Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
NCT ID: NCT04458324
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2020-12-22
2026-07-31
Brief Summary
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This research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports.
In this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.
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Detailed Description
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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. In addition, pharmacologic treatments may augment respiratory control and improve exercise ventilatory responses. Buspirone can reverse respiratory abnormalities consequent to SCI in rats, and humans case reports suggest successful Buspirone treatment of respiratory dysfunction
Therefore, the investigators propose a double-blind 2x2 trial of 6 months of FESRT with NIV or Sham and Buspirone or Placebo in individuals with acute, high-level SCI. The investigators hypothesize that both NIV and Buspirone will improve ventilatory exercise responses and that combined treatment will have the greatest effect. This will result in greater improvements in aerobic capacity and concomitant increases in pulmonary function and reductions in cardiometabolic risk. This work proposes two approaches to overcome ventilatory limitations to exercise in high level SCI and allow for greater improvements in cardiopulmonary capacity - one that overcomes mechanical limitations of paralyzed pulmonary musculature and one that treats loss of serotonergic respiratory control, both of which may contribute to blunted ventilatory responses. The ultimate purpose of this research is to optimize exercise for a population that both needs and seeks the broad range of benefits that exercise can confer.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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NIV + Buspar
Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar.
Buspirone Hydrochloride
Subjects take 30 mg buspirone HCl twice a day for 6 months.
Noninvasive 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.
Functional Electrical Stimulation Row Training (FESRT)
Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
NIV + placebo
Subjects will perform 6 months of FES-row-training while receiving NIV and taking placebo.
Buspirone placebo
Subjects take a placebo tablet twice a day for 6 months.
Noninvasive 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.
Functional Electrical Stimulation Row Training (FESRT)
Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
sham NIV + Buspar
Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking Buspar.
Buspirone Hydrochloride
Subjects take 30 mg buspirone HCl twice a day for 6 months.
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.
Functional Electrical Stimulation Row Training (FESRT)
Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
sham NIV + placebo
Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking placebo.
Buspirone placebo
Subjects take a placebo tablet twice a day for 6 months.
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.
Functional Electrical Stimulation Row Training (FESRT)
Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
Interventions
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Buspirone Hydrochloride
Subjects take 30 mg buspirone HCl twice a day for 6 months.
Buspirone placebo
Subjects take a placebo tablet twice a day for 6 months.
Noninvasive 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.
Functional Electrical Stimulation Row Training (FESRT)
Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* medically stable
* body mass index 18.5-30 kg/m2 to include normal to overweight but not obese individuals
* 3-months to 6-years post-injury
* ASIA Scale A, B, or C injury at or above neurological level T4
* able to follow directions
* wheelchair users
* leg muscles responsive to stimulation
Exclusion Criteria
* current tobacco users
* significant arrhythmias
* coronary disease
* diabetes
* renal disease
* cancer
* epilepsy
* current use of cardioactive medications (except medication to support blood pressure)
* current grade 2 or greater pressure ulcers at relevant contact sites
* other neurological disease
* peripheral nerve compressions or rotator cuff tears that limit the ability to row
* history of bleeding disorders
* current use of buspirone
* pregnancy
* contraindications to Buspirone (taking MAO inhibitors, known hypersensitivity to buspirone, benzodiazepine dependence, akathisia, renal impairment, hepatic disease)
18 Years
40 Years
ALL
No
Sponsors
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Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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J. Andrew Taylor
Director, Cardiovascular Research Lab
Locations
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Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020P001363
Identifier Type: -
Identifier Source: org_study_id
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