Clinical trial NCT06991153: Impact of Lung Boost Device on Ventilatory Functions and Fatigue in Patients With Interstitial Lung Diseases
Official title: Impact of Lung Boost Device on Ventilatory Functions and Fatigue in Patients With Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 8 weeks
measure: The first second of forced expiration (FEV1)
timeFrame: 8 weeks
measure: FEV1/FVC ratio
timeFrame: 8 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 8 weeks
Secondary outcomes:
measure: oxygen saturation (SpO2)
timeFrame: 8 weeks
measure: 6-min walk test (6MWT)
timeFrame: 8 weeks
measure: King's Brief Interstitial Lung Disease (K-BILD) questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo University
Study officials:
affiliation: Professor, Cairo university
name: Nesreen Gharib El Nahas, PhD
role: STUDY_CHAIR
References: