CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Non-invasive ventilation(NIV) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03267212
NCT03267212N/ACompleted

Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

Spaulding Rehabilitation Hospital·interventional·Posted Aug 30, 2017·Updated Apr 9, 2020

In Brief

A clinical study evaluating Non-invasive ventilation(NIV), Sham Non-invasive ventilation(NIV), and 1 other intervention for Spinal Cord Injury. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The investigators have an existing exercise program (N\>70) with a unique population of individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory from this exercise platform has recently showed that respiratory restriction in SCI reduces inspiratory capacity in direct relation to lesion level, and those with high level injuries have the greatest compromise. As a result, the increase in ventilatory requirements with FES training results in an imbalance between ventilatory capacity and greater whole body skeletal muscle demand after FES rowing training. Hence, external ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. If our hypothesis is correct, this indicates that maximal aerobic capacity in these individuals exceeds maximal voluntary ventilation. It will be important to determine however the consistency of this response and at what level of injury it is not observed. In parallel of the study # NCT02865343, the investigators will recruit here a population of subjects who have completed six months of FES-row exercise training across a range of SCI level (C5-T12). Hence, the investigators will be able to determine the consistency of the effect and the dependence of the effect on SCI level. Some of them with level \>T3 may also enroll in training effect study with NIV or sham NIV (NCT02865343))

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 30, 2017
Enrollment StartJul 14, 2017
Primary CompletionFeb 1, 2019
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.8 years ago

Interventions

Non-invasive ventilation(NIV)device

The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.

Sham Non-invasive ventilation(NIV)device

The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.

Functional Electrical Stimulation Row Training (FESRT)other

FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training