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CompletedNCT06870032Updated Mar 11, 2025

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

An interventional study of standard medical care and structured pulmonary rehabilitation in Chronic Lung Disease, Quality of Life and Respiratory Function Impaired, sponsored by Horus University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Horus University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Nov 2022, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Chronic Lung Disease
  • Quality of Life
  • Respiratory Function Impaired
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 400 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Horus University is the lead sponsor of 31 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe comorbidities, recent respiratory infections, or contraindications to physical activity.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
400 participants (actual)

Study arms

  • Active comparator
    standard medical care group

    Patients receiving standard medical care without structured pulmonary rehabilitation.

    Other: standard medical care

  • Other
    structured pulmonary rehabilitation

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

    Other: structured pulmonary rehabilitation

Interventions

  • Otherstandard medical care

    standard medical care

  • Otherstructured 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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

07

Study locations

1 site
  • Out-patient Clinic, Faculty of Physical Therapy, Horus University
    Damietta, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06870032
Lead sponsor
Horus University
Responsible party
Mohamed Salah El-Sayed (Principal Investigator, Horus University) — Principal investigator
First posted
Mar 11, 2025
Start date
Nov 1, 2022
Primary completion
Nov 15, 2023
Completion
Dec 30, 2023
Last update
Mar 11, 2025

Study contacts

Mohamed El-Sayed
principal investigator · Horus University in Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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