Rehab and Mechanical Ventilation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-80
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

16 Participants
are divided into 3 treatment groups
Group A: Sham StimulationSham comparator 1 intervention
Group B: Spinal cord stimulationActive comparator 1 intervention
Group C: Inspiratory strength trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximal inspiratory pressure

The most negative pressure generated during a maximal inspiratory effort.

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

Phrenic CMAP Response

EMG response to supra maximal and bilateral phrenic stimulation

Time frame
up to 24 hours

Secondary outcomes

1

Diaphragm thickness and excursion

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

Time frame
up to 24 hours

Other outcomes

1

Two-minute step test (2M-ST)

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.

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

Sponsors and contacts

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