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Completed

NCT Number: NCT06991153

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

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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Lung Boost Device Training

Device

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 program

Other

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 treatment

Drug

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

Other names: corticosteroids

Primary outcomes

  1. Forced vital capacity (FVC)

    Time frame: 8 weeks

    It will be assessed for all participants before and after treatment, using an electronic spirometer .

  2. 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 .

  3. FEV1/FVC ratio

    Time frame: 8 weeks

    It will be assessed for all participants before and after treatment, using an electronic spirometer .

  4. 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").

Secondary outcomes

  1. oxygen saturation (SpO2)

    Time frame: 8 weeks

    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.

  2. 6-min walk test (6MWT)

    Time frame: 8 weeks

    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.

  3. King's Brief Interstitial Lung Disease (K-BILD) questionnaire

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 26, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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