Compiled by the Shepherd Center Study Group in Atlanta, GA

Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)
Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Review conducted using a system for rating the rigor and meaning of disability research (Farkas, Rogers and Anthony, 2008). The first instrument in this system is: “Standards for Rating Program Evaluation, Policy or Survey Research, Pre-Post and Correlational Human Subjects” (Rogers, Farkas, Anthony & Kash, 2008) and “Standards for Rating the Meaning of Disability Research” (Farkas & Anthony, 2008). Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Shepherd Center Systematic Review Group
Leadership team: Lesley Hudson, MS, David Apple, MD, Deborah Backus, PhD, PT Reviewers: Jennith Bernstein, PT Amanda Gillot, PT Ashley Kim, OT Elizabeth Sasso, PT Kristen Casperson, PT Brian Smith, PT Anna Berry, PT Angela Cooke, RN Data coordinator: Rebecca Acevedo Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Translating the Evidence
Question: Are people with SCI at risk for poor health and wellness? Why and in what way? Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Why Be Concerned with Health in People with SCI?
Average life expectancy of persons with spinal cord injury (SCI) has increased over the past 25 years (NSCISC, 2009) Cumulative survival rates of patients admitted into Spinal cord injury Model Systems of care (NSCISC, 2009): 69.14% (20 year survival) 51.97% (30 year survival) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Longevity Poses Health-Related Problems
Increase risk of same problems In the general population Cardiovascular disease (CVD) is the leading cause of death in the able-bodied American population Accounted for 36.3% (871,517) of all 2,398,000 deaths in the United States in 2004 (Rosamond et al, 2007) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Risk factors associated with CVD

CVD is associated with level & extent of injury in SCI
Persons with tetraplegia 16% increased risk of CVD Persons with paraplegia 70% increased risk of CAD Persons with complete injury 44% increased risk of CVD Groah et al, 2005 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Increased Risk of Mortality
Some reports suggest that the leading cause of mortality in SCI is CVD (Myers, Lee, Kiralti 2007) Spinal Cord Injury Model Systems (NSCISC, 2009) reports diseases of the respiratory system were the number one cause of death Clear that both respiratory and cardiovascular health are important variables to address in SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Translating Evidence Question: Are there interventions that can improve health in people with SCI?

Potential Interventions
Body-weight supported treadmill training (aka BWSTT) Electrical Stimulation Interventions Surface functional electrical stimulation (FES) FES cycling (upper and lower limb) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

FES Cycling ERGYS Muscle Power
Therapeutic Technologies Inc., Alpha, Ohio Restorative Therapies, Baltimore, MD Surface stimulation provided to bilateral gluteal, quadriceps and hamstring muscles Stimulation parameters varied slightly but major goal is to stimulate muscles for cyclical motion to pedal the ergometer Restorative Therapies include motor to passively cycle legs ERGYS ergometers require manual cycling to begin the cycling training Both can provide resistance to increase demand Typically exercise around 50rpm Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Health-related Benefits of FES Cycling Summary of Systematic Review
10 papers report on cardiorespiratory, pulmonary, metabolic, muscle or vascular effects of FES Cycling in people with SCI between 1989 and 2009 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of participants in studies
Level of injury All included people with paraplegia Most included people with tetraplegia International Standards of Classification All included people with motor complete injuries (AIS A or B) Several included people with motor incomplete (AIS C or D) Age range Most adults years Two with children 1 to 12 years Chronicity All but one included people with chronic injury Few included those with acute injury (< 1 year) Sex All included males All included females Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Research Designs of Included Studies
Experimental: Employed methods including a random assignment and a control group or a reasonably constructed comparison group; Quasi-experimental: No random assignment, but either with a control group or a reasonably constructed comparison group; Descriptive: Neither a control group, nor randomization, is used. These included case studies and reports, studies employing repeated measures, and Pre-post designs. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Research Design
Experimental approach n=2 Quasi-experimental approach n=1 Descriptive n=7 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Outcome Measures
Cardio/ Resp Muscular Metabolic Vascular Other Arnold et al. 1992 X Bhambhani et al. 2000 Demchak et al. 2005 ave weekly power output Faghri, Glaser, Faghri 1992 Fornusek & Davis et al. 2008 Power output Hooker et al. 1992 Johnston et al. 2007 Lipid levels, BMD Johnston et al. 2009 Lipids, cholesterol Theisen et al. 2002 Zbogar et al. 2008 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Two Randomized Control Trials
One was performed in adults with acute, motor complete (AIS A & B) paraplegia and tetraplegia (Demchak et al. 2005) The other in children with chronic, motor complete (AIS A & B) and motor incomplete (AIS C & D) paraplegia and tetraplegia (Johnston et al ) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Demchak et al. 2005 Included a group of able-bodied persons
Persons with SCI were randomized Control group Intervention group Participated in 30 minutes of training, 3 days a week for 13 weeks on the Stimaster Clinical Ergometry System (Electrologic of America, Inc. Dayton, Ohio) Included a group of able-bodied persons Major comparisons were reported between the SCI exercise group and the SCI control group Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

FES Cycling Parameters
Conditioning Cycling Additional info or training Device(s) used Stimulation parameters Freq Duration Demchak et al. 2005 perform 30 reps of knee ext with estim and 1 kg weight or able to cycle with 2.4 watts Began at 2 watts; 50rpm Increased every 3, 30 min sessions by 6.1 watts Stimaster Clinical Ergometry system 2 watts; max stim 140 mA 30 mins/day; 3 days/week 13 weeks Johnston et al. 2007 Lower extremity stretching prior to cycling At home; 50rpm RT300-P (FES) or RT100 (passive) 33Hz, 140mA 1 hour/day, 3X/week 6 months Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Demchak et al. 2005: Outcome Measures
Average weekly power output (calculated by the training device, the Stimaster Clinical Ergometry System (Electrologic of America, Inc. Dayton, Ohio) Needle biopsies of the vastus lateralis 4-6 weeks post-SCI, and then after one week of training on the FES cycle Nuclear density, fiber cross sectional area (CSA), and myosin heavy chain (MHC) composition were all computed from the biopsy findings. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Demchak et al 2005: Results Power Output Muscle cross sectional area
All participants demonstrated improvements in power output (2.4 +/ watts at initial testing to /- 3.2 watts at completion of training) SCI exercise group demonstrated increased power output by week 4 Muscle cross sectional area Prior to the intervention phase, both SCI groups demonstrated a 36% decrease in muscle CSA when compared to the able-bodied control group No difference in muscle CSA between the SCI groups at baseline The SCI exercise group demonstrated a non-significant 63% increase in muscle CSA after training (p=0.172) 171% greater than the CSA in persons in the SCI control group (p=0.05) There was no difference between groups in terms of nuclear density and myosin heavy chain (MHC) composition at baseline, and no significant difference in nuclear density or MHC composition in the SCI exercise group. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Demchak et al 2005: Summary of Findings
Increases in power output suggest ability to improve in training and place demand on the cardiorespiratory, musculoskeletal and vascular systems, even in those with acute SCI The changes in the muscle CSA suggest that early intervention with FES cycling in persons with acute, motor complete (AIS A or B) tetraplegia or paraplegia not only does not appear to harm the muscle, but also may prevent the early onset of muscle atrophy, and increase the health of the muscle fibers The clinical meaningfulness of the change seen here (171%) is not yet known Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2009 First randomized controlled trial in children
30 children ages 5-13 y.o. Chronic (> 1 year post-SCI), Complete or incomplete (AIS A, B, C) tetraplegia or paraplegia Evaluated the cardiorespiratory and vascular responses to FES cycling or passive cycling Performed in the home for 1 hour/day, 3 days/week for 6 months Randomized to 1 of three groups: FES cycling Passive cycling Non-cycling control group receiving electrical stimulation portable stimulation unit to bilaterally stimulate their hamstrings, quadriceps, and gluteal muscles, each for 20 minutes at a time, without resistance Same amount of time in therapy Children who were in the electrical stimulation group used a. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2009: Outcome Measures
Collected prior to training and upon completion of 6 months of training, and included: During incremental arm exercise test: Oxygen uptake (VO2) Heart rate (HR) Forced vital capacity (FVC) = the percentage of the norm based on age and height Cholesterol, HDLs, LDLS and triglycerides Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2009: Results
VO2 No difference between the three groups in terms of absolute values of VO2 peak at baseline and post-testing BUT significant difference in the average percent change: FES cycling group had a significantly greater increase in VO2 peak when compared to the passive cycling group HR, FVC No significant difference between group Lipid values No difference between groups at baseline and post-training However, when comparing average percentage change, the FES cycling group had significant decrease in cholesterol when compared to the passive cycling group Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2009: Summary of Findings
Children with chronic SCI may exercise safely with FES cycling FES cycling may lead to changes, and potentially improvements, in cardiorespiratory function and lipid profiles in children with chronic, complete SCI Improved health may lead to better participation in life activities, as well as long term health benefits in persons with early SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Experimental Studies
FES cycling may be a safe intervention, at least in relation to the muscle, in adults with acute SCI Early increases in cross sectional area, or even the prevention of the muscle atrophy that occurs early after SCI, may lead to improvements in glucose utilization, preventing or prolonging the onset of diabetes Increased muscle health and size may prevent skin breakdown and pressure sores, decreasing the long term costs associated with this secondary condition This was not studied in the one RCT performed in children and thus, it remains unclear what the effects would be in a developing muscle in children with SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Experimental Studies continued
FES cycling may be a safe intervention, in children with chronic, complete SCI and can lead to cardiorespiratory benefits, which may improve health in these children Although these parameters were not studied in adults, it is likely that they will have similar benefits with FES cycling, however, this requires further study Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Quasi-experimental studies
Bhambhani et al. 2000 Cross sectional study design to compare the effects of FES cycling during one test session on quadriceps muscle deoxygenation in persons with SCI and those that were able- bodied Participants were defined as having “complete lower limb paralysis”, but were not classified with any other classification system, such as International Standards of Classification (American Spinal Injury Association) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Bhambhani et al. 2000: Outcome Measures
Collected at rest, during exercise, during recovery Metabolic and cardiorespiratory measures: VO2, relative VO2 Minute ventilation (VE) Respiratory exchange ratio (RER) HR O2 pulse Muscle oxygenation - using Near Infrared Spectroscopy (NIRS) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Bhambhani et al. 2000: Results
SCI Able-bodied Exs Amount change VO2 # 2X  Linear changeN VE *# 3X Linear change HR * RER 1.10 Max exercise >1.10 Oxygenation No initial increase, immediate decline, remained stable, during recovery, increase throughout 4 mins Rate of decline in tissue absorbency per unit change in VO2 was faster than in Able-bodied persons Increase followed by decrease, rapid increase during first 2 mins of recovery, another increase until leveling off around 4 mins post-exs. * p<0.05 # significant difference (p<0.05) between SCI and able-bodied groups N signifies did not achieve maximal workout

Bhambhani et al. 2000: Summary of Findings
Both groups reached (SCI group) or exceeded (able-bodied group) the RER criterion of 1.10 set for this study Indicating maximal effort Significantly different responses between the SCI group and the able- bodied group Able-bodied group demonstrated a linear increase in all cardiorespiratory variables SCI group did not Demonstrated slight increases in VO2 and heart rate during each stage of testing VE increased significantly from rest in both groups (p<0.05), and by three times baseline in those with SCI. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Bhambhani et al. 2000: Summary of Findings continued
Muscle oxygenation responses differed significantly between groups Persons with SCI did not present with the initial increase in oxygenation at the onset with the systematic decrease as exercise progressed, and then a rapid increase during the recovery phase They presented with a decrease in oxygenation throughout the stages of exercise, and only slightly increased during the recovery period Increase in blood volume during the initial phase of exercise in the able-bodied persons No such increase in those with SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Bhambhani et al. 2000: Summary of Findings continued
Suggest an acute respiratory response to exercise, even in persons with chronic, motor complete SCI Similar to those in children with SCI who train on the FES cycle (Johnston et al , 2009) Responses do not simply mimic those in able-bodied persons Exercise programs for the SCI population need to be tailored to their specific health needs, and not simply fashioned after what appears effective for persons who are able-bodied Further study is needed to explore the muscle deoxygenation effects to determine if there are harmful effects of exercise, or if there are mechanisms for improving muscle deoxygenation and reoxygenation in those with muscle compromise due to SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Experimental & Quasi-Experimental Studies
FES cycling may lead to cardiorespiratory and muscle benefits in adults with acute and chronic SCI Children with chronic SCI may experience cardiorespiratory benefits Cardiorespiratory and muscle responses do not mimic those seen in persons who are not injured Exercise programs for persons with SCI need to be designed to address their specific needs Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Further research is warranted to elucidate the muscle-related effects of SCI Demchak et al. (2005) reported positive effects on muscle in persons with acute SCI Bhambhani et al. (2000) demonstrated a decrease in muscle function in those with chronic SCI Negative effects of exercise on muscle function, i.e. muscle oxygenation, in persons with SCI may be prevented by the introduction of FES cycling interventions earlier in the continuum of recovery Increases in muscle cross sectional area may not necessarily lead to the maintenance of fiber types after SCI, or better muscle oxygenation and deoxygenation with exercise Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Training on an FES cycle may be a viable option for improving health in those with SCI, and therefore prevent the stress on the upper extremities that exercises that use upper extremity muscles may cause Further study is required to determine the relative benefits of FES cycling and upper extremity exercises in persons with SCI. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Experimental & Quasi-Experimental Studies Methodological Considerations
Each study addressed different health-related problems in persons with different levels, chronicity and completeness of SCI Difficult to draw conclusions for the general SCI population The training duration was different for these three studies Demchak et al. -13 weeks Johnston et. al. - 6 months Bhambhani et al. - a single testing session Difficult to know which training paradigm would lead to the changes reported, and if another paradigm would lead to better or worse effects Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Experimental & Quasi-Experimental Studies Methodological Considerations
A study that explores the effects related to the same set of health-related variables across the continuum of recovery (acute and chronic), or in a single session at different points along the continuum, will yield more useful results and allow better decision making related to the use of FES cycling for persons with SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Descriptive studies Case studies/reports (n=1) Repeated measures (n=1)
Pre-Post test (n=5) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Case report Johnston et al. 2007
First report related to the potential for using FES cycling in children with SCI was conducted by Johnston et al (2007), later validated in 2009 Evaluated the effects of FES cycling with the RT300 or RT100 (Restorative Therapies Inc., Baltimore, MD) on musculoskeletal, cardiorespiratory and vascular measures In children with complete SCI (tetraplegia(n) = 2, paraplegia(n) = 2) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2007: Outcome Measures
The following measures were collected during incremental upper extremity ergometry test performed pre-training and after 6 months of training Muscle volume Muscle strength Spasticity Fasting lipid profile HR VO2 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2007 Outcomes
FES Cycling (RT300) Passive Cycling (RT100) 1 2 3 4 Age 7 9 11 Sex F M Level of injury T4-6 C7 T3 AIS A Time since injury 2 years 4 years 3 years Muscle volume Increased No change Quadriceps strength Decreased HDL LDL triglycerides Resting HR Peak VO2 Not tested Peak HR Ashworth score No change (subjective reports of decrease)

Johnston et al./ 2007: Results
Adherence to the training program > 90% children will perform this form of exercise at least for a 6-month period of time, and in the home The two children who cycled with FES showed increases in quadriceps muscle volume and strength (45.6%, 52.3%, and 289.3%, 173.6%, respectively) Only one child who performed passive cycling demonstrated: improvement in strength (212.3%) much less increase in volume (15.3%). The child with paraplegia who performed training on the FES cycle demonstrated: a decline in resting and peak heart rate an increase in VO2 max The child with tetraplegia did not experience these same changes, and only demonstrated a decreased resting heart rate One child who exercised passively on the cycle demonstrated an increase in VO2 max The lipid profiles were not consistent, and require further study in children performing aerobic exercise Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Johnston et al. 2007: Summary of Findings
The findings from this case study, which were further substantiated after the randomized controlled trial in 2009, suggest that: FES cycling is a viable option for improving cardiorespiratory health in children with chronic complete or incomplete SCI Findings related to lipid profiles remain unclear and require further study The responses in children are similar to those reported in adults Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Repeated Measures Arnold et al. 1992
Studied the safety and efficacy of FES cycling 2 persons with either acute or chronic, complete (n=9) or incomplete (n=1) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Arnold et al. 1992 Intervention
Timeline representing the phases of training for the study _________________________________________ Phase 1 Phase 2 Phase 3 Estim leg extension FES cycling 30 minutes FES cycle with resistance Goal: 45 leg ext with 5lb 30 minutes at 50rpm Increase by 1/8Kp 1 wk – 4 months 1 month – 4 months No limit Outcomes assessed 2.5 months Outcomes 2.5 months Outcomes 6 months Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Arnold et al. 1992: Outcome Measures
Pulmonary function was assessed approximately 2.5 months into phase 1 again 2.5 months into phase 2 finally, after 6 months in phase 3 Cardiorespiratory outcome measures included: tidal volume (TV) VO2 RER Muscle was measured using: girth measurements of the thigh and calf Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Arnold et al. 1992: Results All parameters improved after training, during all phases Significant changes in TV in phase one when compared to phases two (p<0.001) and three (p<0.001) VO2 increased significantly during phase two (cycling) (p<0.002) and phase three (resistance) when compared to phase one (leg extension) All participants showed a significant increase in thigh girth bilaterally (p<0.002 for right, and p<0.001 for left) over the course of all three phases No change in the non-stimulated the calf muscles Support those reported earlier that FES cycling may yield cardiorespiratory and muscle health benefits in persons with complete, and potentially those with incomplete (n=1), SCI Also noted rapid increase during early phases of exercise, as well as those later in the training Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Pre-Post Testing Two studies used the pre-post design to study the effects of FES cycling on cardiorespiratory, metabolic and vascular systems Faghri et al 1992, Hooker et al. 1992 Both studied the cardiorespiratory and vascular effects in a similar participant population Predominantly male adults Complete (AIS A) or incomplete (AIS B, C, D) Paraplegia or tetraplegia Hooker et al. (1992) included persons with acute or chronic SCI Faghri et al. (1992) only included those with chronic injury. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Faghri et al. 1992 Effects of FES cycling on cardiorespiratory and vascular responses 13 persons with motor complete (AIS A or B) or motor incomplete (AIS C or D) chronic SCI (tetraplegia(n)=7, paraplegia(n)=6) NOTE: The degree of completeness was determined by the Frankel scale (American Spinal Injury Association, 1990) Training: All participants completed 36, 30-minute sessions of training in an average of 13 weeks If participants became fatigued during a session, then they were allowed to have three attempts to complete the 30 minutes When capable of completing three consecutive 30 minute sessions, resistance was increased by 6.1 watts Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Faghri et al. 1992 Outcome Measures
Collected before and after the 36 sessions Included metabolic and cardiorespiratory testing at rest and during 5 minutes of FES cycling at 0-W power output Measures: VO2 VCO2 VE RER SV Cardiac output HR DBP and SBP Mean arterial pressure (MAP) Total peripheral resistance (TPR) were then calculated. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Faghri et al. 1992: Results * p<0.05
Tetraplegia Paraplegia Rest Submax Exs Rest to Exs VO2 NC * RER VE Q SV HR * MAP SBP DBP TPR * p<0.05 Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Faghri et al. 1992: Results All participants with SCI improved from initially being unable to complete the 30 minute sessions to being able to complete 30 minutes of continuous exercise Participants were able to increase the resistance during cycling Persons with tetraplegia improved to a mean PO of 17.4+/- 2.9W Persons with paraplegia improved to a mean of /-3.5W All participants demonstrated changes in respiratory, cardiac and vascular (except MAP and DBP) Suggests an acute exercise response Both groups demonstrated changes in some cardiac variables (SV and HR) and some vascular variables (SBP, DBP, MAP) Only the group with persons with paraplegia demonstrated significant changes in TPR (i.e. a decrease) both at rest and during the submaximal exercise test post-36 sessions of FES cycling training . Furthermore, the group with persons with paraplegia also demonstrated: Increases in SV Decreases in all vascular variables at rest post-training Suggests that persons with different levels of injury (namely tetra-versus paraplegia) respond differently during exercise Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Hooker et al. 1992 Intervention
Also evaluated the effects of FES cycling on physiological responses during both a FES cycle stress test, and an untrained upper extremity stress test Males (n=17) and one female Acute or chronic complete or incomplete SCI Training similar to Faghri et al. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Hooker et al. 1992: Outcome Measures
VO2 VE VCO2 RER (VCO2/ VO2) SV CO HR MAP TPR Data was analyzed for persons with paraplegia and tetraplegia together Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Hooker et al. 1992: Results Their findings were essentially the same as those from the study reported by Faghri et al (1992) All participants were able to increase power output over the time of FES cycle training The most rapid change in power output was seen during the first 4 weeks of training Significant increase in power output seen between pre- and post-testing with the FES cycle stress test No change in power output for the upper extremity stress test Significant increase in power output, VO2, VE, and HR during the post-training on the FES cycle stress test, as well as a lowered TPR No significant changes in peak SV, MAP or RER The lack of change may be due to analyzing the data from persons with tetraplegia and those with paraplegia together Responses have been shown to vary based on level of injury No significant changes in any variables during the upper extremity stress test Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Zbogar et al. 2008 Studied the effects of FES cycling on arterial compliance 4 females chronic, tetraplegia (n=2, AIS B, C4 and C5) and paraplegia (n=2, T4, AIS A and T7, AIS C) Training on an ERGYS 2 (Therapeutic Alliances Inc, Ohio, USA) Each participant first habituated on the FES cycle so that they were all able to train for 30 consecutive minutes Then trained for 30 minutes average 1.9 days a week, for 12 weeks Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Zbogar et al. 2008 Outcome Measures
Collected 2 to 7 days after completion of the habituation period Also 2 to 7 days after completion of the training Large and small arterial compliance using an applanation tonometer (Hypertension Diagnostics/Pulse Wave CR-3000; Eagan, MN, USA) Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Zbogar et al. 2008: Results Initial values for small arterial compliance were 53% less than age and sex matched historical controls Initial values for large arterial compliance was within normal values No significant change in large arterial compliance after training average change was only 5% across the group Significant increase in small arterial compliance (p<0.05) Significant increase (p=0.05) of 63% from starting values To about 88% of normal values Suggest vascular effects from training on an FES cycle in women with chronic sensory and motor incomplete SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Testing only (no training)
Two studies evaluated acute responses and did not involve participant training Theisen et al. (2002) studied the effects of 40 minutes of cycling on power output in Five adult (4 males, 1 female) Chronic AIS A Paraplegia (T4-T9) Performed 40 minutes of cycling on a MOTOmed Viva cycle ergometer (Reck, Germany) Fornusek et al. (2008) studied the effects of FES cycling on cardiorespiratory and muscle oxygenation responses at different cadences Paraplegia Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Theisen et al. 1992 Data were averaged over 30 second periods
Seated on the ergometer, they rested 10 minutes, then started cycling with a motor at 50rpm Stimulation was triggered after the first 5-10 revolutions of the crank, and increased to mA After this point, stimulation amplitude remained constant. Throughout cycling collected: VO2 VCO2 VE HR Data were averaged over 30 second periods Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Theisen et al. 2008 Results Strong time-dependent response PO VO2 HR
Reached maximal level at 6 minutes of exercise After 6 mins, power output dropped Progressively increased after 19.5 minutes of cycling Towards the end of exercise, the power output again decreased slightly. VO2 Also increased significantly from rest after 2 and 6 minutes of cycling Decreased again at 40 minutes of cycling HR decreased initially but then increased to a value significantly higher than the resting value Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Fornusek et al. 2008: Participants performed an exercise test 1X/week for 3 weeks Order of testing was randomly controlled for the cadence being tested 15, 30, or 50rpm Outcome measures Cardiorespiratory responses Muscle oxygenation was measured NIRS Collected throughout the exercise session Each exercise test session lasted 35 minutes Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Fornusek et al. 2008: Results
15rpm 30rpm 50rpm Passive Power output 6.3+/-0.6 8.2+/-0.7 7.9+/-0.5 No change from rest VO2  VE RER HR Stroke volume Gross mechanical efficiency 2.0+/-0.2 2.6+/-0.2 2.5+/-0.2 Muscle oxygenation saturation  initially then  at 25 mins. * *p<0.05 Although the power output differed at the three different cadences, there were no significant differences in the variables measured between the cadences. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Descriptive Studies
Children and adults with both acute and chronic SCI who train with FES cycling can achieve cardiorespiratory, vascular and muscle improvements Persons with tetraplegia do not respond in the same fashion as those with paraplegia to this exercise in terms of cardiorespiratory and vascular responses Persons with tetraplegia may have more autonomic disruption that may impact their exercise response Exercise programs designed for persons with tetraplegia may need to be different or modified from those with paraplegia Exercising at different cadences may not impact power output and acute responses to exercise Remains unclear what the impact would be with training for longer duration at the different cadences Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary of Descriptive Studies continued
Passive cycling may lead to cardiorespiratory benefits in some persons with SCI Future study should include a careful comparison between passive and FES cycling in persons with SCI The cost of these two devices is different (i.e., passive cycles are less expensive), and if certain persons can obtain the desired health-related benefits with a less expensive tool or device, this would be desirable Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Conclusions Based on Systematic Review
The following persons may experience cardiorespiratory benefits from FES cycling: Adults & children with complete tetraplegia or paraplegia between C4 and T11 Adults & children with incomplete tetraplegia or paraplegia between C4 and T11 Adults with acute or chronic SCI Children with chronic SCI The following persons may experience muscle related benefits from FES cycling: Adults with acute or chronic complete or incomplete tetraplegia or paraplegia; Adults with acute or chronic, complete or incomplete SCI may experience positive changes in vascular function that may improve cardiac health Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

The changes in cardiorespiratory, vascular and muscle function are meaningful May lead to a decrease in the risk factors associated with CVD May increase longevity after SCI May lead to greater health and quality of life in persons with SCI In addition to these findings, some points related to safety and application of these training approaches: Changes in heart rate and blood pressure appear to vary based on level of injury, and not intensity of the exercise Those with tetraplegia do not demonstrate the same response to exercise as those with paraplegia, and this is most likely due to the autonomic dysfunction that accompanies cervical level injury. Caution should be taken to prevent cardiac disturbances or breakdown due to the training or the harness, respectively. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Considerations for future study: Variable responses in vascular responses and lipid profiles require further study FES cycling and passive cycling have not been compared in relation to the exercise and health-related benefits Include cost-benefit analyses to allow persons with SCI, and their payers, to make well-informed choices about which intervention would be most productive and cost-efficient for that person To elucidate the differential responses and benefits to FES cycling and BWSTT approaches for persons with different levels, completeness (AIS classification) and chronicity of SCI. FES cycling, BWSTT approaches and upper extremity exercise should be compared for their relative contributions to exercise and health-related benefits in SCI Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Final recommendations related to training with FES cycling and BWSTT: Persons with SCI who desire pursuing FES cycling for improving health and wellness should discuss with their health care provider the intensity and duration of the program required to effect a change in cardiorespiratory, muscle, vascular, or metabolic variables based on the level, extent and chronicity of their SCI. Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Thank you! National Institute Disability Rehabilitation Research
Lesley Hudson, MS David Apple, MD Shepherd Center Jennith Bernstein, PT Amanda Gillot, PT Ashley Kim, OT Elizabeth Sasso, PT Kristen Casperson, PT Brian Smith, PT Anna Berry, PT Angela Cooke, RN Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Compiled by the Shepherd Center Study Group in Atlanta, GA

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Compiled by the Shepherd Center Study Group in Atlanta, GA

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