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Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury

Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02865343
Acronym
NIV-Ex
Enrollment
11
Registered
2016-08-12
Start date
2017-02-22
Completion date
2019-06-28
Last updated
2023-02-09

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

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 3 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.

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 3 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 3 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.

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.

Sponsors

Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
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 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Baseline Aerobic Capacity After 3 Months of FES-row Training.Baseline and 3 monthsVolunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition

Secondary

MeasureTime frameDescription
Change in Peak Cardiac Output After 3 Months of FES-row Training.Baseline and 3 monthsVolunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition
Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row TrainingBaseline and 3 monthsVolunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
6
Sham Non-invasive Ventilation(NIV)
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.
5
Total11

Baseline characteristics

CharacteristicNon-invasive Ventilation(NIV)Sham Non-invasive Ventilation(NIV)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants5 Participants11 Participants
Age, Continuous43 years
STANDARD_DEVIATION 15
31 years
STANDARD_DEVIATION 8
39 years
STANDARD_DEVIATION 14
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants4 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants5 Participants11 Participants
Region of Enrollment
United States
6 Participants5 Participants11 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
6 Participants5 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 5
other
Total, other adverse events
0 / 60 / 5
serious
Total, serious adverse events
0 / 60 / 5

Outcome results

Primary

Change in Baseline Aerobic Capacity After 3 Months of FES-row Training.

Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition

Time frame: Baseline and 3 months

Population: Only participants who reached the criteria of maximality during the maximal incremental test

ArmMeasureValue (MEAN)Dispersion
Non-invasive Ventilation(NIV)Change in Baseline Aerobic Capacity After 3 Months of FES-row Training.0.21 L/minStandard Deviation 0.04
Sham Non-invasive Ventilation(NIV)Change in Baseline Aerobic Capacity After 3 Months of FES-row Training.0.08 L/minStandard Deviation 0.1
Secondary

Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training

Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition

Time frame: Baseline and 3 months

Population: Only individuals who reached maximality during the maximal incremental test

ArmMeasureValue (MEAN)Dispersion
Non-invasive Ventilation(NIV)Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training1.4 L/minStandard Deviation 2.1
Sham Non-invasive Ventilation(NIV)Change in Baseline Peak Minute Ventilation During Exercise After 3 Months of FES-row Training3.1 L/minStandard Deviation 1.6
Secondary

Change in Peak Cardiac Output After 3 Months of FES-row Training.

Volunteers will perform a maximal incremental FES-row tests. Both NIV Support and Sham-NIV groups will perform tests in the Sham-NIV condition

Time frame: Baseline and 3 months

Population: only individuals who sustained exercise while measuring CO

ArmMeasureValue (MEAN)Dispersion
Non-invasive Ventilation(NIV)Change in Peak Cardiac Output After 3 Months of FES-row Training.2.8 L/minStandard Deviation 0
Sham Non-invasive Ventilation(NIV)Change in Peak Cardiac Output After 3 Months of FES-row Training.-2.2 L/minStandard Deviation 1.8

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