Acute Effect of Ventilatory Support During Exercise in 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 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))
Key facts
- Study ID
- NCT03267212
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 15
- Starts
- 2017-07-14
- Expected to finish
- 2019-04-01
- Last updated by the study team
- 2020-04-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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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