FES Cycling and Nutritional Counseling for Battling Obesity After SCI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03810963|
Recruitment Status : Completed
First Posted : January 21, 2019
Last Update Posted : October 4, 2019
|First Submitted Date ICMJE||January 15, 2019|
|First Posted Date ICMJE||January 21, 2019|
|Last Update Posted Date||October 4, 2019|
|Actual Study Start Date ICMJE||May 1, 2017|
|Actual Primary Completion Date||May 1, 2019 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03810963 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||FES Cycling and Nutritional Counseling for Battling Obesity After SCI|
|Official Title ICMJE||Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI|
|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.|
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||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
|Condition ICMJE||Spinal Cord Injuries|
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||May 1, 2019|
|Actual Primary Completion Date||May 1, 2019 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||21 Years to 65 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT03810963|
|Other Study ID Numbers ICMJE||WilliamCareyU|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||David Dolbow, William Carey University|
|Study Sponsor ICMJE||William Carey University|
|PRS Account||William Carey University|
|Verification Date||October 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP