the necessity of integrating structured PR programs into pediatric respiratory care in Egypt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Diagnosed cases of CLDs, stable clinical condition, and ability to participate in rehabilitation.

排除标准

  • •Severe comorbidities, recent respiratory infections, or contraindications to physical activity.

研究组 & 干预措施

structured pulmonary rehabilitation

Other

The experimental group underwent a 12-week structured pulmonary rehabilitation program.

干预措施: structured pulmonary rehabilitation (Other)

standard medical care group

Active Comparator

Patients receiving standard medical care without structured pulmonary rehabilitation.

干预措施: standard medical care (Other)

结局指标

主要结局

Forced Expiratory Volume in One Second

时间窗: at basline and after 12-weeks of intervention

FEV₁ is the volume of air that a person can forcefully exhale in the first second of a forced breath after taking a deep inhalation. Interpretation of FEV₁: ≥80% of predicted → Normal 60-79% of predicted → Mild obstruction 40-59% of predicted → Moderate obstruction \<40% of predicted → Severe obstruction

Forced Vital Capacity

时间窗: at basline and after 12-weeks of intervention

FVC is the total volume of air that can be forcefully exhaled after taking the deepest possible breath. Normal Values: Typically ≥80% of the predicted value. Obstructive Lung Disease: FVC may be normal or slightly reduced. Restrictive Lung Disease: FVC is significantly reduced due to decreased lung compliance or lung volume.

Peak Expiratory Flow Rate

时间窗: at basline and after 12-weeks of intervention

PEFR is the maximum speed of expiration achieved after full lung inflation. It is measured in liters per minute (L/min). ormal values depend on age, sex, and height: Adult males: 450-700 L/min Adult females: 300-500 L/min Reduced PEFR: Suggests airway obstruction, such as in asthma or COPD.

次要结局

  • Hospitalization Frequency(at basline and after 12-weeks of intervention)
  • Medication Dependency(at basline and after 12-weeks of intervention)
  • Parental Satisfaction with Treatment(at basline and after 12-weeks of intervention)

研究者

发起方
Horus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Salah El-Sayed

Principal Investigator

Horus University

研究点 (1)

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