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

NCT06870032 | Completed DMC

• 1 other identifier: PostDoc_012025
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lung Disease; Quality of Life; Respiratory Function Impaired

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

standard medical care group

ACTIVE COMPARATOR

Patients receiving standard medical care without structured pulmonary rehabilitation.

Other: standard medical care

structured pulmonary rehabilitation

OTHER

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

Other: structured pulmonary rehabilitation

Interventions

standard medical care OTHER

standard medical care

standard medical care group

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.

structured pulmonary rehabilitation

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

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

Damietta, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mohamed El-Sayed

  Horus University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: November 1, 2022
• Primary Completion: November 15, 2023
• Study Completion: December 30, 2023
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

EG (1)