N/A
N=11
Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02865343 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Change in Baseline Aerobic Capacity After 3 Months of FES-row Training. — 0.21; 0.08 L/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-invasive Ventilation(NIV) (Device); Sham Non-invasive ventilation(NIV) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline Aerobic Capacity After 3 Months of FES-row Training. |
0.21; 0.08 | — |
| SECONDARY Change in Peak Cardiac Output After 3 Months of FES-row Training. |
2.8; -2.2 | — |
| SECONDARY Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training |
1.4; 3.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18 to 60
- Have had high level SCI (neurological level ≥T3 with American Spinal Injury Association grade A or B or C)
- Medically stable
- Have FES-row trained for >6 months
Exclusion Criteria
- Hypertension(Blood pressure>140/90 mmHg)
- Significant arrhythmias
- Coronary disease
- Chronic respiratory disease
- Diabetes
- Renal disease
- Cancer
- Epilepsy
- Current use of cardioactive medications
- Current grade 2 or greater pressure ulcers at relevant contact sites
- Other neurological disease
- Peripheral nerve compression or rotator cuff tears that limit the ability to row
- History of bleeding disorder
Data sourced from ClinicalTrials.gov (NCT02865343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.