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 Group
 Leadership team: Lesley Hudson, MS; David Apple, MD;
Deborah Backus, PhD, PT
 Health-related Reviewers:
 Jennith Bernstein, PT
 Amanda Gillot, PT
 Ashley Kim, PT
 Elizabeth Sasso, PT
 Kristen Casperson, PT
 Brian Smith, PT
 Anna Berry, PT
 Angela Cooke, RN
 Data coordinator: Rebecca Acevedo
2
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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, PrePost and Correlational Human Subjects” (Rogers, Farkas,
Anthony & Kash, 2008) and “Standards for Rating the
Meaning of Disability Research” (Farkas & Anthony, 2008).
3
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Table of contents
4
 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
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Translating the Evidence
Question:
Are people with SCI at risk for poor health and wellness?
Why and in what way?
5
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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
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Longevity Poses Health-Related
Problems
 Increased risk of same problems in the general population
 Cardiovascular disease (CVD) is the leading cause of death in the
able-bodied American population
 Accounted for 36.3% (871,517) of all 2,398,000 deaths in the United
States in 2004 (Rosamond et al, 2007)
7
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General Risk Factor
Exacerbated in SCI
Obesity
**
Lipid disorders
**
Heredity
Risk factors
associated with
CVD
Male
Advanced age
cigarette smoking
**
High Blood Pressure
8
Diabetes
**
Lack of physical activity
**
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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
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Increased Risk of Mortality
•
•
•
10
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
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Translating Evidence
Question:
Do interventions using functional electrical
stimulation cycles or locomotor devices
improve variables related to health in people
with SCI?
11
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Potential Interventions
 Body-weight supported treadmill training (aka BWSTT)
 Electrical Stimulation Interventions
 Surface functional electrical stimulation (FES)
 FES cycling (upper and lower limb)
12
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FES Cycling
ERGYS Muscle Power
Therapeutic Technologies
Inc., Alpha, Ohio
Restorative Therapies,
Baltimore, MD
 Surface stimulation provided to bilateral gluteal, quadriceps and





13
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
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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
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Summary of participants
 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 and females
15
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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.
16
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Summary: Research Design
 Experimental approach
 Quasi-experimental approach
 Descriptive
17
n=2
n=1
n=7
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Summary: Outcome Measures
Outcome Measures
Other
Cardio/
Resp
Muscular
Metabolic
Arnold et al. 1992
X
X
X
Bhambhani et al. 2000
X
X
Demchak et al. 2005
18
ave weekly
power output
X
Faghri, Glaser, Faghri
1992
X
Fornusek & Davis et al.
2008
X
Hooker et al. 1992
X
Johnston et al. 2007
X
Johnston et al. 2009
X
Theisen et al. 2002
X
Zbogar et al. 2008
Vascular
Power output
X
X
X
X
X
Power output
Lipid levels,
BMD
Lipids,
cholesterol
Power output
X
Experimental Design
19
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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)
20
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FES Cycling Parameters of RCT
Conditioning
Demchak
et al. 2005
Johnston et
al. 2007
21
Cycling
perform 30
reps of knee
ext with estim Began at 2
and 1 kg
watts;
weight or able
50rpm
to cycle with
2.4 watts
Lower
extremity
stretching
prior to
cycling
At home;
50rpm
Additional info
or training
Device(s)
used
Stimulation
parameters
Freq
Duration
Increased
every 3, 30
min sessions
by 6.1 watts
Stimaster
Clinical
Ergometry
system
2 watts;
max stim
140 mA
30 mins/day;
3 days/week
13 weeks
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 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
22
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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 postSCI, 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.
23
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Demchak et al 2005: Results
 Power Output
 All 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)
24
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Demchak et al 2005:
Results
continued
 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.
25
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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 fibers
 The clinical meaningfulness of the change seen here (171%) is not yet
known
26
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Johnston et al. 2009
 First randomized control 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 & 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 3 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
27
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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
28
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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-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
29
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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
30
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Summary: 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
31
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Summary: Experimental Studies
continued
 FES cycling may be a safe intervention, in children with
chronic, complete SCI and can lead to cardiorespiratory
benefits, which may improve health in these children
 Although these parameters were not studied in adults, it is likely
that they will have similar benefits with FES cycling, however, this
requires further study
32
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Quasi-Experimental Design
33
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Bhambhani et al. 2000
 n= 1
 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)
34
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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)
35
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Bhambhani et al. 2000: Results
SCI
Able-bodied
Exs
Amount
change
Exs
VO2
#
2X

VE
*#
3X

HR
#
*

RER
1.10
Max exercise
>1.10
Oxygenation
No initial increase, immediate decline,
remained stable, during recovery, increase
throughout 4 mins
Rate of decline in tissue absorbency/unit
change in VO2 faster than in AB
Amount
change
Linear
changeN
Linear
change
Linear
change
Max exercise
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
36
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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 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.
37
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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
38
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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 SCI
 Similar 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 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
39
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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 injured
 Exercise programs for persons with SCI need to be designed to
address their specific needs
40
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Summary: 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
41
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Summary: 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.
42
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Summary: Experimental &
Quasi-Experimental Studies
Methodological Considerations
 Each study addressed different health-related problems in
persons with different levels, chronicity and completeness
of SCI
 Difficult to draw conclusions for the general SCI population
 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
43
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Summary: Experimental &
Quasi-Experimental Studies
Methodological Considerations
 A study that explores the effects related to the same set of
health-related variables across the continuum of recovery
(acute and chronic), or in a single session at different
points along the continuum, will yield more useful results
and allow better decision making related to the use of FES
cycling for persons with SCI
44
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Descriptive Study Design
45
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Descriptive studies
 Case studies/reports (n=1)
 Repeated measures (n=1)
 Pre-Post test (n=5)
46
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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
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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
48
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Johnston et al. 2007: Outcomes
FES Cycling (RT300)
1
49
Passive Cycling (RT100)
2
3
4
Age
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
HDL
Increased
Increased
Decreased
Increased
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
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%)
50
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Johnston et al. 2007: Results
 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
51
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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
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Repeated Measures
Arnold et al. 1992
 Studied the safety and efficacy of FES cycling
 2 persons with either acute or chronic, complete (n=9) or
incomplete (n=1)
53
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Arnold et al. 1992: Intervention
Timeline representing the phases of training for the study
_________________________________________
Phase 1
Estim leg extension
Goal: 45 leg ext with 5lb
1 wk – 4 months
Outcomes (2.5 months)
54
Phase 2
Phase 3
FES cycling 30 minutes
30 minutes at 50rpm
1 month – 4 months
Outcomes (2.5 months)
FES cycle with resistance
Increase by 1/8Kp
No limit
Outcomes (6 months)
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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
55
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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
56
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Arnold et al. 1992: Results
continued
 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
57
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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 systems
 Faghri et al 1992, Hooker et al. 1992
 Both studied the cardiorespiratory and vascular effects in a
similar participant population
 Predominantly male adults
 Complete (AIS A) or incomplete (AIS B, C, D)
 Paraplegia or tetraplegia
 Hooker et al. (1992) included persons with acute or chronic SCI
 Faghri et al. (1992) only included those with chronic injury
58
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Faghri et al. 1992
 Effects of FES cycling on cardiorespiratory and vascular
responses
 13 persons with motor complete (AIS A or B) or motor incomplete (AIS
C or D) chronic SCI (tetraplegia(n)=7, paraplegia(n)=6)
 NOTE: The degree of completeness was determined by the Frankel
scale (American Spinal Injury Association, 1990)
 Training:
 All participants completed 36, 30-minute sessions of training in an
average of 13 weeks
 If participants became fatigued during a session, then they were
allowed to have three attempts to complete the 30 minutes
 When capable of completing three consecutive 30 minute sessions,
resistance was increased by 6.1 watts
59
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Faghri et al. 1992:
Outcome Measures
 Collected before and after the 36 sessions
 Included metabolic and cardiorespiratory testing
 At rest and during 5 minutes of FES cycling at 0-W power output
 Measures:
 VO2
 VCO2
 VE
 RER
 SV
 Cardiac output
 HR
 DBP and SBP
 Mean arterial pressure (MAP)
 Total peripheral resistance (TPR) were then calculated.
60
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Faghri et al. 1992: Results
Tetraplegia
* p<0.05
61
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
*
*
*
*
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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
62
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Faghri et al. 1992: Results
 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
63
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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 SCI
 Training similar to Faghri et al.
64
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Hooker et al. 1992:
Outcome Measures
 VO2
 HR
 VE
 MAP
 VCO2
 TPR
 RER (VCO2/ VO2)
 Data was analyzed for persons
 SV
 CO
65
with paraplegia and tetraplegia
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Hooker et al. 1992: Results
 Their findings were essentially the same as those from the
study reported by Faghri et al (1992)
 All participants were able to increase power output over the time of
FES cycle training
 The most rapid change in power output was seen during the first 4
weeks of training
 Significant increase in power output seen between pre- and post-testing with
the FES cycle stress test
 No change in power output for the upper extremity stress test
66
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Hooker et al. 1992: Results
 Significant increase in power output, VO2, VE, and HR
during the post-training on the FES cycle stress test, as
well as a lowered TPR
 No significant changes in peak SV, MAP or RER
 The lack of change may be due to analyzing the data from persons
with tetraplegia and those with paraplegia together
 Responses have been shown to vary based on level of injury
 No significant changes in any variables during the upper
extremity stress test
67
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Zbogar et al. 2008
 Studied the effects of FES cycling on arterial compliance
 4 females
 Chronic, tetraplegia (n=2, AIS B, C4 and C5) and paraplegia (n=2,
T4, AIS A and T7, AIS C)
 Training on an ERGYS 2 (Therapeutic Alliances Inc, Ohio,
USA)
 Each participant first habituated on the FES cycle so that they
were all able to train for 30 consecutive minutes
 Then trained for 30 minutes
 Average 1.9 days a week, for 12 weeks
68
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Zbogar et al. 2008:
Outcome Measures
 Collected 2 to 7 days after completion of the habituation
period
 Also 2 to 7 days after completion of the training
 Large and small arterial compliance using an applanation
tonometer (Hypertension Diagnostics/Pulse Wave CR-3000;
Eagan, MN, USA)
69
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Zbogar et al. 2008: Results
 Initial values for small arterial compliance were 53% less
than age and sex matched historical controls
 Initial values for large arterial compliance was within normal
values
 No significant change in large arterial compliance after
training
 average change was only 5% across the group
 Significant increase in small arterial compliance (p<0.05)
 Significant increase (p=0.05) of 63% from starting values
 To about 88% of normal values
 Suggest vascular effects from training on an FES cycle in
women with chronic sensory and motor incomplete SCI
70
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Testing only (no training)
 Two studies evaluated acute responses, did not involve
participant training
 Theisen 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
cadences
 AIS A
 Paraplegia
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Theisen et al. 1992
 Seated on the ergometer, they rested 10 minutes, then
started cycling with a motor at 50rpm
 Stimulation was triggered after the first 5-10 revolutions of the crank,
and increased to 120-140mA
 After this point, stimulation amplitude remained constant
 Throughout cycling collected:
 VO2
 VCO2
 VE
 HR
 Data were averaged over 30 second periods
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Theisen et al. 2008: Results
 Strong time-dependent response
 PO
 Reached maximal level at 6 minutes of exercise
 After 6 mins, power output dropped
 Progressively increased after 19.5 minutes of cycling
 Towards the end of exercise, the power output again decreased
slightly.
 VO2
 Also increased significantly from rest after 2 and 6 minutes of cycling
 Decreased again at 40 minutes of cycling
 HR
 Decreased initially but then increased to a value significantly higher
than the resting value
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Fornusek et al. 2008
 Participants performed an exercise test 1X/week for 3
weeks
 Order of testing was randomly controlled for the cadence
being tested
 15, 30, or 50rpm
 Outcome measures
 Cardiorespiratory responses
 Muscle oxygenation was measured NIRS
 Collected throughout the exercise session
 Each exercise test session lasted 35 minutes
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Fornusek et al. 2008: Results
15rpm
30rpm
50rpm
Power output
6.3+/-0.6
8.2+/-0.7
7.9+/-0.5
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. *
Passive
No change from rest
*p<0.05
Although the power output differed at the three different cadences, there were
no significant differences in the variables measured between the cadences.
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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 responses
 Persons with tetraplegia may have more autonomic disruption that
may impact their exercise response
 Exercise programs designed for persons with tetraplegia may need
to be different or modified from those with paraplegia
76
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Summary of Descriptive Studies
continued
 Exercising at different cadences may not impact power
output and acute responses to exercise
 Remains unclear what the impact would be with training for longer
duration at the different cadences
 Passive cycling may lead to cardiorespiratory benefits in
some persons with SCI
 Future study should include a careful comparison between passive
and FES cycling in persons with SCI
 The cost of these two devices is different (i.e., passive cycles are less
expensive), and if certain persons can obtain the desired health-related
benefits with a less expensive tool or device, this would be desirable
77
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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 T11
 Adults & children with incomplete tetraplegia or paraplegia between C4
and T11
 Adults with acute or chronic SCI
 Children with chronic SCI
78
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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
79
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Conclusions
continued
Based on Systematic Review
 The changes in cardiorespiratory, vascular and muscle
function are meaningful
 May lead to a decrease in the risk factors associated with CVD
 May increase longevity after SCI
 May lead to greater health and quality of life in persons with SCI
80
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Conclusions
continued
Based on Systematic Review
 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
81
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Conclusions
continued
Based on Systematic Review
 Considerations for future study:
 Variable responses in vascular responses and lipid profiles require
further study
 FES cycling and passive cycling have not been compared in relation to
the exercise and health-related benefits
 Include cost-benefit analyses to allow persons with SCI, and their payers, to make
well-informed choices about which intervention would be most productive and costefficient for that person
82
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Conclusions
continued
Based on Systematic Review
 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.
83
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Thank you!
 National Institute on Disability and
Rehabilitation Research
 Shepherd Center










Lesley Hudson, MS
David Apple, MD
Jennith Bernstein, PT
Amanda Gillot, PT
Ashley Kim, PT
Elizabeth Sasso, PT
Kristen Casperson, PT
Brian Smith, PT
Anna Berry, PT
Angela Cooke, RN
Special thanks to Kathy Kreger and Casey
Riley for their assistance in editing this
document
84
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