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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03267212
Recruitment Status : Completed
First Posted : August 30, 2017
Results First Posted : February 17, 2020
Last Update Posted : April 9, 2020
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 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))

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Non-invasive ventilation(NIV) Device: Sham Non-invasive ventilation(NIV) Other: Functional Electrical Stimulation Row Training (FESRT) 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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Official Title: Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Other: Functional Electrical Stimulation Row Training (FESRT)
FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training

Sham Comparator: Sham Non-invasive ventilation(NIV)
Subjects will perform FES-row testing 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.

Other: Functional Electrical Stimulation Row Training (FESRT)
FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training




Primary Outcome Measures :
  1. Change in Peak Aerobic Capacity During FES-row Testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV


Secondary Outcome Measures :
  1. Change in Cardiac Output During FES-row Testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV

  2. Change in Minute Ventilation During FES-row Testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV

  3. Change in Tidal Volume During FES-row Testing [ Time Frame: Day 0 and Day 2 ]
    Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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): NCT03267212


Locations
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United States, Massachusetts
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: J. Andrew Taylor, PhD Spaulding Rehabilitation Hospital
  Study Documents (Full-Text)

Documents provided by J. Andrew Taylor, Spaulding Rehabilitation Hospital:
Informed Consent Form  [PDF] October 17, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: J. Andrew Taylor, Principle Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03267212    
Other Study ID Numbers: SpauldingRH-2
First Posted: August 30, 2017    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: April 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by J. Andrew Taylor, Spaulding Rehabilitation Hospital:
Functional Electrical Stimulation (FES)-Rowing
Ventilatory support
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System