Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health
Recruiting
N/AInterventional Study
Spinal Cord Injuries
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 – 70
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
12 (estimated)
Sponsor
William Carey University · Other
Who this trial is looking for
This trial is looking for men and women aged 21 to 70 with spinal cord injuries. Participants will engage in a cycling program that aims to improve health and physical fitness.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 21 and 70 years old
I have a spinal cord injury from C4 to T12
I have had my spinal cord injury for at least 1 year
I can do voluntary arm cycling
You may not be able to join if
I have pressure wounds on my buttocks or feet
I have unhealed bone fractures or past fragility fractures
I have uncontrolled cardiovascular disease
I have uncontrolled Type-2 diabetes
I have severe osteoporosis
I have uncontrolled autonomic dysreflexia
I have orthopedic problems that prevent leg and arm cycling
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an obesity rate of over 90% and a metabolic syndrome rate of 60%. These results are significantly higher…
Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an obesity rate of over 90% and a metabolic syndrome rate of 60%. These results are significantly higher than in the general population. As such individuals with SCI typically have systemic inflammation and an accelerated trajectory towards cardiometabolic disease, and early mortality. Although the accelerated trajectory is multi-factorial, substantial evidence implicates sedentary behavior and low physical activity levels as significant contributing factors. Exercise strategies for individuals with SCI have included upper body arm crank exercise (ACE), functional electrical stimulation leg cycling exercise (FES-LCE), or a combination of the two (FES Hybrid Exercise). These modalities have yielded modest improvements in physical fitness and cardiometabolic risk profiles in individuals with SCI. FES-LCE reportedly increased lean-to-fat mass ratio, enhanced peripheral blood flow and vasoreactivity, and increased bone mass in the paralyzed legs. In addition, FES-LCE improves metabolic function as evidenced by increased glucose disposal. There is evidence that high-intensity interval training exercise can increase muscle mass and improve cardiovascular fitness with considerably less time commitment than non-interval activities. However, given many individuals with SCI respond poorly to the onset of training a primer exercise program for the extremely deconditioned muscles is recommended for optimal results. The investigators intend to investigate the optimization of benefits by using a novel hybrid FES cycling protocol (FES legs cycling plus voluntary arms cycling) combined with high intensity interval training (HIIT) and preceded by a preparatory muscle strengthening program called "peripheral remodeling intermittent muscular exercise (PRIME) to prepare the deconditioned muscles for the more intense exercise in the hybrid HIIT-FES cycling program. The investigators hypothesize that individuals in the PRIME + hybrid HIIT-FES cycling program will demonstrate significantly greater cardiometabolic health and functional benefits than the control group receiving standard of care range of motion exercises.
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Eligibility Criteria
Inclusion Criteria:
* men and women ages 21-70 years
* C4-T12 SCI American Spinal Injury Association Impairment Scale A, B, and C as per International Standards for Neurological Classification of SCI
* ≥1 years post-SCI
* Participants must be able to perform voluntary arm cycling.
Exclusion Criter…
Inclusion Criteria:
* men and women ages 21-70 years
* C4-T12 SCI American Spinal Injury Association Impairment Scale A, B, and C as per International Standards for Neurological Classification of SCI
* ≥1 years post-SCI
* Participants must be able to perform voluntary arm cycling.
Exclusion Criteria:
* pressure wounds on buttocks or feet
* unhealed bone fractures or history of fragility fractures
* uncontrolled cardiovascular disease
* uncontrolled Type-2 diabetes
* severe osteoporosis (T score below -4)
* uncontrolled autonomic dysreflexia
* orthopedic or other problems that preclude leg and arm cycling.
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