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Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)


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    1. Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SCI (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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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 2,398,000deaths 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

    7. Risk factors associated with CVD 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

    8. 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

    9. 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

    10. Translating EvidenceQuestion: Are there interventions that can improve health in people 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

    11. 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

    12. FES Cycling ERGYS Muscle Power Therapeutic Technologies Inc., Alpha, Ohio • 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 Restorative Therapies, Baltimore, MD 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

    13. Health-related Benefits of FES CyclingSummary 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

    14. 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 16-70 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

    15. 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

    16. 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

    17. Summary of Outcome Measures 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

    18. 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. 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

    19. Demchak et al. 2005 • 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

    20. FES Cycling Parameters 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

    21. 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

    22. Demchak et al 2005: Results • Power Output • All participants demonstrated improvements in power output (2.4 +/- 0.88 watts at initial testing to 24.5 +/- 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

    23. 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

    24. 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

    25. 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

    26. 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

    27. 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

    28. 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

    29. Summary of Experimental Studiescontinued • 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

    30. Quasi-experimental studies • n= 1 • 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

    31. 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

    32. Bhambhani et al. 2000: Results * p<0.05 # significant difference (p<0.05) between SCI and able-bodied groups N signifies did not achieve maximal workout

    33. 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

    34. 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

    35. 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. 2007, 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

    36. 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

    37. Summary of Experimental & Quasi-Experimental Studies • 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

    38. Summary of Experimental & Quasi-Experimental Studies • 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

    39. Summary of Experimental & Quasi-Experimental StudiesMethodological 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

    40. Summary of Experimental & Quasi-Experimental StudiesMethodological 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

    41. 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

    42. Case reportJohnston 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

    43. 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

    44. Johnston et al. 2007Outcomes

    45. 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

    46. 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

    47. Repeated MeasuresArnold 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

    48. Arnold et al. 1992Intervention 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

    49. 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

    50. 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