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Impact of Lung Boost Device on Ventilatory Functions and Fatigue in Patients With Interstitial Lung Diseases

Impact of Lung Boost Device on Ventilatory Functions and Fatigue in Patients With Interstitial Lung Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06991153
Enrollment
40
Registered
2025-05-26
Start date
2025-05-29
Completion date
2025-08-07
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Brief 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.

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.

Interventions

DEVICELung Boost Device Training

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.

OTHERTraditional physical therapy program

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.

DRUGMedical Treatment

Patients in both groups will receive medical treatment for 8 weeks.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Forty female patients have Interstitial lung disease . 2. All patients diagnosed as ILD on clinical and radiological basis. 3. Age will range between 45 to 55 years old . 4. All patients will be with mild hypoxemia range from 90 to 92 oxygen saturation 5. They have Interstitial lung disease for at least 3 years ago. 6. Stable in medical and hemodynamic state

Exclusion criteria

1. Cardiovascular (as acute heart failure, unstable angina or recent myocardial infarction) 2. Patients with other significant respiratory disorders such as acute infections, pulmonary tuberculosis, chronic obstructive pulmonary disease, asthma, bronchiectasis, lung carcinoma, and pneumothorax. 3. cognitive impairments, history of cerebrovascular accident, active cancer will be excluded. 4. Hepatitis, cirrhosis. 5. Current treatment for cancer or active infection 6. Orthopedic problem.

Design outcomes

Primary

MeasureTime frameDescription
Forced vital capacity (FVC)8 weeksIt will be assessed for all participants before and after treatment, using an electronic spirometer .
The first second of forced expiration (FEV1)8 weeksIt will be assessed for all participants before and after treatment, using an electronic spirometer .
FEV1/FVC ratio8 weeksIt will be assessed for all participants before and after treatment, using an electronic spirometer .
Fatigue Severity Scale (FSS)8 weeksIt 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).

Secondary

MeasureTime frameDescription
6-min walk test (6MWT)8 weeksIt 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.
King's Brief Interstitial Lung Disease (K-BILD) questionnaire8 weeksIt 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.
oxygen saturation (SpO2)8 weeksIt 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026