Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

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))

Conditions

• Spinal Cord Injury

Interventions

DEVICE

Non-invasive ventilation(NIV)

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.

DEVICE

Sham Non-invasive ventilation(NIV)

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.

OTHER

Functional Electrical Stimulation Row Training (FESRT)

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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital

  lead OTHER

Principal Investigators

• J. Andrew Taylor, PhD · Spaulding Rehabilitation Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-14

Primary Completion

2019-02-01

Completion

2019-04-01

FDA Device

Yes

Countries

• United States

Study Locations