Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

Description

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))

Study Start Date

June, 14 2017

Estimated Completion Date

September 2019

Interventions

  • Other: Functional Electrical Stimulation Row Training (FESRT)
  • Device: Non-invasive ventilation(NIV)
  • Device: Sham Non-invasive ventilation(NIV)

Study ID

Spaulding Rehabilitation Hospital -- SpauldingRH-2

Status

Recruiting

Trial ID

NCT03267212

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

15

Sponsor

Spaulding Rehabilitation Hospital

Inclusion Criteria

  • Subjects aged 18 to 60
  • 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

Gender

All

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Spaulding Hospital Cambridge - Cambridge, Massachusetts 2.6 miles Glen Picard MA 617-758-5511 gpicard@partners.org
Spaulding Hospital Cambridge - Cambridge, Massachusetts 2.6 miles Glen Picard MA 617-758-5511 gpicard@partners.org

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