Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
Completed · Not applicable · Has a placebo group
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT02865343
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 11
- Starts
- 2017-02-22
- Expected to finish
- 2019-06-28
- Last updated by the study team
- 2023-02-09
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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