Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— NIV-Ex-CS  

Official title:

Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267212
• Other study ID #: SpauldingRH-2
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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))

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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Spaulding Hospital Cambridge	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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