<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810963</url>
  </required_header>
  <id_info>
    <org_study_id>WilliamCareyU</org_study_id>
    <nct_id>NCT03810963</nct_id>
  </id_info>
  <brief_title>FES Cycling and Nutritional Counseling for Battling Obesity After SCI</brief_title>
  <official_title>Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Carey University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Mississippi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>William Carey University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals who suffer from paralysis after spinal cord injury (SCI) are estimated to have an&#xD;
      even greater (66%) prevalence of obesity. Obesity is a major public health concern and is&#xD;
      associated with a plethora of cardiometabolic health complications (heart disease, stroke and&#xD;
      type II diabetes mellitus). Although the benefits of physical activity to counteract obesity&#xD;
      and cardiometabolic disease have been documented, SCI typically limits voluntary exercise to&#xD;
      the often injured arms (60-90%). On the other hand, functional electrical stimulation (FES)&#xD;
      cycling has proven to be a safe and effective way to exercise paralyzed leg muscles in&#xD;
      clinical and home settings, saving the often overworked arms. The investigators have&#xD;
      developed a novel high-intensity interval training (HIIT) protocol for FES lower extremities&#xD;
      cycling that may provide equal or greater benefits with less time commitment. The&#xD;
      investigators proof-of-principle study in 3 obese persons with SCI confirmed that HIIT-FES&#xD;
      cycling 3 times per week for 8 weeks without dietary monitoring can increase legs lean mass&#xD;
      (5-9%), increase cardiovascular health markers (58% on average) and decrease HbA1c blood&#xD;
      levels (2-4%). Also, 2 persons decreased body weight and BMI. The investigators hypothesize&#xD;
      that combining HIIT-FES cycling with nutritional counseling will be effective for reducing&#xD;
      obesity and enhancing cardiometabolic health in persons with chronic SCI. Research AIM: To&#xD;
      determine preliminary efficacy of HIIT-FES cycling combined with nutritional counseling in&#xD;
      obese adults with SCI. In this pilot two-arm, parallel, pre-post, subject-matched controlled&#xD;
      trial, we will test the hypothesis that the experimental group receiving HIIT-FES cycling&#xD;
      plus nutritional counseling will decrease total body weight, decrease body fat percentage,&#xD;
      decrease fat mass, increase total and legs lean mass, improve blood lipid levels, decrease&#xD;
      blood glucose and HbA1c levels and improve vascular endothelial health (flow mediated&#xD;
      dilation) significantly more than age-, sex- and injury-matched controls receiving&#xD;
      nutritional counseling only. The investigators will recruit 20 obese adults, 21-65 years of&#xD;
      age, with chronic post-traumatic SCI ranging in neurological level between C4 and T12.&#xD;
      Participants will be divided into experimental (HIIT-FES cycling plus nutritional counseling)&#xD;
      and control (nutritional counseling only) groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity prevalence among individuals with SCI is about 66%. However, when the BMI formula is&#xD;
      adjusted for the loss of muscle after SCI, the combined overweight and obesity rate is 70 to&#xD;
      75%. This places the SCI population across the U.S. at the top of the list in terms of&#xD;
      obesity. Additionally, because greater obesity is related to greater disability and chronic&#xD;
      diseases, the risk of cardiometabolic diseases, including heart disease, stroke and type II&#xD;
      diabetes, are elevated to more than twice that of the able-bodied population. One reason for&#xD;
      high obesity after SCI is the loss of muscle mass. Shortly after injury, those with SCI&#xD;
      experience rapid and significant skeletal muscle atrophy below the level of injury resulting&#xD;
      in skeletal muscle cross-sectional areas of 45-80% less than that of able-bodied individuals.&#xD;
      Therefore, after SCI, the loss of metabolically active muscle mass results in a 26% reduction&#xD;
      in basal metabolic rate and resting energy expenditure. This is important because basal&#xD;
      metabolic rate accounts for ~65% of the total daily energy expenditure after SCI. In addition&#xD;
      to decreased muscle mass, individuals with SCI are typically among the most sedentary, thus&#xD;
      further lowering energy expenditure creating an unhealthy energy balance.&#xD;
&#xD;
      The benefits of physical activity for reducing obesity and cardiometabolic disease have been&#xD;
      well documented. In particular, high-intensity interval training (HIIT) has been shown to&#xD;
      decrease cardiovascular and metabolic risk among able-bodied individuals in a shorter period&#xD;
      of time than standard non-interval exercise programs. For example, one comparison of interval&#xD;
      walking to continuous walking in able-bodied adults with type II diabetes over a 6-month&#xD;
      period. The continuous walking group walked for 60 minutes 5 days per week at a moderate&#xD;
      intensity while the interval training group alternated between 3 minutes of high intensity&#xD;
      walking and 3 minutes of low intensity walking 5 days per week. The walking intensities were&#xD;
      determined by oxygen uptake (VO2) peak testing and energy expenditure, with moderate&#xD;
      intensity being set at 55% and high intensity at 70% of VO2 peak. Although, the mileage was&#xD;
      the same for both groups, the interval training group lost 4.3 ± 1.2 kg total body weight and&#xD;
      3.1 ± 0.7 kg body fat mass, whereas no changes in body composition were found in the&#xD;
      continuous walking group or the non-walking control group. In a similar study, another&#xD;
      researcher used leg cycling 3 times per week for 12 weeks in both the continuous and interval&#xD;
      groups and determined intensity levels based on heart rate. The interval training group&#xD;
      performed 3 &quot;all out&quot; cycling sessions of 20 seconds each separated by 2 minutes low&#xD;
      intensity cycling, while the continuous group cycled steady at 70% of maximal heart rate for&#xD;
      45 minutes. Both groups improved similarly in insulin sensitivity, cardiorespiratory fitness,&#xD;
      and skeletal muscle mitochondrial content, however, the interval training group achieved&#xD;
      these benefits with a five-fold lower exercise volume and training time commitment.&#xD;
&#xD;
      A major consequence of SCI is that paralysis makes voluntary exercise with the legs&#xD;
      impossible. In addition, the 60-90% prevalence of shoulder pain in persons with chronic SCI&#xD;
      is often limiting the possibility of regular arm exercise. To circumvent these problems, FES&#xD;
      has been shown to be a safe and effective way to exercise paralyzed leg muscles in clinical&#xD;
      and home settings. High-cadence moderate-resistance FES cycling can increase muscle mass and&#xD;
      improve fasting blood glucose values and low-cadence higher-resistance FES cycling can lead&#xD;
      to hypertrophy of the paralyzed leg muscles. As a result of developing our new protocol,&#xD;
      which incorporates resistance-guided high-intensity interval training into FES cycling&#xD;
      (RG-HIIT-FES), we postulate that it may provide equal or greater benefits with less exercise&#xD;
      time commitment, by analogy to high-intensity interval training programs used by able-bodied&#xD;
      individuals. The advantage of using resistance as the determinant of exercise intensity is&#xD;
      the fact that heart rate is an ineffective method for monitoring exercise intensity after&#xD;
      SCI. Instead, we first determine the greatest resistance that stimulated muscles can work&#xD;
      against while cycling at 35 rpm for 30 seconds, use 80% of that maximal resistance for the&#xD;
      high-intensity cycling interval (30 seconds), and then decrease it to 0.5 Nm, which is the&#xD;
      lowest resistance provided by the FES bike (RT300) for the low-intensity cycling interval (30&#xD;
      seconds). These intervals are then alternated for 30 minutes. In a proof-of-principle case&#xD;
      series study using this RG-HIIT-FES cycling protocol 3 times per week for 8 weeks, 3 obese&#xD;
      individuals with SCI increased legs lean mass (5-9%), improved vascular endothelial health&#xD;
      (mean increase of 58% in arterial flow mediated dilation), and decreased HbA1c blood levels&#xD;
      (2-4%). Two of the three participants decreased body weight and BMI.&#xD;
&#xD;
      It is important for proper interpretation of results not to overlook the significance of&#xD;
      nutritional counseling concerning energy intake because food intake can have a major effect&#xD;
      on body composition and health. Individuals with SCI are especially in need of nutritional&#xD;
      counseling due to decreased energy expenditure from reduced metabolic muscle and decreased&#xD;
      activity levels. Consequently, our central hypothesis is that a combined program of&#xD;
      RG-HIIT-FES cycling and nutritional counseling will be effective in combating obesity and&#xD;
      enhancing cardiometabolic health for those with SCI. Specifically, decrease total body weight&#xD;
      and percent body fat, increase total and legs lean mass, improve blood lipid levels, decrease&#xD;
      blood glucose and HbA1c levels and improve cardiovascular health markers (arterial flow&#xD;
      mediated dilation) beyond that observed in the control group that will receive nutritional&#xD;
      counseling alone. The intervention group will receive three 30-minute RG-HIIT-FES cycling&#xD;
      sessions and one 30-minute nutritional counseling session per week for 8 weeks, whereas the&#xD;
      control group will receive one 30-minute nutritional counseling session per week for 8 weeks.&#xD;
&#xD;
      Innovation: The proposed pilot study provides at least three important innovations: 1) the&#xD;
      first formal implementation of a novel and promising FES cycling protocol (RG-HIIT-FES); 2)&#xD;
      the first testing of potential benefits of combining FES cycling with nutritional counseling&#xD;
      in any population; 3) enrollment of a medically underserved and disadvantaged population with&#xD;
      limited options for battling obesity and maintaining cardiovascular health.&#xD;
&#xD;
      Planned Experimental Protocols: The hypothesis for our research aim is that combining&#xD;
      RG-HIIT-FES cycling with nutritional counseling will be more effective than nutritional&#xD;
      counseling alone for reducing obesity and enhancing cardiometabolic health markers in persons&#xD;
      with chronic SCI. This will be tested using a subject-matched controlled pre-post design.&#xD;
      Prior to and after the 8 weeks of experimental or control intervention, each participant will&#xD;
      visit the SCI Research Laboratory during the morning hours (between 7:00 and 10:00 am),&#xD;
      following an overnight fast and having refrained from caffeine and alcohol intake for 12 and&#xD;
      24 hours, respectively. After reviewing and signing the informed consent and medical history&#xD;
      documents, participants will be weighed using a Scale-Tronix Wheelchair Scale (Welch Allyn,&#xD;
      Skaneatelest Falls, NY). The weight of the wheelchair alone subtracted from the combined&#xD;
      weight of the participant and wheelchair will provide the weight of the participant. An&#xD;
      electric powered lift (Invacare, Reliant 450) will be used to provide safe transfers for all&#xD;
      participants from the participant's wheelchair to various testing locations (e.g., exam table&#xD;
      and DXA body composition scanner). Once on the exam table in a supine position, an&#xD;
      anthropometric measuring rod will be used to measure height. The left leg will be extended&#xD;
      and ankle dorsiflexed to enable an accurate measurement from the bottom of foot to top of the&#xD;
      head. Following 20 minutes of quiet rest in a dimly lit and temperature (21-23°C, 50%&#xD;
      humidity) controlled room, 5 minutes of resting hemodynamic data (hear rate and blood&#xD;
      pressure) will be recorded followed by Doppler ultrasound vascular endothelial function&#xD;
      testing, followed shortly after by a finger stick on the left hand for determination of blood&#xD;
      lipid, glucose and HbA1c levels. The participants will then be transferred back to their&#xD;
      wheelchair and taken to an adjacent laboratory in the same building for DXA scanning.&#xD;
      Following the DXA scan, participants return to the SCI Research lab and complete a resistance&#xD;
      guided FES cycle maximal test from there own wheelchairs in order to gain baseline parameters&#xD;
      for the RG-HIIT-FES cycling protocol, and also to determine each participants ability to&#xD;
      tolerate and safely perform the cycling program. Participants in the&#xD;
      experimental/intervention group will then complete FES cycling as described above for 30&#xD;
      minutes, 3 times per week for 8 weeks and will receive nutritional counseling over the&#xD;
      telephone for 30 minutes 1 time per week for 8 weeks. Then post-testing will occur in the&#xD;
      same fashion as the pre-testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Fat Percentage</measure>
    <time_frame>Eight Weeks</time_frame>
    <description>Percentage of body fat measured during pre- and post-testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat mass and lean mass</measure>
    <time_frame>Eight Weeks</time_frame>
    <description>Total fat and lean mass in kg measured during pre- and post-testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial health via flow mediated dilation</measure>
    <time_frame>Eight Weeks</time_frame>
    <description>Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood glucose testing</measure>
    <time_frame>8 weeks</time_frame>
    <description>Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre- post- intervention three day dietary recall</measure>
    <time_frame>Eight Weeks</time_frame>
    <description>Prior to and after the intervention a 3 day dietary recall will be completed to determine changes in dietary habits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>FES Cycling and Nutrition Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device:&#xD;
HIIT-FES cycling will be performed 30 minutes per session, 3 times per week for 3 weeks combined with&#xD;
Behavior:&#xD;
Nutrition counseling will be completed via telephone for 30 minutes once per week for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Counseling Only</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Behavior:&#xD;
Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>HIIT-FES Cycling combined with Nutritional Counseling</intervention_name>
    <description>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.</description>
    <arm_group_label>FES Cycling and Nutrition Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional Counseling Only</intervention_name>
    <description>Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.</description>
    <arm_group_label>Nutritional Counseling Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  We will recruit men and women with C4-T12 SCI (n=20) American Spinal Injury&#xD;
             Association Impairment Scale A, B, or C as per International Standards for&#xD;
             Neurological Classification of SCI; ≥2 years post-SCI; age 21-65 years; body fat&#xD;
             percentage according to over-weight classifications detailed in Gallagher et al. Am J&#xD;
             Clin Nut 2000,72:694-701 ( women 20-40 y/o &gt; 30%, 41-60 y/o &gt; 35%, &gt; 60 y/o &gt; 42%; men&#xD;
             20-40 y/o &gt; 19%, 40-60 y/o &gt; 22%, &gt; 60 y/o &gt; 25%).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include pressure wounds on buttocks or feet; unhealed bone&#xD;
             fractures or history of fragility fractures; uncontrolled cardiovascular or metabolic&#xD;
             disease; severe osteoporosis (T score ≤ 4); uncontrolled autonomic dysreflexia; and&#xD;
             current smokers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Dolbow, DPT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Carey University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Carey University Physical Therapy Program</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Carey University</investigator_affiliation>
    <investigator_full_name>David Dolbow</investigator_full_name>
    <investigator_title>Associate Professor of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>High intensity interval training</keyword>
  <keyword>functional electrical stimulation cycling</keyword>
  <keyword>chronic spinal cord injury</keyword>
  <keyword>cardiometabolic disease risk</keyword>
  <keyword>body composition</keyword>
  <keyword>body fat percentage</keyword>
  <keyword>nutritional counseling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>None currently</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810963
org study id: WilliamCareyU
nct id: NCT03810963
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Body Fat Percentage
time frame: Eight Weeks
description: Percentage of body fat measured during pre- and post-testing
measure: Fat mass and lean mass
time frame: Eight Weeks
description: Total fat and lean mass in kg measured during pre- and post-testing
measure: Arterial health via flow mediated dilation
time frame: Eight Weeks
description: Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing
measure: Blood glucose testing
time frame: 8 weeks
description: Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures
measure: Pre- post- intervention three day dietary recall
time frame: Eight Weeks
description: Prior to and after the intervention a 3 day dietary recall will be completed to determine changes in dietary habits.
arm group label: FES Cycling and Nutrition Counseling
arm group type: Experimental
description: Device:
HIIT-FES cycling will be performed 30 minutes per session, 3 times per week for 3 weeks combined with
Behavior:
Nutrition counseling will be completed via telephone for 30 minutes once per week for 8 weeks.
arm group label: Nutritional Counseling Only
arm group type: Other
description: Behavior:
Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks.
intervention type: Combination Product
intervention name: HIIT-FES Cycling combined with Nutritional Counseling
description: 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.
arm group label: FES Cycling and Nutrition Counseling
intervention type: Other
intervention name: Nutritional Counseling Only
description: Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
arm group label: Nutritional Counseling Only
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Dolbow, DPT, PhD
role: Principal Investigator
affiliation: William Carey University
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: William Carey University
investigator full name: David Dolbow
investigator title: Associate Professor of Physical Therapy
mesh term: Spinal Cord Injuries
sharing ipd: No
ipd description: None currently