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Clinical Trial NCT07427121 (REHAB-MV) for Inspiratory Strength Training (IST), Transcutaneous Spinal Stimulation, Sham Spinal Stimulation is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Rehab and Mechanical Ventilation (REHAB-MV) 16

Not yet recruiting
Clinical Trial NCT07427121 (REHAB-MV) is an interventional study for Inspiratory Strength Training (IST), Transcutaneous Spinal Stimulation, Sham Spinal Stimulation and is currently not yet recruiting. Enrollment is planned to begin on 10 March 2026 and continue until the study accrues 16 participants. Led by University of Florida, this study is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 27 February 2026.
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 so...Show More
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...Show More
Official Title

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

Conditions
Inspiratory Strength Training (IST)Transcutaneous Spinal StimulationSham Spinal Stimulation
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • REHAB-MV
  • IRB202501849
NCT ID Number
NCT07427121
Start Date (Actual)
2026-03-10
Last Update Posted
2026-02-27
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
16
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
diaphragm
phrenic nerve
maximal inspiratory pressure
mechanical ventilation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Sham ComparatorSham Stimulation
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
Sham Stimulation
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
Active ComparatorSpinal cord stimulation
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
Spinal cord stimulation
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
ExperimentalInspiratory strength training
5 sets of 5 breaths of high-intensity inspiratory strength training
Inspiratory Strength Training
5 sets of 5 breaths of high-intensity inspiratory strength training
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Maximal inspiratory pressure
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
EMG response to supra maximal and bilateral phrenic stimulation
up to 24 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diaphragm thickness and excursion
Diaphragm thickness and excursion will be computed during resting breathing and during inspiratory efforts.
up to 24 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

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

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
University of Florida logoUniversity of Florida
Study Central Contact
Contact: Barbara K Smith, PhD, PT, 352-294-5315, [email protected]
Contact: Ushna Khan, MD, 352-273-6855, [email protected]
1 Study Locations in 1 Countries

Florida

University of Florida, Gainesville, Florida, 32610, United States