systematic review of the exercise or health-related benefits of fes cycling after sc i (1989-2009)

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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

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Page 1: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

Page 2: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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).

2Compiled 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

Page 3: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Shepherd Center Systematic Review Group

Leadership team: Lesley Hudson, MS, David Apple, MD, Deborah Backus, PhD, PT

Reviewers:Jennith Bernstein, PTAmanda Gillot, PTAshley Kim, OTElizabeth Sasso, PTKristen Casperson, PTBrian Smith, PTAnna Berry, PTAngela Cooke, RN

Data coordinator: Rebecca Acevedo3

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

Page 4: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Translating the EvidenceQuestion:

Are people with SCI at risk for poor health and wellness?Why and in what way?

4Compiled 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

Page 5: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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)

5Compiled 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

Page 6: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Longevity Poses Health-Related Problems

Increase risk of same problems In the general populationCardiovascular 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)

6Compiled 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

Page 7: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Risk factors associated with CVD

General Risk Factor Exacerbated in SCI

Obesity **

Lipid disorders **

Heredity

Male

Advanced age

cigarette smoking **

High Blood Pressure

Diabetes

Lack of physical activity

**

**

7Compiled 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

Page 8: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

8Compiled 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

Page 9: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

9Compiled 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

Page 10: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Translating Evidence

Question: Are there interventions that can

improve health in people with SCI?

10Compiled 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

Page 11: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Potential Interventions

Body-weight supported treadmill training (aka BWSTT)

Electrical Stimulation InterventionsSurface functional electrical stimulation

(FES)FES cycling (upper and lower limb)

11Compiled 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

Page 12: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

FES Cycling

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

ERGYS Muscle Power

Therapeutic Technologies Inc.,

Alpha, Ohio

12Compiled 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

Page 13: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

13Compiled 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

Page 14: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of participants in studies

Level of injuryAll included people with paraplegiaMost included people with tetraplegia

International Standards of ClassificationAll 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 yearsTwo with children 1 to 12 years

ChronicityAll but one included people with chronic injuryFew included those with acute injury (< 1 year)

SexAll included malesAll included females

14Compiled 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

Page 15: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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.

15Compiled 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

Page 16: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Research DesignExperimental approach n=2Quasi-experimental approach n=1Descriptive n=7

16Compiled 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

Page 17: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Outcome Measures

Outcome Measures

Cardio/

RespMuscular Metabolic Vascular

Other

Arnold et al. 1992 X X X

Bhambhani et al. 2000 X X

Demchak et al. 2005 Xave weekly

power outputFaghri, Glaser, Faghri 1992 X

Fornusek & Davis et al. 2008 X Power output

Hooker et al. 1992 X X Power output

Johnston et al. 2007 X X XLipid levels,

BMD

Johnston et al. 2009 X XLipids,

cholesterol

Theisen et al. 2002 X X Power output

Zbogar et al. 2008 X

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 Rehabilitation17

Page 18: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Two Randomized Control TrialsOne 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)

18Compiled 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

Page 19: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Demchak et al. 2005 Persons with SCI were randomized

Control groupIntervention 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 personsMajor comparisons were reported between

the SCI exercise group and the SCI control group

19Compiled 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

Page 20: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

FES Cycling ParametersConditioning 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 Ergomet

ry system

2 watts; max stim

140 mA

30 mins/day

; 3 days/we

ek

13 weeks

Johnston et al. 2007

Lower extremit

y stretching prior

to cycling

At home; 50rpm

RT300-P (FES) or RT100

(passive)

33Hz, 140mA

1 hour/day

, 3X/week

6 month

s20

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

Page 21: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Demchak et al. 2005: Outcome MeasuresAverage 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 cycleNuclear density, fiber cross sectional area

(CSA), and myosin heavy chain (MHC) composition were all computed from the biopsy findings.

21Compiled 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

Page 22: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Demchak et al 2005: ResultsPower 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 areaPrior 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 baselineThe 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.

22Compiled 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

Page 23: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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 fibersThe clinical meaningfulness of the change seen here

(171%) is not yet known

23Compiled 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

Page 24: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Johnston et al. 2009First 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

monthsRandomized to 1 of three groups:

FES cyclingPassive cyclingNon-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 therapyChildren who were in the electrical stimulation group used

a.

24Compiled 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

Page 25: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Johnston et al. 2009: Outcome MeasuresCollected 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 triglycerides25

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

Page 26: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Johnston et al. 2009: ResultsVO2

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 groupHR, 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

26Compiled 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

Page 27: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

27Compiled 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

Page 28: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Experimental Studies

FES cycling may be a safe intervention, at least in relation to the muscle, in adults with acute SCIEarly 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

28Compiled 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

Page 29: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Experimental StudiescontinuedFES cycling may be a safe intervention, in

children with chronic, complete SCI and can lead to cardiorespiratory benefits, which may improve health in these childrenAlthough these parameters were not studied in

adults, it is likely that they will have similar benefits with FES cycling, however, this requires further study

29Compiled 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

Page 30: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Quasi-experimental studiesn= 1Bhambhani et al. 2000Cross 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)

30Compiled 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

Page 31: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Bhambhani et al. 2000: Outcome Measures

Collected at rest, during exercise, during recovery

Metabolic and cardiorespiratory measures:VO2, relative VO2Minute ventilation (VE)Respiratory exchange ratio (RER)HRO2 pulseMuscle oxygenation - using Near Infrared

Spectroscopy (NIRS)31

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

Page 32: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Bhambhani et al. 2000: Results

SCI Able-bodied

Exs Amount change Exs Amount

changeVO2 # 2X

Linear changeN

VE *# 3X Linear change

HR # * Linear change

RER 1.10 Max exercise >1.10 Max

exercise

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 groupsN signifies did not achieve maximal workout 32

Page 33: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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 studyIndicating maximal effort

Significantly different responses between the SCI group and the able-bodied groupAble-bodied group demonstrated a linear increase in all

cardiorespiratory variablesSCI 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.

33Compiled 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

Page 34: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Bhambhani et al. 2000: Summary of Findings continued

Muscle oxygenation responses differed significantly between groupsPersons 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 personsNo such increase in those with SCI

34Compiled 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

Page 35: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Bhambhani et al. 2000: Summary of Findings continued

Suggest an acute respiratory response to exercise, even in persons with chronic, motor complete SCISimilar 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

personsExercise 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

35Compiled 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

Page 36: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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 injuredExercise programs for persons with SCI need

to be designed to address their specific needs

36Compiled 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

Page 37: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Experimental & Quasi-Experimental Studies

Further research is warranted to elucidate the muscle-related effects of SCIDemchak et al. (2005) reported positive effects on

muscle in persons with acute SCIBhambhani et al. (2000) demonstrated a decrease in

muscle function in those with chronic SCINegative 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

37Compiled 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

Page 38: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Experimental & Quasi-Experimental StudiesTraining 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.

38Compiled 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

Page 39: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Experimental & Quasi-Experimental StudiesMethodological ConsiderationsEach study addressed different health-related

problems in persons with different levels, chronicity and completeness of SCIDifficult to draw conclusions for the general SCI

populationThe training duration was different for these

three studiesDemchak et al. -13 weeksJohnston et. al. - 6 monthsBhambhani et al. - a single testing sessionDifficult to know which training paradigm would lead to

the changes reported, and if another paradigm would lead to better or worse effects39

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

Page 40: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Summary of Experimental & Quasi-Experimental StudiesMethodological ConsiderationsA 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

40Compiled 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

Page 41: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Descriptive studiesCase studies/reports (n=1)Repeated measures (n=1)Pre-Post test (n=5)

41Compiled 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

Page 42: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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)

42Compiled 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

Page 43: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Johnston et al. 2007: Outcome MeasuresThe following measures were collected during

incremental upper extremity ergometry test performed pre-training and after 6 months of trainingMuscle volumeMuscle strengthSpasticityFasting lipid profileHRVO2

43Compiled 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

Page 44: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Johnston et al. 2007Outcomes

FES Cycling (RT300) Passive Cycling (RT100)

1 2 3 4Age 7 9 7 11

Sex F F M M

Level of injury T4-6 C7 T3 C7

AIS A A A A

Time since injury 2 years 4 years 4 years 3 years

Muscle volume Increased Increased No change Increased

Quadriceps strength

Increased Increased Decreased Increased

HDL Increased Decreased Decreased Decreased

LDL Increased Increased Increased Decreased

triglycerides Increased Increased Decreased No change

Resting HR Decreased Decreased Decreased Decreased

Peak VO2 Increased No change Not tested Increased

Peak HR Decreased No change Increased No change

Ashworth score No change (subjective reports of decrease)

No change Decreased No change

44

Page 45: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

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Page 46: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

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Page 47: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Repeated MeasuresArnold et al. 1992Studied the safety and efficacy of FES

cycling2 persons with either acute or chronic,

complete (n=9) or incomplete (n=1)

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Page 48: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Arnold et al. 1992Intervention

Timeline representing the phases of training for the study

   _________________________________________

Phase 1 Phase 2 Phase 3Estim leg extension FES cycling 30 minutes FES cycle with

resistanceGoal: 45 leg ext with 5lb 30 minutes at 50rpm Increase by 1/8Kp1 wk – 4 months 1 month – 4 months No limitOutcomes assessed 2.5 months Outcomes 2.5 months Outcomes

6 months

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Page 49: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Arnold et al. 1992: Outcome MeasuresPulmonary function was assessed

approximately 2.5 months into phase 1again 2.5 months into phase 2finally, 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

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Page 50: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Arnold et al. 1992: ResultsAll 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 phasesNo 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

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Page 51: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Pre-Post TestingTwo studies used the pre-post design to study

the effects of FES cycling on cardiorespiratory, metabolic and vascular systemsFaghri et al 1992, Hooker et al. 1992Both studied the cardiorespiratory and vascular

effects in a similar participant populationPredominantly male adultsComplete (AIS A) or incomplete (AIS B, C, D) Paraplegia or tetraplegiaHooker et al. (1992) included persons with acute or chronic

SCIFaghri et al. (1992) only included those with chronic injury.

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Faghri et al. 1992Effects of FES cycling on cardiorespiratory and

vascular responses13 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 weeksIf 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

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Faghri et al. 1992Outcome MeasuresCollected before and after the 36 sessionsIncluded metabolic and cardiorespiratory testing

at rest and during 5 minutes of FES cycling at 0-W power output

Measures:VO2VCO2VE RER SVCardiac outputHRDBP and SBPMean arterial pressure (MAP)Total peripheral resistance (TPR) were then calculated.

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Page 54: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Faghri et al. 1992: Results

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Tetraplegia Paraplegia

Rest Submax Exs Rest to Exs Rest Submax Exs Rest to Exs

VO2 NC NC * NC NC *

RER NC NC * NC NC *

VE NC NC * NC NC *

Q NC NC * NC NC *

SV NC * * * * *

HR * * * NC * *

MAP NC * NC * * NC

SBP * * * * * *

DBP NC * NC * * NC

TPR NC NC * * * *

* p<0.05

Page 55: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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 17.1 +/-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

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Page 56: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Hooker et al. 1992InterventionAlso 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

SCITraining similar to Faghri et al.

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Page 57: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

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Hooker et al. 1992: ResultsTheir 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 trainingThe 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 RERThe 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

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Page 59: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Zbogar et al. 2008Studied the effects of FES cycling on

arterial compliance4 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 minutesaverage 1.9 days a week, for 12 weeks

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Zbogar et al. 2008Outcome Measures

Collected 2 to 7 days after completion of the habituation period

Also 2 to 7 days after completion of the trainingLarge and small arterial compliance using an

applanation tonometer (Hypertension Diagnostics/Pulse Wave CR-3000; Eagan, MN, USA)

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Zbogar et al. 2008: ResultsInitial values for small arterial compliance were 53%

less than age and sex matched historical controlsInitial values for large arterial compliance was within

normal valuesNo significant change in large arterial compliance

after trainingaverage 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 valuesTo about 88% of normal values

Suggest vascular effects from training on an FES cycle in women with chronic sensory and motor incomplete SCI

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Page 62: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Testing only (no training)Two studies evaluated acute responses and did not

involve participant trainingTheisen 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 cadencesAIS AParaplegia

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Theisen et al. 1992Seated on the ergometer, they rested 10 minutes,

then started cycling with a motor at 50rpmStimulation was triggered after the first 5-10

revolutions of the crank, and increased to 120-140mAAfter this point, stimulation amplitude remained

constant.Throughout cycling collected:

VO2VCO2VEHR

Data were averaged over 30 second periods63

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Page 64: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Theisen et al. 2008ResultsStrong time-dependent response

PO Reached maximal level at 6 minutes of exerciseAfter 6 mins, power output droppedProgressively increased after 19.5 minutes of cyclingTowards 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 cyclingHR

decreased initially but then increased to a value significantly higher than the resting value

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Page 65: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Fornusek et al. 2008:

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Participants performed an exercise test 1X/week for 3 weeks

Order of testing was randomly controlled for the cadence being tested15, 30, or 50rpm

Outcome measuresCardiorespiratory responsesMuscle oxygenation was measured NIRSCollected throughout the exercise sessionEach exercise test session lasted 35 minutes

Page 66: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Fornusek et al. 2008: Results

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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. *

initially then at 25 mins. *

initially then at 25 mins. *

*p<0.05Although the power output differed at the three different cadences, there were no significant differences in the variables measured between the cadences.

Page 67: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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 responsesPersons with tetraplegia may have more autonomic disruption

that may impact their exercise responseExercise programs designed for persons with tetraplegia may

need to be different or modified from those with paraplegiaExercising at different cadences may not impact power

output and acute responses to exerciseRemains unclear what the impact would be with training for

longer duration at the different cadences

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Summary of Descriptive Studiescontinued

Passive cycling may lead to cardiorespiratory benefits in some persons with SCIFuture study should include a careful comparison between

passive and FES cycling in persons with SCIThe 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

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Page 69: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

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

T11Adults & children with incomplete tetraplegia or paraplegia between C4

and T11Adults with acute or chronic SCIChildren 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;Children with chronic SCI

Adults with acute or chronic, complete or incomplete SCI may experience positive changes in vascular function that may improve cardiac health

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Page 70: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Conclusions Based on Systematic Review

The changes in cardiorespiratory, vascular and muscle function are meaningfulMay lead to a decrease in the risk factors associated with CVDMay increase longevity after SCIMay 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.

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Conclusions Based on Systematic Review

Considerations for future study:Variable responses in vascular responses and lipid profiles require

further studyFES 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

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Page 72: Systematic Review of the Exercise or Health-Related Benefits of FES Cycling after SC I (1989-2009)

Conclusions Based on Systematic Review

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.

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Thank you!

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