Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07427121

Rehab and Mechanical Ventilation

The goal of this research study is to evaluate the effects of a single session of rehabilitation in healthy adults, before noninvasive mechanical ventilation (MV). MV can help support breathing function during sleep or illness. High levels of MV support have been reported to alter the function of the diaphragm muscle, the primary breathing muscle, in people with compromised health. However, rehabilitation may have some potential to improve diaphragm function in advance of using MV. This study will test different rehabilitation interventions, including (1) inspiratory strength training (IST), (2) transcutaneous spinal cord stimulation (TSCS), or sham TSCS. Before and after MV, participants will complete breathing strength tests and responses to phrenic nerve stimulation.

Recruiting

Interested in participating?

Request Info

Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Brief periods of mechanical ventilation (MV) can degrade the function of the diaphragm, which can be a problem for older adults and people with multiple medical comorbidities. 20% of people who are placed on MV require a prolonged effort to wean back to independent breathing. The effects of MV on respiratory neural function are often unaddressed by typical clinical practices. Many aspects of clinical practice such as MV, anesthesia, opioid medication directly reduce respiratory neural drive and degrade diaphragm fiber contractile function, and these impairments can occur rapidly, persist after extubation, and increase the risk for postoperative pulmonary complications. These complications delay discharge, incur significant expenses, and place patients at risk for an incomplete recovery and significant morbidity. Thus, any rehabilitation strategies to preserve or improve phrenic/diaphragm motor function have the potential to expedite early post-operative mobilization and reduce the risk of complications.

Inspiratory muscle strength training (IST) is an effective rehabilitation method to strengthen the diaphragm muscle. Repetitive IST reinforces respiratory neuromuscular plasticity, induces diaphragm remodeling, and improves inspiratory strength. Bouts of high intensity inspiratory loading acutely increase respiratory neural drive and potentiates inspiratory motor recruitment. Additionally, in some clinical situations, IST exercise is not feasible, thus another option may be electrical stimulation of the diaphragm/phrenic motor area (C3-C6) to generate similar improvements in inspiratory drive to preserve breathing function.

The central hypothesis of this proposal is that rehabilitation to increase diaphragm excitability in advance of MV will offset post-MV inspiratory dysfunction. To test this hypothesis, a repeated-measures, blinded study of healthy adults without respiratory comorbidities will be recruited. Consenting participants will complete a familiarization session, followed by three separate, two-hour noninvasive MV sessions, one week apart. MV sessions will be preceded by: 1) a single, high-intensity IST session, and 2) transcutaneous spinal cord stimulation, and 3) sham electrical stimulation, in randomized order. Changes in respiratory drive, voluntary and evoked diaphragm strength, and dyspnea will be evaluated. The central hypothesis will be tested with the following aims:

Aim 1: Test the hypothesis that noninvasive, positive pressure ventilation acutely decreases respiratory drive and maximal diaphragm activation during a two-hour MV session and persists up to 24 hours later.

Aim 2: Test the hypothesis that even single rehabilitation sessions (IST, transcutaneous stimulation) in advance of MV will preserve evoked diaphragm recruitment and hasten early recovery from MV, when compared to sham stimulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Non-smokers Sedentary or recreationally active Normal lung function No history of claustrophobia

Exclusion criteria

Current smoking or vaping Obstructive lung disease Use of antibiotics or systemic corticosteroids to treat an acute condition History of sepsis or metastatic disease Post infectious conditions that affect breathing Diagnosed with a neurological or neuromuscular condition Any use of supplemental oxygen, continuous positive airway pressure (CPAP), or other positive pressure ventilation to treat sleep apnea Cardiac disease Orthopedic conditions that impair lung expansion Pregnancy Implanted metallic devices within 10 cm of the cervical spine

Treatment and study plan

Spinal Cord Stimulation

Device

Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.

Inspiratory Strength Training

Behavioral

5 sets of 5 breaths of high-intensity inspiratory strength training

Sham stimulation

Other

Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.

Primary outcomes

  1. Maximal inspiratory pressure

    Time frame: T1: baseline strength, T2: 2 hours after MV, T3: 24 hours after MV

    The most negative pressure generated during a maximal inspiratory effort.

  2. Phrenic CMAP Response

    Time frame: up to 24 hours

    EMG response to supra maximal and bilateral phrenic stimulation

Secondary outcomes

  1. Diaphragm thickness and excursion

    Time frame: up to 24 hours

    Diaphragm thickness and excursion will be computed during resting breathing and during inspiratory efforts.

Other outcomes

  1. Two-minute step test (2M-ST)

    Time frame: Two hours and twenty-four hours post-MV.

    Participants will step in place as quickly as possible for two minutes, lifting the thigh a vertical height midway between the anterior superior iliac spine and the center of the patella.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara K Smith, PhD, PT

CONTACT

[email protected]

352-294-5315

Ushna Khan, MD

CONTACT

[email protected]

352-273-6855

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Rehabilitation-based Approaches to Prevent Mechanical Ventilation-induced Breathing Dysfunction

Acronym: REHAB-MV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.