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

NCT ID: NCT06991153

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-29
• Study Completion Date: 2025-08-07

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.

Conditions

Interstitial Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lung Boost Device Training + Traditional physical therapy program + Medical Treatment

Twenty patients will receive respiratory training using lung boost 3 sessions per week for 8 weeks plus maintain their medical treatment.

Group Type: EXPERIMENTAL

Lung Boost Device Training

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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

Traditional physical therapy program + Medical Treatment

Twenty patient will receive traditional physical therapy program in addition to medical treatment.

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy program

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Lung 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.

Intervention Type: DEVICE

Traditional 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.

Intervention Type: OTHER

Medical Treatment

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

Intervention Type: DRUG

Other Intervention Names

corticosteroids

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Mokhtar Mahmoud Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nesreen Gharib El Nahas, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

Faculty of physical therapy, Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005083

Identifier Type: -

Identifier Source: org_study_id