Ventilatory Support to Improve Exercise Training in High Level 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 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 4 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.

Study Start Date

February, 22 2017

Estimated Completion Date

September 2019

Interventions

  • Device: Sham Non-invasive ventilation(NIV)
  • Device: Non-invasive Ventilation(NIV)

Study ID

Spaulding Rehabilitation Hospital -- SpauldingRH

Status

Recruiting

Trial ID

NCT02865343

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

30

Sponsor

Spaulding Rehabilitation Hospital

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

Gender

All

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

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
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
Spaulding Hospital Cambridge - Cambridge, Massachusetts 2.6 miles Glen Picard MA 617-758-5511 gpicard@partners.org

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