FES Cycling and Nutritional Counseling for Battling Obesity After SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Individuals who suffer from paralysis after spinal cord injury (SCI) are estimated to have an
      even greater (66%) prevalence of obesity. Obesity is a major public health concern and is
      associated with a plethora of cardiometabolic health complications (heart disease, stroke and
      type II diabetes mellitus). Although the benefits of physical activity to counteract obesity
      and cardiometabolic disease have been documented, SCI typically limits voluntary exercise to
      the often injured arms (60-90%). On the other hand, functional electrical stimulation (FES)
      cycling has proven to be a safe and effective way to exercise paralyzed leg muscles in
      clinical and home settings, saving the often overworked arms. The investigators have
      developed a novel high-intensity interval training (HIIT) protocol for FES lower extremities
      cycling that may provide equal or greater benefits with less time commitment. The
      investigators proof-of-principle study in 3 obese persons with SCI confirmed that HIIT-FES
      cycling 3 times per week for 8 weeks without dietary monitoring can increase legs lean mass
      (5-9%), increase cardiovascular health markers (58% on average) and decrease HbA1c blood
      levels (2-4%). Also, 2 persons decreased body weight and BMI. The investigators hypothesize
      that combining HIIT-FES cycling with nutritional counseling will be effective for reducing
      obesity and enhancing cardiometabolic health in persons with chronic SCI. Research AIM: To
      determine preliminary efficacy of HIIT-FES cycling combined with nutritional counseling in
      obese adults with SCI. In this pilot two-arm, parallel, pre-post, subject-matched controlled
      trial, we will test the hypothesis that the experimental group receiving HIIT-FES cycling
      plus nutritional counseling will decrease total body weight, decrease body fat percentage,
      decrease fat mass, increase total and legs lean mass, improve blood lipid levels, decrease
      blood glucose and HbA1c levels and improve vascular endothelial health (flow mediated
      dilation) significantly more than age-, sex- and injury-matched controls receiving
      nutritional counseling only. The investigators will recruit 20 obese adults, 21-65 years of
      age, with chronic post-traumatic SCI ranging in neurological level between C4 and T12.
      Participants will be divided into experimental (HIIT-FES cycling plus nutritional counseling)
      and control (nutritional counseling only) groups.
    

Detailed description: 
      Obesity prevalence among individuals with SCI is about 66%. However, when the BMI formula is
      adjusted for the loss of muscle after SCI, the combined overweight and obesity rate is 70 to
      75%. This places the SCI population across the U.S. at the top of the list in terms of
      obesity. Additionally, because greater obesity is related to greater disability and chronic
      diseases, the risk of cardiometabolic diseases, including heart disease, stroke and type II
      diabetes, are elevated to more than twice that of the able-bodied population. One reason for
      high obesity after SCI is the loss of muscle mass. Shortly after injury, those with SCI
      experience rapid and significant skeletal muscle atrophy below the level of injury resulting
      in skeletal muscle cross-sectional areas of 45-80% less than that of able-bodied individuals.
      Therefore, after SCI, the loss of metabolically active muscle mass results in a 26% reduction
      in basal metabolic rate and resting energy expenditure. This is important because basal
      metabolic rate accounts for ~65% of the total daily energy expenditure after SCI. In addition
      to decreased muscle mass, individuals with SCI are typically among the most sedentary, thus
      further lowering energy expenditure creating an unhealthy energy balance.

      The benefits of physical activity for reducing obesity and cardiometabolic disease have been
      well documented. In particular, high-intensity interval training (HIIT) has been shown to
      decrease cardiovascular and metabolic risk among able-bodied individuals in a shorter period
      of time than standard non-interval exercise programs. For example, one comparison of interval
      walking to continuous walking in able-bodied adults with type II diabetes over a 6-month
      period. The continuous walking group walked for 60 minutes 5 days per week at a moderate
      intensity while the interval training group alternated between 3 minutes of high intensity
      walking and 3 minutes of low intensity walking 5 days per week. The walking intensities were
      determined by oxygen uptake (VO2) peak testing and energy expenditure, with moderate
      intensity being set at 55% and high intensity at 70% of VO2 peak. Although, the mileage was
      the same for both groups, the interval training group lost 4.3 ± 1.2 kg total body weight and
      3.1 ± 0.7 kg body fat mass, whereas no changes in body composition were found in the
      continuous walking group or the non-walking control group. In a similar study, another
      researcher used leg cycling 3 times per week for 12 weeks in both the continuous and interval
      groups and determined intensity levels based on heart rate. The interval training group
      performed 3 "all out" cycling sessions of 20 seconds each separated by 2 minutes low
      intensity cycling, while the continuous group cycled steady at 70% of maximal heart rate for
      45 minutes. Both groups improved similarly in insulin sensitivity, cardiorespiratory fitness,
      and skeletal muscle mitochondrial content, however, the interval training group achieved
      these benefits with a five-fold lower exercise volume and training time commitment.

      A major consequence of SCI is that paralysis makes voluntary exercise with the legs
      impossible. In addition, the 60-90% prevalence of shoulder pain in persons with chronic SCI
      is often limiting the possibility of regular arm exercise. To circumvent these problems, FES
      has been shown to be a safe and effective way to exercise paralyzed leg muscles in clinical
      and home settings. High-cadence moderate-resistance FES cycling can increase muscle mass and
      improve fasting blood glucose values and low-cadence higher-resistance FES cycling can lead
      to hypertrophy of the paralyzed leg muscles. As a result of developing our new protocol,
      which incorporates resistance-guided high-intensity interval training into FES cycling
      (RG-HIIT-FES), we postulate that it may provide equal or greater benefits with less exercise
      time commitment, by analogy to high-intensity interval training programs used by able-bodied
      individuals. The advantage of using resistance as the determinant of exercise intensity is
      the fact that heart rate is an ineffective method for monitoring exercise intensity after
      SCI. Instead, we first determine the greatest resistance that stimulated muscles can work
      against while cycling at 35 rpm for 30 seconds, use 80% of that maximal resistance for the
      high-intensity cycling interval (30 seconds), and then decrease it to 0.5 Nm, which is the
      lowest resistance provided by the FES bike (RT300) for the low-intensity cycling interval (30
      seconds). These intervals are then alternated for 30 minutes. In a proof-of-principle case
      series study using this RG-HIIT-FES cycling protocol 3 times per week for 8 weeks, 3 obese
      individuals with SCI increased legs lean mass (5-9%), improved vascular endothelial health
      (mean increase of 58% in arterial flow mediated dilation), and decreased HbA1c blood levels
      (2-4%). Two of the three participants decreased body weight and BMI.

      It is important for proper interpretation of results not to overlook the significance of
      nutritional counseling concerning energy intake because food intake can have a major effect
      on body composition and health. Individuals with SCI are especially in need of nutritional
      counseling due to decreased energy expenditure from reduced metabolic muscle and decreased
      activity levels. Consequently, our central hypothesis is that a combined program of
      RG-HIIT-FES cycling and nutritional counseling will be effective in combating obesity and
      enhancing cardiometabolic health for those with SCI. Specifically, decrease total body weight
      and percent body fat, increase total and legs lean mass, improve blood lipid levels, decrease
      blood glucose and HbA1c levels and improve cardiovascular health markers (arterial flow
      mediated dilation) beyond that observed in the control group that will receive nutritional
      counseling alone. The intervention group will receive three 30-minute RG-HIIT-FES cycling
      sessions and one 30-minute nutritional counseling session per week for 8 weeks, whereas the
      control group will receive one 30-minute nutritional counseling session per week for 8 weeks.

      Innovation: The proposed pilot study provides at least three important innovations: 1) the
      first formal implementation of a novel and promising FES cycling protocol (RG-HIIT-FES); 2)
      the first testing of potential benefits of combining FES cycling with nutritional counseling
      in any population; 3) enrollment of a medically underserved and disadvantaged population with
      limited options for battling obesity and maintaining cardiovascular health.

      Planned Experimental Protocols: The hypothesis for our research aim is that combining
      RG-HIIT-FES cycling with nutritional counseling will be more effective than nutritional
      counseling alone for reducing obesity and enhancing cardiometabolic health markers in persons
      with chronic SCI. This will be tested using a subject-matched controlled pre-post design.
      Prior to and after the 8 weeks of experimental or control intervention, each participant will
      visit the SCI Research Laboratory during the morning hours (between 7:00 and 10:00 am),
      following an overnight fast and having refrained from caffeine and alcohol intake for 12 and
      24 hours, respectively. After reviewing and signing the informed consent and medical history
      documents, participants will be weighed using a Scale-Tronix Wheelchair Scale (Welch Allyn,
      Skaneatelest Falls, NY). The weight of the wheelchair alone subtracted from the combined
      weight of the participant and wheelchair will provide the weight of the participant. An
      electric powered lift (Invacare, Reliant 450) will be used to provide safe transfers for all
      participants from the participant's wheelchair to various testing locations (e.g., exam table
      and DXA body composition scanner). Once on the exam table in a supine position, an
      anthropometric measuring rod will be used to measure height. The left leg will be extended
      and ankle dorsiflexed to enable an accurate measurement from the bottom of foot to top of the
      head. Following 20 minutes of quiet rest in a dimly lit and temperature (21-23°C, 50%
      humidity) controlled room, 5 minutes of resting hemodynamic data (hear rate and blood
      pressure) will be recorded followed by Doppler ultrasound vascular endothelial function
      testing, followed shortly after by a finger stick on the left hand for determination of blood
      lipid, glucose and HbA1c levels. The participants will then be transferred back to their
      wheelchair and taken to an adjacent laboratory in the same building for DXA scanning.
      Following the DXA scan, participants return to the SCI Research lab and complete a resistance
      guided FES cycle maximal test from there own wheelchairs in order to gain baseline parameters
      for the RG-HIIT-FES cycling protocol, and also to determine each participants ability to
      tolerate and safely perform the cycling program. Participants in the
      experimental/intervention group will then complete FES cycling as described above for 30
      minutes, 3 times per week for 8 weeks and will receive nutritional counseling over the
      telephone for 30 minutes 1 time per week for 8 weeks. Then post-testing will occur in the
      same fashion as the pre-testing.
    

Intervention name(s): HIIT-FES Cycling combined with Nutritional Counseling; Nutritional Counseling Only
Intervention type(s): Combination Product; Other
Intervention description(s): High intensity interval training functional electrical stimulation cycling for 30 minutes, three days per week for eight weeks, Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.; Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The hypothesis for our research aim is that combining RG-HIIT-FES cycling with nutritional counseling will be more effective than nutritional counseling alone for reducing obesity and enhancing cardiometabolic health markers in persons with chronic SCI. This will be tested using a subject-matched controlled pre-post design. The experimental group receives 30 minutes of RG-HIIT-FES cycling three times per week for eight weeks and nutritional counseling over the telephone for 30 minutes one time per week for eight weeks. The control group receives the nutritional counseling only.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High intensity interval training; functional electrical stimulation cycling; chronic spinal cord injury; cardiometabolic disease risk; body composition; body fat percentage; nutritional counseling