Interstitial Lung DiseaseNCT06991153
Impact of Lung Boost Device on Ventilatory Functions and Fatigue in Patients With Interstitial Lung Diseases
A study testing Lung Boost Device Training, Traditional physical therapy program and Medical Treatment in people with Interstitial Lung Disease, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study will be to determine the effect of lung boost exercise on ventilatory functions, fatigue, and physical function capacity in Interstitial lung disease patients. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Lung Boost Device Training, Traditional physical therapy program and Medical Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2025to 7 Aug 2025
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Forty female patients have Interstitial lung disease .
- All patients diagnosed as ILD on clinical and radiological basis.
- Age will range between 45 to 55 years old .
- All patients will be with mild hypoxemia range from 90 to 92 oxygen saturation
- They have Interstitial lung disease for at least 3 years ago.
- Stable in medical and hemodynamic state
Who cannot join
- Cardiovascular (as acute heart failure, unstable angina or recent myocardial infarction)
- Patients with other significant respiratory disorders such as acute infections, pulmonary tuberculosis, chronic obstructive pulmonary disease, asthma, bronchiectasis, lung carcinoma, and pneumothorax.
- cognitive impairments, history of cerebrovascular accident, active cancer will be excluded.
- Hepatitis, cirrhosis.
- Current treatment for cancer or active infection
- Orthopedic problem.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will be to determine the effect of lung boost exercise on ventilatory functions, fatigue, and physical function capacity in Interstitial lung disease patients.
Read the detailed description
Death rates from chronic respiratory diseases have recently increased, largely driven by the rising burden of interstitial lung diseases (ILDs) doubling mortality rates over the past 4 decades. Pulmonary fibrosis (PF), a form of ILD, is characterized by destruction of lung tissue and accounts for the highest increase in mortality rates.
According to the Global Burden of Disease Study, between the years of 1990 and 2013, there was an 86% increase in ILD related years of life lost, and, for the first time, among the top 50 causes of global years of life lost.
In patients with ILD next to dyspnea, fatigue is expected to be the most prevalent symptom. Surprisingly, the prevalence of severe fatigue has been scarcely studied in ILD patients and limited information on its associated factors is available.
ILDs are associated with skeletal muscle dysfunction, worsening exercise capacity, and poor health-related quality of life.
So,This study will explore the impact of lung boost on ventilatory function, fatigue and physical function capacity in interstitial lung disease patients and may give a suggestion of therapeutic modality that is easy and applicable groups of patients to decrease the symptoms and improve the quality of life for this patients.
- Conditions
- Interstitial Lung Disease
- Being tested
- Lung Boost Device Training, Traditional physical therapy program, Medical Treatment
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Boost Device TrainingDevice
Patients in the experimental group will train with the Lung Boost Respiratory Trainer (MD800) for 8 weeks, three times weekly, totaling 24 sessions. The procedure will be explained, and equipment sanitized before use. Training begins in strength mode at level 1, where patients inhale deeply through a mouthpiece, with feedback provided via on-screen balls. If level 5 is easily reached, resistance increases using a cone, restarting at level 1. Sessions include 15 repetitions of 2-3 second inhalations and exhalations, performed in three sets with 15-second rests to prevent fatigue. In endurance mode, patients inhale or exhale as long as possible, progressing gradually from level 1. Each session lasts 15 minutes, divided into three sets of five breaths with 15-second rests. This structured program enhances respiratory muscle strength and endurance.
Traditional physical therapy programOther
Patients in both groups will receive a traditional physical therapy program for the chest in form of diaphragmatic breathing exercise and pursed-lip breathing exercise for 8 weeks.
Medical TreatmentDrug
Also called corticosteroids
Patients in both groups will receive medical treatment for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lung Boost Device Training + Traditional physical therapy program + Medical Treatment | Experimental | Twenty patients will receive respiratory training using lung boost 3 sessions per week for 8 weeks plus maintain their medical treatment. Receives: Device: Lung Boost Device Training; Other: Traditional physical therapy program; Drug: Medical Treatment |
| Traditional physical therapy program + Medical Treatment | Active comparator | Twenty patient will receive traditional physical therapy program in addition to medical treatment. Receives: Other: Traditional physical therapy program; Drug: Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
It will be assessed for all participants before and after treatment, using an electronic spirometer .
Measured: 8 weeks
The first second of forced expiration (FEV1)
It will be assessed for all participants before and after treatment, using an electronic spirometer .
Measured: 8 weeks
FEV1/FVC ratio
It will be assessed for all participants before and after treatment, using an electronic spirometer .
Measured: 8 weeks
Fatigue Severity Scale (FSS)
It will be used to measure fatigue severity for all participants before and after treatment. The FSS is one of the most frequently used inventories for measuring fatigue in people with chronic illnesses. The original FSS is a nine-item questionnaire developed to measure fatigue severity as a unidimensional concept. Each FSS item consists of statements that are scored on a seven-point Likert type scale, ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Measured: 8 weeks
Secondary outcomes (3)
oxygen saturation (SpO2)
It will be assessed for all participants before and after treatment, using a pulse oximetry, which is a simple, non-invasive, widely available medical tool that measures oxygen saturation (SpO2) through a device attached to a finger, a toe or an earlobe.
Measured: 8 weeks
6-min walk test (6MWT)
It will be used to assess functional exercise capacity for all participants before and after treatment. The 6MWT is a validated tool, of submaximal intensity, Used to objectively measure functional exercise capacity. Individual walks without assistance for 6 minutes and the distance is measured.
Measured: 8 weeks
King's Brief Interstitial Lung Disease (K-BILD) questionnaire
It will be used to assess health impairments induced by ILD for all participants before and after treatment. The questionnaire covers 15 questions spread out in three domains ("breathlessness and activity", "chest symptoms" and "psychological impact") via a seven point Likert Scale. The total (cross-domain) score and domain-specific subscores range from zero to 100 with higher values indicating better health.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2025
- Study start29 May 2025
- Primary completion29 Jul 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mokhtar Mahmoud Mohamed, Cairo University
- Investigators
- Nesreen Gharib El Nahas, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991153
- Sponsor's protocol ID
- P.T.REC/012/005083
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lung Boost Device on Ventilatory Functions and Fatigue in Patients With Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT06991153
- Acronym / sponsor ID
- P.T.REC/012/005083
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 26 May 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.
The purpose of this study will be to determine the effect of lung boost exercise on ventilatory functions, fatigue, and physical function capacity in Interstitial lung disease patients.
Detailed description
Death rates from chronic respiratory diseases have recently increased, largely driven by the rising burden of interstitial lung diseases (ILDs) doubling mortality rates over the past 4 decades. Pulmonary fibrosis (PF), a form of ILD, is characterized by destruction of lung tissue and accounts for the highest increase in mortality rates.
According to the Global Burden of Disease Study, between the years of 1990 and 2013, there was an 86% increase in ILD related years of life lost, and, for the first time, among the top 50 causes of global years of life lost.
In patients with ILD next to dyspnea, fatigue is expected to be the most prevalent symptom. Surprisingly, the prevalence of severe fatigue has been scarcely studied in ILD patients and limited information on its associated factors is available.
ILDs are associated with skeletal muscle dysfunction, worsening exercise capacity, and poor health-related quality of life.
So,This study will explore the impact of lung boost on ventilatory function, fatigue and physical function capacity in interstitial lung disease patients and may give a suggestion of therapeutic modality that is easy and applicable groups of patients to decrease the symptoms and improve the quality of life for this patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Boost Device Training + Traditional physical therapy program + Medical Treatment | Experimental | Device: Lung Boost Device Training, Other: Traditional physical therapy program, Drug: Medical TreatmentTwenty patients will receive respiratory training using lung boost 3 sessions per week for 8 weeks plus maintain their medical treatment. |
| Traditional physical therapy program + Medical Treatment | Active comparator | Other: Traditional physical therapy program, Drug: Medical TreatmentTwenty patient will receive traditional physical therapy program in addition to medical treatment. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Forty female patients have Interstitial lung disease .
- All patients diagnosed as ILD on clinical and radiological basis.
- Age will range between 45 to 55 years old .
- All patients will be with mild hypoxemia range from 90 to 92 oxygen saturation
- They have Interstitial lung disease for at least 3 years ago.
Key exclusion criteria (6 listed)
- Cardiovascular (as acute heart failure, unstable angina or recent myocardial infarction)
- Patients with other significant respiratory disorders such as acute infections, pulmonary tuberculosis, chronic obstructive pulmonary disease, asthma, bronchiectasis, lung carcinoma, and pneumothorax.
- cognitive impairments, history of cerebrovascular accident, active cancer will be excluded.
- Hepatitis, cirrhosis.
- Current treatment for cancer or active infection
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 |
|---|---|---|
| Lung Boost Device TrainingPatients in the experimental group will train with the Lung Boost Respiratory Trainer (MD800) for 8 weeks, three times weekly, totaling 24 sessions. The procedure will be explained, and equipment sanitized before use. Training begins in strength mode at level 1, where patients inhale deeply through a mouthpiece, with feedback provided via on-screen balls. If level 5 is easily reached, resistance increases using a cone, restarting at level 1. Sessions include 15 repetitions of 2-3 second inhalations and exhalations, performed in three sets with 15-second rests to prevent fatigue. In endurance mode, patients inhale or exhale as long as possible, progressing gradually from level 1. Each session lasts 15 minutes, divided into three sets of five breaths with 15-second rests. This structured program enhances respiratory muscle strength and endurance. | Device | Lung Boost Device Training + Traditional physical therapy program + Medical Treatment |
| Traditional physical therapy programPatients in both groups will receive a traditional physical therapy program for the chest in form of diaphragmatic breathing exercise and pursed-lip breathing exercise for 8 weeks. | Other | Lung Boost Device Training + Traditional physical therapy program + Medical Treatment, Traditional physical therapy program + Medical Treatment |
| Medical TreatmentAlso: corticosteroidsPatients in both groups will receive medical treatment for 8 weeks. | Drug | Lung Boost Device Training + Traditional physical therapy program + Medical Treatment, Traditional physical therapy program + Medical Treatment |
Primary outcome
Forced vital capacity (FVC)
Time frame: 8 weeks
It will be assessed for all participants before and after treatment, using an electronic spirometer .
The first second of forced expiration (FEV1)
Time frame: 8 weeks
It will be assessed for all participants before and after treatment, using an electronic spirometer .
FEV1/FVC ratio
Time frame: 8 weeks
It will be assessed for all participants before and after treatment, using an electronic spirometer .
Fatigue Severity Scale (FSS)
Time frame: 8 weeks
It will be used to measure fatigue severity for all participants before and after treatment. The FSS is one of the most frequently used inventories for measuring fatigue in people with chronic illnesses. The original FSS is a nine-item questionnaire developed to measure fatigue severity as a unidimensional concept. Each FSS item consists of statements that are scored on a seven-point Likert type scale, ranging from 1 ("strongly disagree") to 7 ("strongly agree").
3 secondary outcomes
oxygen saturation (SpO2)
Time frame: 8 weeks
6-min walk test (6MWT)
Time frame: 8 weeks
King's Brief Interstitial Lung Disease (K-BILD) questionnaire
Time frame: 8 weeks
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 9 Sep 2025.
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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.
Nesreen Gharib El Nahas, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Boost Device Training, Traditional physical therapy program and Medical Treatment in people with Interstitial Lung Disease, run by Cairo 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 6 inclusion and 6 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 9 Sep 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 vital capacity (FVC) (time frame: 8 weeks). The study lists 4 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 9 Sep 2025.