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Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury (NIV-Ex-CS)

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ClinicalTrials.gov Identifier: NCT03267212
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
J. Andrew Taylor, Spaulding Rehabilitation Hospital

August 22, 2017
August 30, 2017
April 18, 2018
June 14, 2017
September 2018   (Final data collection date for primary outcome measure)
Change in Peak Aerobic Capacity during FES-row testing [ Time Frame: Day 0 and Day 2 ]
Volunteers will perform a 2 separate maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests with and without use of the NIV-machine.
Same as current
Complete list of historical versions of study NCT03267212 on ClinicalTrials.gov Archive Site
  • Change in cardiac output during FES-row testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers will perform a 2 separate high intensity sub-maximal steady-state FES-row tests. Both NIV Support and Sham-NIV groups will perform tests with and without use of the NIV-machine set at the same level as used during their training.
  • Change in minute ventilation during FES-row testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers will perform a 2 separate maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests with and without use of the NIV-machine.
  • Change in tidal volume during FES-row testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers will perform a 2 separate maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests with and without use of the NIV-machine.
Same as current
Not Provided
Not Provided
 
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
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))
Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. The investigators have developed Functional Electrical Stimulation Row Training (FESRT) that couples volitional arm and electrically controlled leg exercise, increasing the active muscle and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing aerobic capacity, those with high level lesions (C4 to T2) have a remaining obstacle to attaining higher work capacities. They have the greatest pulmonary muscle denervation and our preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT. External ventilatory support could improve the ability to reach higher level of peak ventilation and hence enhance the ability to exercise in high level SCI. Therefore, the investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic capacity in high level SCI. The aims are to examine the acute effect of NIV on FES-row VO2max in subjects with both high and low level SCI. The investigators have access to a large (N>70) and unique population of individuals with SCI who have been enrolled in FESRT for at least 6 months. Roughly half have SCI between C4 and T2 and half with lower injury levels (<T3). 15 individuals who have FES row trained for at least 6 months will perform FES-VO2max row tests on separate days with and without the use of NIV to determine maximal aerobic capacity and ventilation. Both FES-VO2max Row tests will be performed at least 48-hours apart. Both tests will be performed with the NIV set-up but with and without use of the NIV support in a random order. The level of inspiratory pressure will be individually set during a familiarization test. The investigators will assess maximal aerobic capacity, minute ventilation, tidal volume and cardiac output during FES-rowing. Based on current data, it is hypothesized that only those with higher level of injury (> T3) will experience further increases in aerobic capacity when using the NIV support. This exploratory/developmental research project will determine feasibility and effectiveness of this approach to exercise and will lay the groundwork for a larger, controlled trial.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Investigators and technicians helping for performing the test and encouraging the patient will be blind. Only one investigator will monitor the ventilation during the test and won't be blind but won't be participating to any encouragement or data acquisition.
Primary Purpose: Treatment
Spinal Cord Injury
  • Device: Non-invasive ventilation(NIV)
    The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
  • Device: Sham Non-invasive ventilation(NIV)
    The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
  • Other: Functional Electrical Stimulation Row Training (FESRT)
    FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
  • Active Comparator: Non-invasive Ventilation(NIV)
    Subjects will perform FES-row testing while receiving bi-level positive airway pressure ventilation applied through a full face-mask.
    Interventions:
    • Device: Non-invasive ventilation(NIV)
    • Other: Functional Electrical Stimulation Row Training (FESRT)
  • Sham Comparator: Sham Non-invasive ventilation(NIV)
    Subjects will perform FES-row testing while receiving sham ventilation applied through a full face-mask.
    Interventions:
    • Device: Sham Non-invasive ventilation(NIV)
    • Other: Functional Electrical Stimulation Row Training (FESRT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Same as current
September 2019
September 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact: Isabelle Vivodtzev, PhD 6177585504 IVivodtzev@partners.org
Contact: Glen Picard, MA 617-758-5511 gpicard@partners.org
United States
 
 
NCT03267212
SpauldingRH-2
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
J. Andrew Taylor, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Not Provided
Principal Investigator: J. Andrew Taylor, PhD Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP