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FES Cycling and Nutritional Counseling for Battling Obesity After SCI

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ClinicalTrials.gov Identifier: NCT03810963
Recruitment Status : Completed
First Posted : January 21, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
University of Southern Mississippi
University of Mississippi Medical Center
Information provided by (Responsible Party):
David Dolbow, William Carey University

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Combination Product: HIIT-FES Cycling combined with Nutritional Counseling Other: Nutritional Counseling Only Not Applicable

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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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Official Title: Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FES Cycling and Nutrition Counseling

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.

Combination Product: HIIT-FES Cycling combined with Nutritional Counseling
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 Only

Behavior:

Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks.

Other: Nutritional Counseling Only
Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.




Primary Outcome Measures :
  1. Body Fat Percentage [ Time Frame: Eight Weeks ]
    Percentage of body fat measured during pre- and post-testing

  2. Fat mass and lean mass [ Time Frame: Eight Weeks ]
    Total fat and lean mass in kg measured during pre- and post-testing

  3. Arterial health via flow mediated dilation [ Time Frame: Eight Weeks ]
    Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing

  4. Blood glucose testing [ Time Frame: 8 weeks ]
    Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures


Secondary Outcome Measures :
  1. Pre- post- intervention three day dietary recall [ Time Frame: Eight Weeks ]
    Prior to and after the intervention a 3 day dietary recall will be completed to determine changes in dietary habits.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We will recruit men and women with C4-T12 SCI (n=20) American Spinal Injury Association Impairment Scale A, B, or C as per International Standards for Neurological Classification of SCI; ≥2 years post-SCI; age 21-65 years; body fat percentage according to over-weight classifications detailed in Gallagher et al. Am J Clin Nut 2000,72:694-701 ( women 20-40 y/o > 30%, 41-60 y/o > 35%, > 60 y/o > 42%; men 20-40 y/o > 19%, 40-60 y/o > 22%, > 60 y/o > 25%).

Exclusion Criteria:

  • Exclusion criteria include pressure wounds on buttocks or feet; unhealed bone fractures or history of fragility fractures; uncontrolled cardiovascular or metabolic disease; severe osteoporosis (T score ≤ 4); uncontrolled autonomic dysreflexia; and current smokers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810963


Locations
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United States, Mississippi
William Carey University Physical Therapy Program
Hattiesburg, Mississippi, United States, 39401
Sponsors and Collaborators
William Carey University
University of Southern Mississippi
University of Mississippi Medical Center
Investigators
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Principal Investigator: David Dolbow, DPT, PhD William Carey University

Publications of Results:

Other Publications:
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Responsible Party: David Dolbow, Associate Professor of Physical Therapy, William Carey University
ClinicalTrials.gov Identifier: NCT03810963     History of Changes
Other Study ID Numbers: WilliamCareyU
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: None currently

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Dolbow, William Carey University:
High intensity interval training
functional electrical stimulation cycling
chronic spinal cord injury
cardiometabolic disease risk
body composition
body fat percentage
nutritional counseling
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries