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

Not Applicable

Not yet recruiting

• Conditions: Interstitial Lung Disease
• Interventions: Device: Lung Boost Device Training; Other: Traditional physical therapy program; Drug: Medical Treatment

• Registration Number: NCT06991153
• Lead Sponsor: Cairo University

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 srelated 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 Timeline

• Study First Submitted: 2024-12-03
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-26
• Last Update Posted: 2025-05-26
• Study Start: 2025-05-29
• Primary Completion: 2025-07-29
• Study Completion: 2025-08-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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, COPD, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung Boost Device Training + Traditional physical therapy program + Medical Treatment	Lung Boost Device Training	Twenty patients will receive respiratory training using lung boost 3 sessions per week for 8 weeks plus maintain their medical treatment.
Lung Boost Device Training + Traditional physical therapy program + Medical Treatment	Traditional physical therapy program	Twenty patients will receive respiratory training using lung boost 3 sessions per week for 8 weeks plus maintain their medical treatment.
Lung Boost Device Training + Traditional physical therapy program + Medical Treatment	Medical Treatment	Twenty 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	Traditional physical therapy program	Twenty patient will receive traditional physical therapy program in addition to medical treatment.
Traditional physical therapy program + Medical Treatment	Medical Treatment	Twenty patient will receive traditional physical therapy program in addition to medical treatment.

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	8 weeks	It will be assessed for all participants before and after treatment, using an electronic spirometer .
The first second of forced expiration (FEV1)	8 weeks	It will be assessed for all participants before and after treatment, using an electronic spirometer .
FEV1/FVC ratio	8 weeks	It will be assessed for all participants before and after treatment, using an electronic spirometer .
Fatigue Severity Scale (FSS)	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 Outcome Measures

Name	Time	Method
oxygen saturation (SpO2)	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.
6-min walk test (6MWT)	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.
King's Brief Interstitial Lung Disease (K-BILD) questionnaire	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.

Trial Locations

Locations (1)

Faculty of physical therapy, Cairo University; 🇪🇬 Giza, Egypt