Ventilatory Support to Improve Exercise Training in High Level 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 FES-RT for at least 6
      months. Roughly half have high level SCI. Thirty individuals with high level SCI who have
      FES-row trained for at least 6 months will be randomized to (continued) FES-RT for 3 months
      with either NIV or sham NIV. Before and after training, the investigators will assess maximal
      aerobic capacity, ventilation, cardiac output, and arterio-venous oxygen difference. Based on
      the investigators current data, it is hypothesized that only those randomized to NIV will
      experience further increases in aerobic capacity and that these increases will relate to
      increases in cardiac output and arterio-venous oxygen difference. This
      Exploratory/Developmental Research project will lay the groundwork for a larger study of the
      impact of FES-RT+NIV to improve health and function in those with high level SCI.
    

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. We
      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 exercise train and hence enhance the
      adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during
      exercise training has been shown to improve gains in exercise capacity in those with
      similarly restrictive breathing. 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. Our aims are to determine the magnitude of improvement in aerobic
      capacity and its relationship to increases in maximal cardiac output and arterio venous
      oxygen difference after 3 months of FESRT+NIV compared to FESRT+shamNIV. 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. 30
      individuals with high level SCI who have FES row trained for at least 6 months will be
      randomized to (continued) FESRT for 3 months with either NIV or sham NIV. Before and after
      training, the investigators will assess maximal aerobic capacity, ventilation, cardiac
      output, and arterio venous oxygen difference. Based on our current data, it is hypothesized
      that only those randomized to NIV will experience further increases in aerobic capacity and
      that these increases will relate to increased cardiac output and arterio venous oxygen
      difference. 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)
Intervention type(s): Device; Device
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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional Electrical Stimulation (FES)-Rowing