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Study to evaluate oxygen therapy effects on physical activity in patients with fibrotic interstitial lung disease who experience low oxygen levels during exercise

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with fibrotic interstitial lung disease, a condition that causes scarring of the lung tissue and makes breathing difficult. The study specifically looks at patients who experience low oxygen levels (hypoxemia) during physical activity. The treatment being investigated is oxygen therapy, which involves breathing in additional oxygen through specialized equipment.

The purpose of this research is to evaluate how oxygen therapy affects daily physical activity in patients when they exert themselves. The study measures this by tracking the number of steps patients take each day using a special device called an accelerometer. Patients will be monitored for three months to see how oxygen therapy impacts their ability to be physically active.

During the study, some participants will receive oxygen therapy while performing physical activities, while others will serve as a comparison group. The research will look at various aspects of patients' health, including their breathing difficulties, quality of life, and certain blood markers. The amount of time patients use their oxygen therapy each day will also be tracked.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your eligibility for the study will be confirmed through medical evaluation of your fibrotic interstitial lung disease diagnosis
A breathing test called 6-minute walk test will be performed to measure your oxygen levels during physical activity
Your respiratory symptoms will be evaluated to confirm stability over the previous two weeks
Step 2
Study group assignment
You will be assigned to either the control group or the intervention group
If assigned to the intervention group, you will receive oxygen therapy during physical activities
You will receive instructions on how to use the oxygen delivery system for inhalation
Step 3
Activity monitoring
You will wear an accelerometer device that counts your daily steps
The device will track your physical activity levels throughout the study period
Your daily step count will be recorded and analyzed
Step 4
Questionnaires and assessments
You will complete questionnaires about your breathing difficulties (dyspnea-12)
Your quality of life will be evaluated using a specific assessment (K-BILD)
Levels of anxiety and depression will be measured (HADS questionnaire)
Step 5
Follow-up evaluations
Your progress will be evaluated after one month of participation
A final assessment will be conducted after three months
Blood samples will be collected to analyze oxidative stress levels

Who can join the trial?

8 criteria

Must be 18 years of age or older
check
Must have been diagnosed with fibrotic interstitial lung disease, confirmed by a chest CT scan showing specific features like:
- Scarring around the edges of the lungs
- Enlarged airways due to scarring
- Decreased lung volume
- Honeycomb-like appearance in lung tissue
- Must show low oxygen levels during exercise, specifically an oxygen saturation level of 88% or lower during a 6-minute walking test when breathing regular room air
- Must have stable breathing symptoms for at least two weeks before joining the study
- Both men and women can participate

Who cannot join the trial?

11 criteria

Patients under 18 years of age
Patients who cannot perform physical activity due to severe medical conditions
Patients with unstable heart conditions (such as recent heart attack or uncontrolled heart rhythm problems)
Patients with severe pulmonary hypertension (high blood pressure in the lungs' arteries)
Patients who are currently participating in other clinical trials
Patients who are unable to use an accelerometer (step-counting device) properly
Patients who are currently using oxygen therapy at home
Patients with cognitive impairment that would prevent them from following study instructions
Patients who cannot complete the 6-minute walk test (a test measuring how far you can walk in 6 minutes)
Pregnant or breastfeeding women
Patients with other severe medical conditions that could interfere with study participation

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Investigated drugs

Oxygen therapy Oxygen therapy is a medical treatment that provides additional oxygen to patients who have difficulty getting enough oxygen naturally. In this study, it is used to help patients with lung disease breathe better during physical activities. The oxygen is typically delivered through a nasal cannula (small tubes that fit in the nose) or a mask, allowing patients to move around while receiving the supplemental oxygen they need. This therapy is particularly important for patients who experience low oxygen levels when they exercise or perform physical activities.

Oxygen

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions. The trial appears to be studying oxygen therapy, which is not a medication but rather a therapeutic intervention. The data focuses on a clinical trial examining the effects of oxygen supplementation on physical activity in patients with fibrotic interstitial lung disease, but does not list any specific medications being tested. If you'd like me to describe oxygen therapy instead, or if you have specific medications from this trial that weren't included in the provided data, please let me know.

Investigated diseases

Fibrotic Interstitial Lung Disease - A group of chronic lung disorders characterized by inflammation and scarring (fibrosis) of the lung tissue between the air sacs. The disease causes the lungs to become stiff and thick, making it increasingly difficult to breathe. The condition typically develops gradually, with progressive scarring of the delicate tissues in the lungs. As the disease advances, it affects the ability to transfer oxygen from the lungs into the bloodstream, particularly during physical activity. The scarring process can affect different parts of the lungs, including the walls of the air sacs, the airways, and the surrounding tissue.