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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Sham Non-invasive ventilation(NIV); Device: Non-invasive ventilation(NIV); Other: Functional Electrical Stimulation Row Training (FESRT)

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Spaulding Hospital Cambridge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peak Aerobic Capacity During FES-row Testing	Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV	Day 0 and Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Output During FES-row Testing	Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV	Day 0 and Day 2
Change in Minute Ventilation During FES-row Testing	Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV	Day 0 and Day 2
Change in Tidal Volume During FES-row Testing	Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV	Day 0 and Day 2

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Publications and helpful links

General Publications

• Vivodtzev I, Picard G, Cepeda FX, Taylor JA. Acute Ventilatory Support During Whole-Body Hybrid Rowing in Patients With High-Level Spinal Cord Injury: A Randomized Controlled Crossover Trial. Chest. 2020 May;157(5):1230-1240. doi: 10.1016/j.chest.2019.10.044. Epub 2019 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Functional Electrical Stimulation (FES)-Rowing; Ventilatory support
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: SpauldingRH-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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