16 Participants NeededMy employer runs this trial

Rehabilitation for Breathing Support

(REHAB-MV Trial)

BK
UK
Overseen ByUshna Khan, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a single session of rehabilitation might improve breathing muscle function before using noninvasive mechanical ventilation (a machine that assists breathing). It will test three methods: inspiratory strength training (breathing exercises), spinal cord stimulation (a technique using electrical pulses), and a sham version (a placebo for comparison). Healthy adults who do not smoke, are not very active, and have normal lung function may qualify for this trial. Participants should have no history of lung diseases or use devices like CPAP for sleep apnea.

As an unphased trial, this study provides a unique opportunity to contribute to foundational research that could enhance future respiratory therapies.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using antibiotics or systemic corticosteroids for an acute condition, you would not be eligible to participate.

What prior data suggests that these rehabilitation interventions are safe for breathing support?

Research has shown that inspiratory strength training (IST) is safe and generally well-tolerated. Studies have demonstrated that it can increase the strength of breathing muscles without causing major side effects. For instance, one study found that IST improved muscle strength and reduced symptoms in people with certain health conditions. Another study confirmed its safety and effectiveness in enhancing breathing abilities.

Regarding transcutaneous spinal cord stimulation (TSCS), research suggests it is also safe for improving the function of breathing muscles. Studies have found that TSCS helps strengthen these muscles without significant negative side effects. No reports have indicated harmful effects from using TSCS to help people with spinal cord injuries breathe better.

Both treatments—IST and TSCS—show promise in safely supporting respiratory health.12345

Why are researchers excited about this trial?

Researchers are excited about the Rehabilitation for Breathing Support trial because it explores innovative techniques to enhance breathing strength, which could revolutionize respiratory care. Unlike traditional treatments like bronchodilators or oxygen therapy, this trial examines inspiratory strength training and spinal cord stimulation, which aim to directly improve the muscles involved in breathing. Inspiratory strength training involves high-intensity exercises that could significantly boost lung capacity and efficiency more rapidly than current options. The spinal cord stimulation technique uses electrical impulses to potentially enhance respiratory muscle function, offering a novel approach that could complement or even replace standard treatments. This trial could pave the way for more effective, less invasive breathing support methods.

What evidence suggests that this trial's treatments could be effective for improving diaphragm function?

Research has shown that inspiratory strength training (IST), one of the treatments in this trial, can significantly enhance the strength of the muscles used for breathing. This improvement allows for easier breathing, reduced shortness of breath, and increased energy for exercise. Many studies have confirmed that IST boosts the power of these breathing muscles and overall lung function.

Similarly, transcutaneous spinal cord stimulation (TSCS), another treatment option in this trial, has demonstrated potential in strengthening breathing muscles, particularly for individuals with spinal cord injuries. Research has found that TSCS can enhance breathing efficiency and the strength of breathing muscles. These findings suggest that both IST and TSCS, as separate treatment arms in this trial, can support better breathing in distinct ways.25678

Who Is on the Research Team?

BK

Barbara K Smith, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not smoke, are either sedentary or only lightly active, have normal lung function, and no history of claustrophobia.

Inclusion Criteria

I do not smoke, have normal lungs, am not claustrophobic, and am at most moderately active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Familiarization

Participants complete a familiarization session to understand the procedures and interventions

1 session

Treatment

Participants undergo three separate, two-hour noninvasive MV sessions, each preceded by a different intervention: high-intensity IST, transcutaneous spinal cord stimulation, or sham stimulation

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for changes in respiratory drive, diaphragm strength, and dyspnea up to 24 hours post-MV

24 hours post each MV session

What Are the Treatments Tested in This Trial?

Interventions

  • Inspiratory Strength Training
  • Sham Stimulation
  • Spinal cord stimulation

Trial Overview

The study tests if a single session of breathing muscle training or spinal cord stimulation (real or sham) can improve diaphragm strength before using noninvasive mechanical ventilation. Participants are randomly assigned to one of the interventions.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Inspiratory strength trainingExperimental Treatment1 Intervention
Group II: Spinal cord stimulationActive Control1 Intervention
Group III: Sham StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

The Effectiveness of Respiratory Muscle Training on ... - PMC

By reducing the respiratory rate, increasing diaphragmatic excursion, and improving the efficiency of respiratory muscles, RMT is expected to decrease the work ...

Evaluating the Impact of Inspiratory Muscle Training on ... - PMC

IMT enhances respiratory muscle strength, which leads to better ventilatory efficiency, reduced dyspnea, and improved exercise capacity in different ...

Effectiveness of inspiratory muscle training in patients with ...

IMT improved several clinically relevant outcomes, including MIP, exercise capacity, and dyspnoea in different CRDs.

Effectiveness of Inspiratory Muscle Training on Respiratory ...

There is strong evidence that IMT improves inspiratory muscle strength, pulmonary function, and functional capacity, and reduces the length of ...

Full article: Effectiveness of Respiratory Muscle Training on ...

Respiratory muscle training could potentially improve muscle strength and pulmonary functions of subjects after stroke.

12-Week Inspiratory Muscle Training Improves Respiratory ...

This study aims to investigate and compare the effects of conventional breathing exercises and an inspiratory muscle training intervention on clinical ...

Effectiveness and safety of inspiratory muscle training in ...

Inspiratory muscle training (IMT) is a simple and well-tolerated physical therapy that increases respiratory muscle strength and relieving the ...

Optimizing Inspiratory Muscle Training: The BREATHS ...

This framework is designed to upskill physical therapists and other health care providers with a contemporary model to deliver safe, effective, and evidence- ...