N/A
N=15
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT03267212 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Peak Aerobic Capacity During FES-row Testing — 1.83; 1.82 L/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-invasive ventilation(NIV) (Device); Sham Non-invasive ventilation(NIV) (Device); Functional Electrical Stimulation Row Training (FESRT) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Aerobic Capacity During FES-row Testing |
1.83; 1.82 | — |
| SECONDARY Change in Cardiac Output During FES-row Testing |
9.6; 10.3 | — |
| SECONDARY Change in Minute Ventilation During FES-row Testing |
38.8; 40.3 | — |
| SECONDARY Change in Tidal Volume During FES-row Testing |
1.6; 1.4 | — |
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))
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18 to 70 (IRB amendment to change maximal age from 60 to 70 years old approved on 9/20/17)
- Have had SCI (at neurological level C5-T12 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 (NCT03267212). 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.