Shepherd Center Systematic Review Group

Exercise or Health-Related Benefits of FES Cycling after

SCI

Summary of a Research Synthesis for the Health Care Provider

Shepherd Center Study Group

1

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 GroupLeadership team: Lesley Hudson, MS; David

Apple, MD; Deborah Backus, PhD, PT Health-related Reviewers:

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

Data coordinator: Rebecca Acevedo

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

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).

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Table of contents Background and purpose of review pp. 5 Possible interventions pp. 12 Overview of review pp. 14 Participants pp. 15 Research Design pp. 16 Summary of outcome measures pp. 18 Experimental design pp.19 Quasi-experimental (quasi-expt)design pp. 33 Summary of experimental and & quasi-expt pp. 40 Descriptive design pp. 45 Summary descriptive pp. 76 Conclusions pp. 78 Acknowledgements pp. 84


(H133A050006) at Boston University Center for Psychiatric Rehabilitation4

Translating the Evidence

Question: Are people with SCI at risk for poor health and

wellness?Why and in what way?

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)

6



Longevity Poses Health-Related Problems

Increased risk of same problems in the general populationCardiovascular disease (CVD) is the leading cause of

death in the able-bodied American populationAccounted for 36.3% (871,517) of all 2,398,000 deaths in

the United States in 2004 (Rosamond et al, 2007)

7



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

**

**

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

CVD: Associated with level & extent of SCI

Persons with tetraplegia 16% increased risk of Cardiovascular Disease (CVD)

Persons with paraplegia 70% increased risk of Coronary Artery Disease (CAD)

Persons with complete injury 44% increased risk of CVD

Groah et al, 2005

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

10



Translating Evidence

Question: Do interventions using functional

electrical stimulation cycles or locomotor devices improve variables related to health in people with SCI?

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

Potential Interventions

Body-weight supported treadmill training (aka BWSTT)

Electrical Stimulation InterventionsSurface functional electrical stimulation (FES)

FES cycling (upper and lower limb)

12



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 PowerTherapeutic

Technologies Inc., Alpha, Ohio

13



Health-related Benefits of FES Cycling

10 papers report on cardiorespiratory, pulmonary, metabolic, muscle or vascular effects of FES Cycling in people with SCI between 1989 and 2009

14



Summary of participantsLevel of injury

All 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 males and females

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Research Designs Included

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.

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Summary: Research Design

Experimental approach n=2Quasi-experimental approach n=1Descriptive n=7

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Summary: Outcome Measures

Outcome Measures

Cardio/Resp

Muscular

Metabolic

Vascular

Other

Arnold et al. 1992

X X X

Bhambhani et al. 2000

X X

Demchak et al. 2005

Xave weekly

power output

Faghri, Glaser, Faghri 1992

X

Fornusek & Davis et al. 2008

XPower output

Hooker et al. 1992

X XPower output

Johnston et al. 2007

X X XLipid

levels, BMD


X XLipids,

cholesterolTheisen et al. 2002

X XPower output

Zbogar et al. 2008

X

18

Experimental Design

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Randomized Control Trials (RCT)

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) paraplegia and tetraplegia (Johnston et al. 2009)

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FES Cycling Parameters of RCT

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 Ergometr

y system

2 watts; max

stim 140 mA

30 mins/day;

3 days/wee

k

13 weeks


Lower extremity stretching

prior to cycling

At home; 50rpm

RT300-P (FES) or RT100

(passive)

33Hz, 140mA

1 hour/day, 3X/week

6 months

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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

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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 cycleNuclear density, fiber cross sectional area (CSA), and

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

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Demchak et al 2005: Results

Power OutputAll participants demonstrated improvements in power

output (2.4 +/- 0.88 watts pre to 24.5 +/- 3.2 watts post)

SCI exercise group demonstrated increased power output by week 4

Muscle cross sectional area (CSA)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)

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Demchak et al 2005: Resultscontinued

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.

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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

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First randomized control trial in children30 children ages 5-13 y.o.Chronic (> 1 year post-SCI)Complete or incomplete (AIS A, B, C) tetraplegia or

paraplegiaEvaluated the cardiorespiratory & 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 3 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 therapy

27



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

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Johnston et al. 2009: Results

VO2 No difference between the three groups in terms of

absolute values of VO2 peak at baseline and post-testingBUT 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, FVCNo significant difference between group

Lipid values No difference between groups at baseline and post-

trainingHowever, when comparing average percentage change,

the FES cycling group had significant decrease in cholesterol when compared to the passive cycling group

29



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 pediatric-onset SCI

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Summary: Experimental StudiesFES 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

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Summary: 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 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

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Quasi-Experimental Design



Bhambhani et al. 2000

n= 1Cross 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)

34



Bhambhani et al. 2000: Outcome Measures

Collected at rest, during exercise, during recoveryMetabolic and cardiorespiratory measures:

VO2, relative VO2

Minute ventilation (VE)Respiratory exchange ratio (RER)HRO2 pulseMuscle oxygenation - using Near Infrared Spectroscopy

(NIRS)

35



Bhambhani et al. 2000: Results

SCI Able-bodied

ExsAmount change

ExsAmount change

VO2 # 2X Linear

changeN

VE *# 3X Linear change

HR # * Linear change

RER 1.10Max

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/unit change in

VO2 faster than in AB

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 (AB); N=did not achieve maximal workout

36Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination &

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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.

37



Bhambhani et al. 2000: Summary of Findingscontinued

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

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Bhambhani et al. 2000: Summary of Findings continued

Suggest 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 in SCI do not simply mimic those in AB

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

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Summary: 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

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Quasi-Experimental StudiesFurther 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

41




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.

42

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Quasi-Experimental StudiesMethodological Considerations

Each study addressed different health-related problems in persons with different levels, chronicity and completeness of SCIDifficult to draw conclusions for the general SCI population

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 effects

43


Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation


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

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Descriptive Study Design



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

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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)

47



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 trainingMuscle volumeMuscle strengthSpasticityFasting lipid profileHRVO2

48



Johnston et al. 2007: OutcomesFES Cycling (RT300)

Passive Cycling (RT100)

1 2 3 4Age 7 9 7 11Sex F F M MLevel of injury

T4-6 C7 T3 C7

AIS A A A ATime 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 DecreasedLDL Increased Increased Increased Decreasedtriglycerides Increased Increased Decreased No changeResting HR Decreased Decreased Decreased DecreasedPeak VO2 Increased No change Not tested IncreasedPeak HR Decreased No change Increased No changeAshworth score

No change (subjective reports of decrease)

No change Decreased No change

49

Johnston et al. 2007: Results

Adherence to the training program > 90%Children will perform this form of exerciseAt 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%)

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Johnston et al. 2007: ResultsThe child with paraplegia who performed

training on the FES cycle demonstrated:A decline in resting and peak heart rateAn 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

51



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

52



Repeated Measures Arnold et al. 1992

Studied the safety and efficacy of FES cycling2 persons with either acute or chronic,

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

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Arnold et al. 1992: Intervention

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 (2.5 months) Outcomes (2.5 months) Outcomes (6 months)

54



Arnold et al. 1992: Outcome Measures

Pulmonary function was assessedApproximately 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

55



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 phasesNo change in the non-stimulated the calf muscles

56



Arnold et al. 1992: Resultscontinued

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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Pre-Post Testing

Two 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

58



Faghri et al. 1992

Effects 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 minutesWhen capable of completing three consecutive 30 minute

sessions, resistance was increased by 6.1 watts

59



Faghri et al. 1992: Outcome Measures

Collected 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.



Faghri et al. 1992: Results



Tetraplegia Paraplegia

RestSubmax

ExsRest 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

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 cyclingPersons 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

62



Faghri et al. 1992: ResultsBoth 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 SVDecreases in all vascular variables at rest post-trainingSuggests that persons with different levels of injury (namely

tetra-versus paraplegia) respond differently during exercise

63



Hooker et al. 1992

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 SCITraining similar to Faghri et al.

64



65



Hooker et al. 1992: Outcome Measures

VO2VEVCO2RER (VCO2/

VO2)SVCO

HRMAPTPRData was analyzed for

persons with paraplegia and tetraplegia together

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 trainingThe most rapid change in power output was seen during

the first 4 weeks of trainingSignificant increase in power output seen between pre- and

post-testing with the FES cycle stress testNo change in power output for the upper extremity stress test

66



Hooker et al. 1992: ResultsSignificant 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 togetherResponses have been shown to vary based on level of

injuryNo significant changes in any variables during

the upper extremity stress test

67



Zbogar et al. 2008

Studied the effects of FES cycling on arterial compliance

4 femalesChronic, 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

68



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 trainingLarge and small arterial compliance using an

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

69



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

70



Testing only (no training)

Two studies evaluated acute responses, did not involve participant trainingTheisen et al. (2002) studied the effects of 40 minutes of

cycling on power output in Five adults (4 males, 1 female) with complete (AIS A), Chronic

(>1 year) 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

71


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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:VO2

VCO2

VE

HRData were averaged over 30 second periods

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Theisen et al. 2008: ResultsStrong 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



Fornusek et al. 2008



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

Fornusek et al. 2008: Results

75



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

Summary: Descriptive Studies

Children and adults with acute or 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 paraplegia

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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 Studiescontinued

Exercising 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 cadencesPassive 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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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

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Conclusions continued Based on Systematic Review

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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Conclusions continuedBased 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

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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

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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

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Final recommendations related to training with FES cycling: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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Special thanks to Kathy Kreger and Casey Riley for their assistance in editing this document

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