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

NCT06991153 | Completed

• 1 other identifier: P.T.REC/012/005083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (4)

• Forced vital capacity (FVC)

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

  8 weeks

• The first second of forced expiration (FEV1)

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

  8 weeks

• FEV1/FVC ratio

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

  8 weeks

• Fatigue Severity Scale (FSS)

  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").

  8 weeks

Secondary Outcomes (3)

• oxygen saturation (SpO2)

  8 weeks

• 6-min walk test (6MWT)

  8 weeks

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

  8 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Device: Lung Boost Device Training; Other: Traditional physical therapy program; Drug: Medical Treatment

Traditional physical therapy program + Medical Treatment

ACTIVE COMPARATOR

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

Other: Traditional physical therapy program; Drug: Medical Treatment

Interventions

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.

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

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.

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

Medical Treatment DRUG

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

Also known as: corticosteroids

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

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nesreen Gharib El Nahas, PhD

  Professor, Cairo university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: May 26, 2025
• Study Start: May 29, 2025
• Primary Completion: July 29, 2025
• Study Completion: August 7, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

EG (1)