Ventilatory Support to Improve Exercise Training in High Level Spinal Cord Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/23/2019 |
| Start Date: | February 22, 2017 |
| End Date: | July 2019 |
| Contact: | Isabelle Vivodtzev, PhD |
| Email: | IVivodtzev@partners.org |
| Phone: | 6177585504 |
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.
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.
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.
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.
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
We found this trial at
1
site
Cambridge, Massachusetts 02138
Principal Investigator: J. Andrew Taylor, Ph.D.
Phone: 617-758-5511
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