Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorWilliam Carey University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

pressure wounds on buttocks or feet

unhealed bone fractures or history of fragility fractures

uncontrolled cardiovascular disease

uncontrolled Type-2 diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Muscle strengthening exercise followed by Hybrid FES cycling Exercise

    Other intervention

    Resistance exercise with arms and electrical stimulation to legs (4 sets of 10 repetitions twice weekly for 4 weeks followed by Hybrid FES cycling which is functional electrical stimulation cycling with the legs and voluntary cycling with the arms for 20-30 minutes twice weekly for 8 weeks.

  • Active ROM exercise with arms and Passive ROM exercise with legs

    Other intervention

    Active ROM exercise with arms and Passive ROM exercise with legs both 4 sets of 10 repetitions twice weekly

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Muscle strengthening exercise and hybrid FES cyclingExperimental treatment 2 interventions
Group B: Active range of motion exercise with the arms 4x10 reps and passive range of motion to legs 4x10.Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Aerobic Fitness

Vo2peak determined by arm crank maximal exercise stress test

Time frame
12 weeks
2

Percent body fat

Percent body fat determined by DXA scan.

Time frame
12 weeks
3

Percent lean mass

Percent and amount of lean mass (muscle and bone) determined by DXA scan.

Time frame
12 weeks
4

Lipid profile

Blood testing of high density lipoprotein

Time frame
12 weeks

Secondary outcomes

Other outcomes

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