Rehab and Mechanical Ventilation (REHAB-MV)

April 29, 2026 updated by: University of Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Barbara K Smith, PhD, PT
  • Phone Number: 352-294-5315
  • Email: bksmith@ufl.edu

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Stimulation
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
Other: Sham Stimulation
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
Active Comparator: Spinal cord stimulation
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
Device: Spinal cord stimulation
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
Experimental: Inspiratory strength training
5 sets of 5 breaths of high-intensity inspiratory strength training
Behavioral: Inspiratory Strength Training
5 sets of 5 breaths of high-intensity inspiratory strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
T1: baseline strength, T2: 2 hours after MV, T3: 24 hours after MV
Phrenic CMAP Response
Time Frame: up to 24 hours
EMG response to supra maximal and bilateral phrenic stimulation
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm thickness and excursion
Time Frame: up to 24 hours
Diaphragm thickness and excursion will be computed during resting breathing and during inspiratory efforts.
up to 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two hours and twenty-four hours post-MV.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Barbara K Smith, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202501849

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant data that underlie the results reported in this article after deidentification.

IPD Sharing Time Frame

9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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