Chronic Lung DiseaseNCT06870032
Pulmonary Rehabilitation and Quality of Life in Children With Chronic Lung Diseases: A Multidisciplinary Approach
A study testing standard medical care and structured pulmonary rehabilitation in people with Chronic Lung Disease and Quality of Life, run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lung Disease, Quality of Life, Respiratory Function Impaired
- What is being tested?
- standard medical care and structured pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed cases of CLDs, stable clinical condition, and ability to participate in rehabilitation.
Who cannot join
- Severe comorbidities, recent respiratory infections, or contraindications to physical activity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out-patient Clinic, Faculty of Physical Therapy, Horus University
Damietta
About this study
Official 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
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.
- Being tested
- standard medical care, structured pulmonary rehabilitation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard medical careOther
standard medical care
structured pulmonary rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| standard medical care group | Active comparator | Patients receiving standard medical care without structured pulmonary rehabilitation. Receives: Other: standard medical care |
| structured pulmonary rehabilitation | Other | The experimental group underwent a 12-week structured pulmonary rehabilitation program. Receives: Other: structured pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: at basline and after 12-weeks of intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at basline and after 12-weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Nov 2022
- Primary completion15 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El-Sayed, Horus University
- Investigators
- Mohamed El-Sayed, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870032
- Sponsor's protocol ID
- PostDoc_012025
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06870032
- Acronym / sponsor ID
- PostDoc_012025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard medical care group | Active comparator | Other: standard medical carePatients receiving standard medical care without structured pulmonary rehabilitation. |
| structured pulmonary rehabilitation | Other | Other: structured pulmonary rehabilitationThe experimental group underwent a 12-week structured pulmonary rehabilitation program. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosed cases of CLDs, stable clinical condition, and ability to participate in rehabilitation.
Key exclusion criteria (1 listed)
- Severe comorbidities, recent respiratory infections, or contraindications to physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard medical carestandard medical care | Other | standard medical care group |
| structured pulmonary rehabilitationstructured 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. | Other | structured pulmonary rehabilitation |
Primary outcome
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
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.
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.
3 secondary outcomes
Hospitalization Frequency
Time frame: at basline and after 12-weeks of intervention
Medication Dependency
Time frame: at basline and after 12-weeks of intervention
Parental Satisfaction with Treatment
Time frame: at basline and after 12-weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed El-Sayed principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard medical care and structured pulmonary rehabilitation in people with Chronic Lung Disease and Quality of Life, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in One Second (time frame: at basline and after 12-weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.