Spinal Cord InjuriesNCT03810963
FES Cycling and Nutritional Counseling for Battling Obesity After SCI
A study testing HIIT-FES Cycling combined with Nutritional Counseling and Nutritional Counseling Only in people with Spinal Cord Injuries, run by William Carey University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- HIIT-FES Cycling combined with Nutritional Counseling and Nutritional Counseling Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Carey University Physical Therapy Program
Hattiesburg, Mississippi, 39401
About this study
Official title: Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- HIIT-FES Cycling combined with Nutritional Counseling, Nutritional Counseling Only
- Keywords
- High intensity interval training, functional electrical stimulation cycling, chronic spinal cord injury, cardiometabolic disease risk, body composition, body fat percentage, nutritional counseling
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT-FES Cycling combined with Nutritional CounselingCombination product
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 OnlyOther
Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| FES Cycling and Nutrition Counseling | Experimental | 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. Receives: Combination Product: HIIT-FES Cycling combined with Nutritional Counseling |
| Nutritional Counseling Only | Other | Behavior:
Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks. Receives: Other: Nutritional Counseling Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat Percentage
Percentage of body fat measured during pre- and post-testing
Measured: Eight Weeks
Fat mass and lean mass
Total fat and lean mass in kg measured during pre- and post-testing
Measured: Eight Weeks
Arterial health via flow mediated dilation
Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing
Measured: Eight Weeks
Blood glucose testing
Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures
Measured: 8 weeks
Secondary outcomes (1)
Pre- post- intervention three day dietary recall
Prior to and after the intervention a 3 day dietary recall will be completed to determine changes in dietary habits.
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 May 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Carey University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Mississippi, University of Mississippi Medical Center
- Responsible party
- Principal investigator, David Dolbow, William Carey University
- Investigators
- David Dolbow, DPT, PhD, Principal investigator, William Carey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810963
- Sponsor's protocol ID
- WilliamCareyU
- Status last verified
- Oct 2019
- First submitted
- 15 Jan 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None currently
Publications
Conway JM, Ingwersen LA, Moshfegh AJ. Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc. 2004 Apr;104(4):595-603. doi: 10.1016/j.jada.2004.01.007.
PubMed 15054345Froehlich-Grobe K, Lee J, Washburn RA. Disparities in obesity and related conditions among Americans with disabilities. Am J Prev Med. 2013 Jul;45(1):83-90. doi: 10.1016/j.amepre.2013.02.021.
PubMed 23790992Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. doi: 10.1016/j.pmr.2007.03.004.
PubMed 17543776Rajan S, McNeely MJ, Warms C, Goldstein B. Clinical assessment and management of obesity in individuals with spinal cord injury: a review. J Spinal Cord Med. 2008;31(4):361-72. doi: 10.1080/10790268.2008.11760738.
PubMed 18959353Laughton GE, Buchholz AC, Martin Ginis KA, Goy RE; SHAPE SCI Research Group. Lowering body mass index cutoffs better identifies obese persons with spinal cord injury. Spinal Cord. 2009 Oct;47(10):757-62. doi: 10.1038/sc.2009.33. Epub 2009 Apr 7.
PubMed 19350042Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Gater DR. The effects of electrical stimulation on body composition and metabolic profile after spinal cord injury--Part II. J Spinal Cord Med. 2015 Jan;38(1):23-37. doi: 10.1179/2045772314Y.0000000244. Epub 2014 Jul 8.
PubMed 25001669Cragg JJ, Noonan VK, Krassioukov A, Borisoff J. Cardiovascular disease and spinal cord injury: results from a national population health survey. Neurology. 2013 Aug 20;81(8):723-8. doi: 10.1212/WNL.0b013e3182a1aa68. Epub 2013 Jul 24.
PubMed 23884034Groah SL, Nash MS, Ward EA, Libin A, Mendez AJ, Burns P, Elrod M, Hamm LF. Cardiometabolic risk in community-dwelling persons with chronic spinal cord injury. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):73-80. doi: 10.1097/HCR.0b013e3181f68aba.
PubMed 21045711Eriks-Hoogland IE, Hoekstra T, de Groot S, Stucki G, Post MW, van der Woude LH. Trajectories of musculoskeletal shoulder pain after spinal cord injury: Identification and predictors. J Spinal Cord Med. 2014 May;37(3):288-98. doi: 10.1179/2045772313Y.0000000168. Epub 2013 Nov 7.
PubMed 24621031Alm M, Soroudi N, Wylie-Rosett J, Isasi CR, Suchday S, Rieder J, Khan U. A qualitative assessment of barriers and facilitators to achieving behavior goals among obese inner-city adolescents in a weight management program. Diabetes Educ. 2008 Mar-Apr;34(2):277-84. doi: 10.1177/0145721708314182.
PubMed 18375777Medina GI, Nascimento FB, Rimkus CM, Zoppi Filho A, Cliquet A Jr. Clinical and radiographic evaluation of the shoulder of spinal cord injured patients undergoing rehabilitation program. Spinal Cord. 2011 Oct;49(10):1055-61. doi: 10.1038/sc.2011.64. Epub 2011 Jul 5.
PubMed 21727901Jain NB, Higgins LD, Katz JN, Garshick E. Association of shoulder pain with the use of mobility devices in persons with chronic spinal cord injury. PM R. 2010 Oct;2(10):896-900. doi: 10.1016/j.pmrj.2010.05.004.
PubMed 20970758Brose SW, Boninger ML, Fullerton B, McCann T, Collinger JL, Impink BG, Dyson-Hudson TA. Shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury. Arch Phys Med Rehabil. 2008 Nov;89(11):2086-93. doi: 10.1016/j.apmr.2008.05.015.
PubMed 18996236Curtis KA, Drysdale GA, Lanza RD, Kolber M, Vitolo RS, West R. Shoulder pain in wheelchair users with tetraplegia and paraplegia. Arch Phys Med Rehabil. 1999 Apr;80(4):453-7. doi: 10.1016/s0003-9993(99)90285-x.
PubMed 10206610Dolbow DR, Gorgey AS, Ketchum JM, Moore JR, Hackett LA, Gater DR. Exercise adherence during home-based functional electrical stimulation cycling by individuals with spinal cord injury. Am J Phys Med Rehabil. 2012 Nov;91(11):922-30. doi: 10.1097/PHM.0b013e318269d89f.
PubMed 23085704
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI
- ClinicalTrials.gov ID
- NCT03810963
- Acronym / sponsor ID
- WilliamCareyU
- Conditions
- Spinal Cord Injuries
- Keywords
- High intensity interval training, functional electrical stimulation cycling, chronic spinal cord injury, cardiometabolic disease risk, body composition, body fat percentage, nutritional counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- William Carey UniversityUniversity, hospital or other
- Collaborators
- University of Southern Mississippi, University of Mississippi Medical Center
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| FES Cycling and Nutrition Counseling | Experimental | Combination Product: HIIT-FES Cycling combined with Nutritional CounselingDevice: 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. |
| Nutritional Counseling Only | Other | Other: Nutritional Counseling OnlyBehavior: Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT-FES Cycling combined with Nutritional CounselingHigh 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. | Combination product | FES Cycling and Nutrition Counseling |
| Nutritional Counseling OnlyNutritional counseling over the telephone for 30 minutes once per week for eight weeks. | Other | Nutritional Counseling Only |
Primary outcome
Body Fat Percentage
Time frame: Eight Weeks
Percentage of body fat measured during pre- and post-testing
Fat mass and lean mass
Time frame: Eight Weeks
Total fat and lean mass in kg measured during pre- and post-testing
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
Blood glucose testing
Time frame: 8 weeks
Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures
1 secondary outcome
Pre- post- intervention three day dietary recall
Time frame: Eight Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 15054345Conway JM, Ingwersen LA, Moshfegh AJ. Accuracy of dietary recall using the USDA five-step multiple-pass method in men: an observational validation study. J Am Diet Assoc. 2004 Apr;104(4):595-603. doi: 10.1016/j.jada.2004.01.007.
- Results publication: PubMed 23790992Froehlich-Grobe K, Lee J, Washburn RA. Disparities in obesity and related conditions among Americans with disabilities. Am J Prev Med. 2013 Jul;45(1):83-90. doi: 10.1016/j.amepre.2013.02.021.
- Results publication: PubMed 17543776Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. doi: 10.1016/j.pmr.2007.03.004.
- Results publication: PubMed 18959353Rajan S, McNeely MJ, Warms C, Goldstein B. Clinical assessment and management of obesity in individuals with spinal cord injury: a review. J Spinal Cord Med. 2008;31(4):361-72. doi: 10.1080/10790268.2008.11760738.
- Results publication: PubMed 19350042Laughton GE, Buchholz AC, Martin Ginis KA, Goy RE; SHAPE SCI Research Group. Lowering body mass index cutoffs better identifies obese persons with spinal cord injury. Spinal Cord. 2009 Oct;47(10):757-62. doi: 10.1038/sc.2009.33. Epub 2009 Apr 7.
- Results publication: PubMed 25001669Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Gater DR. The effects of electrical stimulation on body composition and metabolic profile after spinal cord injury--Part II. J Spinal Cord Med. 2015 Jan;38(1):23-37. doi: 10.1179/2045772314Y.0000000244. Epub 2014 Jul 8.
- Results publication: PubMed 23884034Cragg JJ, Noonan VK, Krassioukov A, Borisoff J. Cardiovascular disease and spinal cord injury: results from a national population health survey. Neurology. 2013 Aug 20;81(8):723-8. doi: 10.1212/WNL.0b013e3182a1aa68. Epub 2013 Jul 24.
- Results publication: PubMed 21045711Groah SL, Nash MS, Ward EA, Libin A, Mendez AJ, Burns P, Elrod M, Hamm LF. Cardiometabolic risk in community-dwelling persons with chronic spinal cord injury. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):73-80. doi: 10.1097/HCR.0b013e3181f68aba.
- Results publication: PubMed 24621031Eriks-Hoogland IE, Hoekstra T, de Groot S, Stucki G, Post MW, van der Woude LH. Trajectories of musculoskeletal shoulder pain after spinal cord injury: Identification and predictors. J Spinal Cord Med. 2014 May;37(3):288-98. doi: 10.1179/2045772313Y.0000000168. Epub 2013 Nov 7.
- Results publication: PubMed 18375777Alm M, Soroudi N, Wylie-Rosett J, Isasi CR, Suchday S, Rieder J, Khan U. A qualitative assessment of barriers and facilitators to achieving behavior goals among obese inner-city adolescents in a weight management program. Diabetes Educ. 2008 Mar-Apr;34(2):277-84. doi: 10.1177/0145721708314182.
- Results publication: PubMed 21727901Medina GI, Nascimento FB, Rimkus CM, Zoppi Filho A, Cliquet A Jr. Clinical and radiographic evaluation of the shoulder of spinal cord injured patients undergoing rehabilitation program. Spinal Cord. 2011 Oct;49(10):1055-61. doi: 10.1038/sc.2011.64. Epub 2011 Jul 5.
- Results publication: PubMed 20970758Jain NB, Higgins LD, Katz JN, Garshick E. Association of shoulder pain with the use of mobility devices in persons with chronic spinal cord injury. PM R. 2010 Oct;2(10):896-900. doi: 10.1016/j.pmrj.2010.05.004.
- Individual participant dataSharing planned: No. None currently
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Dolbow, DPT, PhD principal investigator
William Carey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT-FES Cycling combined with Nutritional Counseling and Nutritional Counseling Only in people with Spinal Cord Injuries, run by William Carey University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat Percentage (time frame: Eight Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810963, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.