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OpenTrials
Completed

NCT Number: NCT06870032

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

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Out-patient Clinic, Faculty of Physical Therapy, Horus University

Damietta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Standard Medical Care

Other

standard medical care

structured pulmonary rehabilitation

Other

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.

Primary outcomes

  1. Forced Expiratory Volume in One Second

    Time frame: 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

  2. Forced Vital Capacity

    Time frame: 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.

  3. Peak Expiratory Flow Rate

    Time frame: 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.

Secondary outcomes

  1. Hospitalization Frequency

    Time frame: at basline and after 12-weeks of intervention

    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.

  2. Medication Dependency

    Time frame: at basline and after 12-weeks of intervention

    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.

  3. Parental Satisfaction with Treatment

    Time frame: at basline and after 12-weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

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.

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