Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

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))
    

Detailed description: 
      Regular aerobic exercise with sufficient intensity can improve overall health, however daily
      energy expenditure is low in those with SCI, especially in those with high level lesions. The
      investigators have developed Functional Electrical Stimulation Row Training (FESRT) that
      couples volitional arm and electrically controlled leg exercise, increasing the active muscle
      and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing
      aerobic capacity, those with high level lesions (C4 to T2) have a remaining obstacle to
      attaining higher work capacities. They have the greatest pulmonary muscle denervation and our
      preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT.
      External ventilatory support could improve the ability to reach higher level of peak
      ventilation and hence enhance the ability to exercise in high level SCI. Therefore, the
      investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to
      exercise, leading to increased aerobic capacity in high level SCI. The aims are to examine
      the acute effect of NIV on FES-row VO2max in subjects with both high and low level SCI. The
      investigators have access to a large (N>70) and unique population of individuals with SCI who
      have been enrolled in FESRT for at least 6 months. Roughly half have SCI between C4 and T2
      and half with lower injury levels (<T3). 15 individuals who have FES row trained for at least
      6 months will perform FES-VO2max row tests on separate days with and without the use of NIV
      to determine maximal aerobic capacity and ventilation. Both FES-VO2max Row tests will be
      performed at least 48-hours apart. Both tests will be performed with the NIV set-up but with
      and without use of the NIV support in a random order. The level of inspiratory pressure will
      be individually set during a familiarization test. The investigators will assess maximal
      aerobic capacity, minute ventilation, tidal volume and cardiac output during FES-rowing.
      Based on current data, it is hypothesized that only those with higher level of injury (> T3)
      will experience further increases in aerobic capacity when using the NIV support. This
      exploratory/developmental research project will determine feasibility and effectiveness of
      this approach to exercise and will lay the groundwork for a larger, controlled trial.
    

Intervention name(s): Non-invasive ventilation(NIV); Sham Non-invasive ventilation(NIV); Functional Electrical Stimulation Row Training (FESRT)
Intervention type(s): Device; Device; Other
Intervention description(s): 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.; 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.; FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional Electrical Stimulation (FES)-Rowing; Ventilatory support