What side effects are associated with this type of intervention?

Common treatments for lung diseases, such as Inspiratory Muscle Training (IMT), generally have minimal side effects. IMT can improve respiratory function and muscle strength with few adverse effects, primarily limited to temporary muscle soreness or fatigue. Pharmacological treatments like antibiotics and bronchodilators may cause side effects such as gastrointestinal disturbances, allergic reactions, and increased heart rate. Corticosteroids can lead to weight gain, osteoporosis, and increased infection risk. Physical therapy and supportive care are generally safe but may cause temporary discomfort or fatigue.

What prior FDA approvals exist?

FDA-approved treatments for lung diseases that enhance respiratory function include bronchodilators like salbutamol and ipratropium bromide, which improve exercise capacity and reduce bronchoconstriction. While Inspiratory Muscle Training (IMT) itself is not specifically mentioned as FDA-approved, it is a widely studied method to improve respiratory muscle strength, exercise capacity, and quality of life in patients with advanced lung disease. Other related treatments include glucocorticoids for reducing inflammation and improving pulmonary function in conditions like COPD.

What other types of research exist?

Promising novel alternatives to Inspiratory Muscle Training for lung disease patients include: 1) Noninvasive Ventilatory Support (NIV) which can help manage nocturnal hypoventilation and improve overall respiratory function. 2) Mechanical Insufflation-Exsufflation (MIE) which assists in clearing airway secretions and can be particularly beneficial during respiratory infections. 3) Diaphragm Pacing, which involves electrical stimulation of the diaphragm to enhance respiratory muscle function, especially in patients with specific neuromuscular conditions.

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Inspiratory Muscle Training for Lung Transplant Recovery

N/A

Recruiting

Led By Cristiane Meirelles, PT, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

Be older than 18 years old

Must not have

Impaired cognition with inability to follow commands

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the groups will be assessed: before lung transplantation, 8 weeks, 6 and 12 months after ltx

Summary

This trial is testing a special breathing exercise device for people who have had a lung transplant. The device helps strengthen the muscles used for breathing. The goal is to help these patients breathe better, feel less tired, and improve their ability to do everyday activities.

Who is the study for?

This trial is for people waiting for a lung transplant who can walk (even with help) and understand the study. They shouldn't have cognitive issues that make it hard to follow instructions or already be doing inspiratory muscle training.

What is being tested?

The study tests if using an inspiratory muscle trainer right after a lung transplant helps patients breathe better, feel less tired, and improve their daily activities compared to those who only get standard physical therapy.

What are the potential side effects?

Since this trial involves non-invasive breathing exercises, side effects are minimal but may include temporary increased fatigue or discomfort from the use of the training device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk by myself or with help from a device.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I struggle to understand or follow instructions due to cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the groups will be assessed: before lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after ltx

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the groups will be assessed: before lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after ltx

This trial's timeline: 3 weeks for screening, Varies for treatment, and the groups will be assessed: before lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after ltx for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fatigue: Fatigue Severity Scale

Change in functional capacity

Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O

+1 more

Secondary study objectives

Change in grip strength

Change in lower extremity muscle strength

Change in lung function: Pulmonary Function Test

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Inspiratory Muscle training- Intervention groupExperimental Treatment1 Intervention

Along with standard post-transplant physical therapy, the intervention group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with weekly incremental increases in respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Group II: Usual care groupActive Control1 Intervention

Patients will only participate in standard post-transplant physical therapy.

Group III: Inspiratory Muscle training - Placebo groupPlacebo Group1 Intervention

Along with standard post-transplant physical therapy, the placebo group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with no increase of respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung disease include bronchodilators, anti-inflammatory medications, and respiratory muscle training. Bronchodilators, such as beta agonists and muscarinic antagonists, work by relaxing the muscles around the airways, making breathing easier. Anti-inflammatory medications, like inhaled corticosteroids, reduce inflammation and swelling in the airways, improving airflow. Inspiratory muscle training (IMT) specifically targets the strengthening of respiratory muscles, enhancing their endurance and efficiency. This is particularly important for lung disease patients as it can improve exercise capacity, reduce dyspnea, and enhance overall quality of life by making daily activities less exhausting.

Inspiratory muscle training in patients with heart failure: a systematic review.Tutorial on maximum inspiratory and expiratory mouth pressures in individuals with idiopathic Parkinson disease (IPD) and the preliminary results of an expiratory muscle strength training program.