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Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury (NIV-Ex)

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ClinicalTrials.gov Identifier: NCT02865343
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
J. Andrew Taylor, Spaulding Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Non-invasive Ventilation(NIV) Device: Sham Non-invasive ventilation(NIV) Not Applicable

Detailed Description:
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. We 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 exercise train and hence enhance the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during exercise training has been shown to improve gains in exercise capacity in those with similarly restrictive breathing. 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. Our aims are to determine the magnitude of improvement in aerobic capacity and its relationship to increases in maximal cardiac output and arterio venous oxygen difference after 4 months of FESRT+NIV compared to FESRT+shamNIV. 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. 30 individuals with high level SCI who have FES row trained for at least 6 months will be randomized to (continued) FESRT 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 our 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 increased cardiac output and arterio venous oxygen difference. 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel 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
Official Title: Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Non-invasive Ventilation(NIV)
Subjects randomized to NIV will perform 12-weeks of FES-row training while receiving bi-level positive airway pressure ventilation applied through a full face-mask.
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.
Placebo Comparator: Sham Non-invasive ventilation(NIV)
Subjects randomized to Sham-NIV will perform 12-weeks of FES-row training while receiving sham ventilation applied through a full face-mask.
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.



Primary Outcome Measures :
  1. Change in Baseline Aerobic Capacity after 3 Months of FES-row Training. [ Time Frame: Baseline and 3 months ]
    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 set at the same level as used during their training.


Secondary Outcome Measures :
  1. Change in Baseline Peak Cardiac Output after 3 Months of FES-row Training. [ Time Frame: Baseline and 3 months ]
    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.

  2. Change in Baseline Peak Minute Ventilation during exercise after 3 Months of FES-row Training [ Time Frame: Baseline and 3 months ]
    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 set at the same level as used during their training.

  3. Change in Baseline Forced Vital Capacity Test after 3 Months of FES-row Training [ Time Frame: Baseline and 3 months ]
    Spirometry will be used to measure lung function, specifically forced vital capacity.

  4. Change in Baseline Maximal Voluntary Ventilation Test after 3 Months of FES-row Training. [ Time Frame: Baseline and 3 months ]
    Spirometry will be used to measure lung function, specifically maximal voluntary ventilation.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865343


Contacts
Contact: Isabelle Vivodtzev, PhD 6177585504 IVivodtzev@partners.org
Contact: Glen Picard, MA 617-758-5511 gpicard@partners.org

Locations
United States, Massachusetts
Spaulding Hospital Cambridge Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Glen Picard, M.A.    617-758-5511    gpicard@partners.org   
Principal Investigator: J. Andrew Taylor, Ph.D.         
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: J. Andrew Taylor, PhD Spaulding Rehabilitation Hospital

Responsible Party: J. Andrew Taylor, Principle Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02865343     History of Changes
Other Study ID Numbers: SpauldingRH
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Keywords provided by J. Andrew Taylor, Spaulding Rehabilitation Hospital:
Functional Electrical Stimulation (FES)-Rowing

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System