Pulmonary Rehabilitation and Quality of Life in Children With Chronic Lung Diseases: A Multidisciplinary Approach

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Chronic Lung Disease; Respiratory Function Impaired
• Intervention / Treatment: Other: standard medical care; Other: structured pulmonary rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt
    • out-patient clinic, faculty of physical therapy, Horus university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard medical care group; Patients receiving standard medical care without structured pulmonary rehabilitation.	Other: standard medical care; standard medical care
Other: structured pulmonary rehabilitation; The experimental group underwent a 12-week structured pulmonary rehabilitation program.	Other: structured pulmonary rehabilitation; structured pulmonary rehabilitation program including: Physical Therapy: Breathing exercises, airway clearance techniques, inspiratory muscle training.; Pediatrics & Chest Medicine: Medical supervision, optimization of pharmacological treatment.; Physiology: Monitoring pulmonary function and physiological responses to exercise.; Public Health: Evaluating program feasibility and its impact on healthcare utilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in One Second	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	at basline and after 12-weeks of intervention
Forced Vital Capacity	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.	at basline and after 12-weeks of intervention
Peak Expiratory Flow Rate	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.	at basline and after 12-weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization Frequency	Hospitalization frequency refers to the number of times a patient is admitted to a hospital due to disease exacerbation, complications, or treatment failure. Number of hospital admissions within a specific time frame (e.g., per year). Length of hospital stay (days per admission). Emergency department visits requiring inpatient care.	at basline and after 12-weeks of intervention
Medication Dependency	Medication dependency refers to the extent to which a patient relies on pharmacological treatment to manage symptoms and maintain functional health. Frequency and dosage of medication use. Number of rescue medication uses (e.g., bronchodilators in asthma). Reduction or discontinuation of medication over time.	at basline and after 12-weeks of intervention
Parental Satisfaction with Treatment	Parental satisfaction refers to how parents perceive the effectiveness, convenience, and overall impact of their child's treatment plan. Standardized satisfaction surveys (e.g., Likert scale questionnaires). Interviews or focus groups with parents. Feedback on treatment effectiveness, side effects, accessibility, and ease of use.	at basline and after 12-weeks of intervention

Collaborators and Investigators

• Sponsor: Horus University
• Investigators: Principal Investigator: Mohamed El-Sayed, Horus University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency
• Other Study ID Numbers: PostDoc_012025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No