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Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
NA trial testing Non-invasive ventilation(NIV) in Spinal Cord Injury in 15 participants. Completed in 1 April 2019.
| Lead sponsor | Spaulding Rehabilitation Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 14 July 2017 |
| Primary completion | 1 February 2019 |
| Estimated completion | 1 April 2019 |
| Sites | 1 location across United States |
Spaulding Rehabilitation Hospital
Adults 18 to 70, any sex, with Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
| Group | Value | 95% CI |
|---|---|---|
| Non-invasive Ventilation | 1.83 | ± 0.76 |
| Sham Ventilation | 1.82 | ± 0.64 |
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
| Group | Value | 95% CI |
|---|---|---|
| Non-invasive Ventilation | 9.6 | |
| Sham Ventilation | 10.3 |
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
| Group | Value | 95% CI |
|---|---|---|
| Non-invasive Ventilation | 38.8 | ± 9.6 |
| Sham Ventilation | 40.3 | ± 10.0 |
Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
| Group | Value | 95% CI |
|---|---|---|
| Non-invasive Ventilation | 1.6 | ± 0.3 |
| Sham Ventilation | 1.4 | ± 0.3 |
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))
1 peer-reviewed publication reference this trial (live from Europe PMC):
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