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Rehab and Mechanical Ventilation

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07427121
Acronym
REHAB-MV
Enrollment
16
Registered
2026-02-23
Start date
2026-03-30
Completion date
2027-12-31
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inspiratory Strength Training (IST), Sham Spinal Stimulation, Transcutaneous Spinal Stimulation

Keywords

diaphragm, phrenic nerve, maximal inspiratory pressure, mechanical ventilation

Brief summary

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.

Detailed description

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.

Interventions

DEVICESpinal cord stimulation

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

BEHAVIORALInspiratory Strength Training

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

OTHERSham Stimulation

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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal inspiratory pressureT1: baseline strength, T2: 2 hours after MV, T3: 24 hours after MVThe most negative pressure generated during a maximal inspiratory effort.
Phrenic CMAP Responseup to 24 hoursEMG response to supra maximal and bilateral phrenic stimulation

Secondary

MeasureTime frameDescription
Diaphragm thickness and excursionup to 24 hoursDiaphragm thickness and excursion will be computed during resting breathing and during inspiratory efforts.

Countries

United States

Contacts

CONTACTBarbara K Smith, PhD, PT
bksmith@ufl.edu352-294-5315
CONTACTUshna Khan, MD
ushnakhan@ufl.edu352-273-6855
PRINCIPAL_INVESTIGATORBarbara K Smith, PhD

University of Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026