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Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03267212
Acronym
NIV-Ex-CS
Enrollment
15
Registered
2017-08-30
Start date
2017-07-14
Completion date
2019-04-01
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Functional Electrical Stimulation (FES)-Rowing, Ventilatory support

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))

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.

Interventions

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.

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.

FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training

Sponsors

Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Peak Aerobic Capacity During FES-row TestingDay 0 and Day 2Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV

Secondary

MeasureTime frameDescription
Change in Cardiac Output During FES-row TestingDay 0 and Day 2Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Change in Minute Ventilation During FES-row TestingDay 0 and Day 2Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV
Change in Tidal Volume During FES-row TestingDay 0 and Day 2Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV

Countries

United States

Participant flow

Participants by arm

ArmCount
Non-invasive Ventilation(NIV) vs. Sham Ventilation
All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation (or Sham ventilation) applied through a full face-mask. The tests were performed in a random order. Non-invasive ventilation(NIV): The ventilator was 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 was 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. Functional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
15
Total15

Withdrawals & dropouts

PeriodReasonFG000FG001
First InterventionLost to Follow-up02
First InterventionWithdrawal by Subject11
Washout (Min 2 Days / Max 7 Days)Physician Decision10

Baseline characteristics

CharacteristicNon-invasive Ventilation(NIV) vs. Sham Ventilation
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
Age, Continuous40 years
Body Mass Index27 Kg/m2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
14 Participants
Region of Enrollment
United States
15 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 10
other
Total, other adverse events
0 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 10

Outcome results

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

Time frame: Day 0 and Day 2

Population: 10 subjects completed both NIV and Sham tests

ArmMeasureValue (MEAN)Dispersion
Non-invasive VentilationChange in Peak Aerobic Capacity During FES-row Testing1.83 L/minStandard Deviation 0.76
Sham VentilationChange in Peak Aerobic Capacity During FES-row Testing1.82 L/minStandard Deviation 0.64
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

Time frame: Day 0 and Day 2

Population: Due to technical issues, only one participant could perform both tests (NIV and sham) for this outcome

ArmMeasureValue (NUMBER)
Non-invasive VentilationChange in Cardiac Output During FES-row Testing9.6 L/min
Sham VentilationChange in Cardiac Output During FES-row Testing10.3 L/min
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

Time frame: Day 0 and Day 2

Population: Participants who completed both NIV and sham tests

ArmMeasureValue (MEAN)Dispersion
Non-invasive VentilationChange in Minute Ventilation During FES-row Testing38.8 L/minStandard Deviation 9.6
Sham VentilationChange in Minute Ventilation During FES-row Testing40.3 L/minStandard Deviation 10
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

Time frame: Day 0 and Day 2

Population: Participants who completed both NIV and sham tests

ArmMeasureValue (MEAN)Dispersion
Non-invasive VentilationChange in Tidal Volume During FES-row Testing1.6 LStandard Error 0.3
Sham VentilationChange in Tidal Volume During FES-row Testing1.4 LStandard Error 0.3

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026