A pilot randomized controlled trial to evaluate the benefit of the

Clinical Rehabilitatio n 20ffi; 2.: 125-133
A pilot randomizedcontrolledtrial to evaluatethe benefit
paradigmfor the non-acute
of the cardiacrehabilitation
ischaemicstroke population
Unit, Baggot Street Community
Olive Lennon, Aisling Garey, Niamh Gaffney, Julia Stephenson Stroke Rehabilitation
and PerformanceScience,UniversityCollegeDublin, lreland
Hospitaland Catherine Blake School of Physiotherapy
Received22nd December2006; returnedfor revisions25th February2007; revisedmanuscriptaccepted18th April 2007.
qualityof life following
Objective: To evaluaterisk factor reductionand health-related
a 10-week cardiacrehabilitationprogramme in non-acuteischaemicstroke subjects.
Des ign: S ing l e -b l i n d era
d n d o mi z e dc o n tro ltri al .
Setting: Outpatient rehabilitation.
Subjects: Forty-eightcommunity-dwellingischaemicstroke patients (38 indepenwere randomlyassignedto
dently mobile, 9 requiringassistance,1 non-ambulatory)
interventionor control groups by concealedallocation.
Intervention: The trial consistedof a 10-week schedulewith measurestaken at
week s 1 and 1 0 . Bo th g ro u p sc o n ti n u e du s ualcare (excl udi ngaerobi cexerci se);
interventionsubjects attended 16 cycle ergometry sessionsof aerobic-training
intensityand two stress-managementclasses.
Main outcome measures: Cardiacrisk score (CRS);MCz(mL Ozlkg per minute) and
Borg Rate of PerceivedExertion(RPE)assessedduring a standardizedergometry
test; HospitalAnxiety and DepressionScale(HADS);FrenchayActivity Index; Fasting
Lipid P r of ile sa n d R e s ti n gB l o o d P re s s u re .
Results: Group comparisonwith independentf-tests showed significantlygreater
improvementat follow-up by interventionsubjectsthan controlsin VOz (intervention
) n dC R S
i 0 , 6 + 1 , 6 t o 1 2 . 0 + 2 . 2 ,c o n l r o1l 1 . 1+ 1 . 8 t o 1 1 . 1+ 1 . 9 f - 4 . 7 3 4 ,P < 0 . 0 0 1 a
( i n t e r v e n t i o1n3 . 4+ 1 0 . 1 t o 12 . 4 + 1 0 . 5 ,c o n t r o l9 . 4+ 6 . 7 t o 1 5 . 0* 6 . 1 f : - 2 . 5 3 7 ,
P < 0. 05) .RPEra ti n gd e c re a s e di n i n te rv e nti onsubj ects(13.4 + 12.2 to 12.4* 2.0) and
inc r eas edin c o n tro l s(1 3 ,8+ 1 .8 Io 1 4 .4+ 1 .6);Mann-W hi tneyU (U :173.5, P < 0.05).
W it hin- gr oupc o m p a ri s o ns h o w e d s i g n i fi c antdecreasei n the H A D S depressi on
s ubs c alein t h e i n te rv e n ti o ng ro u pa l o n e(5 .1+ 3.4 to 3.0 + 2.81(W i l coxonsi gnedranks
t es t Z : - 3. 2 7 8 , P< 0 .0 0 1 ).
G onc lus ion:Pre l i mi n a ryfi n d i n g ss u g g e s t non-acutei schaemi cstroke pati entscan
fitness and reducetheir CRS with a cardiacrehabilitation
imorove their cardiovascular
programme.The interventionwas associatedwith improvement in self-reported
depr es s ion.
Address for correspondence: Olive Lennon, Stroke
Rehabilitation Unit, Baggot Street Community Hospital,
18 Upper Baggot Street,Dublin 4, Ireland.
e-mail: olive.lennonCalhse.ie
@ SAGE Publications2008
Los Angeles,London, New Delhi and Singapore
t0.tr7 7I 02692I 5507081580
126 O Lennon et al.
lntroduction
Cardiovascular disease and ischaemic stroke
are both vascular diseases sharing many
predisposing,potentially modifiable risk factors
(hypertension,abnormal blood lipids and lipoproteins, cigarette smoking. plVsical inactivity,
obesityand diabetesmellitus).''-Their association
is not benign, with the risk of death in the stroke
population, in part due to cardiac disease,at least
twice that of age-matchedcontrols.' Modification
of multiple risk factors through lifestyle interventions and pharmacologicaltherapy is recognized
as the cornerstone of prevention of recurrent
events.35
Regular physical activity and cardiac rehabilitation have proven benefits in the general
population utrd port cardiac event,6-ehJwever,
adoption of the cardiac rehabilitation paradigm
to the ischaemicstroke population has remained
untested.Stroke patients are known to have low
endurance to exercise and decreased activity
levelslOand few can avail themselvesof cardiovascular training through exercisecounsellingalone
due to acquiied olsiultity.rr A Cochrane review
and the American Stroke Association have
highlighted as a priority the need for research
into the efficacv and feasibilitv of aerobic exercises
post stroke.2'll
As adapted cycle ergometers allow aerobic
this pilot study
fitness training post strolel0'l-3'14
aims to establish the feasibility of a l0-week
cardiac rehabilitation programme including
l6 cycle ergometry sessions.Of interestis whether
the programme improves:
. Cardiovascularfitnessusing estimatedVO2 and
Borg's Rate of PerceivedExertionl5 (RPE), at a
given workload and resting heart rate (HR).
. Multivariate cardiac riik scoret6 (CRS)
measured by a coronary disease prediction
algorithm.
. Cardiovascular-metabolic risk factor profile
using fasting lipid profiles and resting blood
pressure.
. Health-related function and quality of life as
measured by the Frenchay Activity IndexlT
and the Hospital Anxiety and Depression
Scale.ls
Methods
Study design
A randomized,controlled, single-blindtrial was
conducted, approved by University College
Dublin Human Research Ethics Committee.
Measurements were made by an independent
assessorblinded to allocation.
Patients
Subjects were recruited from the Stroke
Baggot
Street
Rehabilitation
Database,
Hospital,
Dublin.
Information
Community
leafletswere posted and volunteerscontacted the
research team for initial telephone screening,
includingthe PAR-Q Questionnaire.re
Informed consent was obtained. Participants'
general practitioners were asked to notify
contraindications to exercise or medication
changes. All participants received a medical
screeningby a physician in the stroke unit prior
to participation.
Sample size calculationswith 80% power and
P<0.05 were conductedon the following outcome
measures:
.
Borg's RPE15scaleto detect a 2-point change
between groups indicated that a minimum of
16 subjects would be required per group
(mean 17 (SD z)).tu
. Hospital Anxiety and DepressionScale(HADS)
depressionsubscaleto detecta2.5-pornt change
betweengroups indicated a minimum of 24 per
g r o u p( m e a n6 . 2( S D 3 . 1 ) ) . ' '
. Systolic blood pressurereduction of 5 mmHg
indicated a minimum of 170 subjectsin each
group22which was not feasible for this pilot
study. Data for CRS in stroke patients was
not availablefor samplesizecalculation.
Inclusion criteria: >l year post ischaemicstroke
(confirmedby CT or MRI scan)and over 18 years
of age. Patients were included irrespectiveof their
ability to ambulate independently.
Exclusion criteria: 02 dependence, angina,
unstablecardiac conditions,uncontrolled diabetes
mellitus, major medical conditions, claudication,
febrile illness' cognitive impairment or beta
Pilot RTC of cardiac rehabilita:tionin stroke
127
blocker medication (RPE, a primary outcome dizziness,malaise, heart rate in excessof 60'/o
maximal heart rate, oxygen saturation levels
measure,was shown to be unreliable in subiects
lower than g0% or participant request to stop in
taking beta blocker medi cation).22'23
accordance with American Heart Association
(AHA) guidelines.2a
Random allocation
Participants were assigned an ID number,
stratified by age and sex into four blocks of six
and randomly assignedusing a sequencegenerator
(SPSS version 12.0), to either intervention or
control groups, by an independent party.
Following initial testing, participants were
handed an opaque envelope which contained
details of their group assignment,by clerical staff
unrelated to the trial.
Programme
Both control and intervention subjects who
were in receipt of physiotherapy and occupational therapy services continued with usual
care. Occupational and physiotherapy received
focused on functional activities, balance and
gait. No therapy contained an aerobic exercise
component.
Control subjectshad a baselineassessmenton
week I and re-assessment
on week l0 with no
additional intervention in the interim.
The Cardiac Rehabilitation Programme
consisted of a l0-week schedule with baseline
in week 10.
measuresin week I and reassessment
Intervention subjects attended twice weekly for
30-minute cycle ergometry exercise (Motomed
Viva 2) using either the upper or lower limbs.
They exercised through biofeedback alarms set
at 50-60o/oof their maximal heart rate, calculated sessionally (Karvonen formula THR (HR-u* - HR.otX50-60%) + HR.",,;. Resistance
and speed were adjusted daily to ensure tailored
progression.As participants did not exceed60oh
max HR, the plogramme posed very low risk of
adverse events.' Participants attended two life
skills classes addressing stress management,
relaxation and life balance.
Two participants exercised concurrently in a
controlled environment and all sessions were
supervisedby a physiotherapist.Staff had cardiac
resuscitation and defibrillation certification.
Indications to stop exerciseincluded: chest pain,
Measurements
a
Baseline descriptives includjr-rg Oxfordshire
Stroke SubtypeClassification," medicalhistory
including stroke, previous rcardiacevents and
were noted
Functional Ambulation Cal.egory26
from eachparticipant's meclicalchart.
Fitnesstestinsrewas conductedwith a standardized 3-minuie submaximal rexercise
test using a
cycle ergometer (Reck, Mr:tomed Ywa 2) at
resistancesetting 8 (5.6Nm,). Participantswere
fasting overnight for 12 h<;rursat the time of
testing, they were instruct,edto wear loose,
comfortable clothing and room temperature
was maintained at 20"C. Tht: machinepassively
rpm, allowing a
moved for I minute at 1!i0
warm-up and assuring ro joint discomfort.
Participants took over peda.llingfor 3 minutes
at a steadystate of 50rpm 'with a workload of
5.6Nm. A metronome wars present to assist
with pacing.
was calculated
VOz (mL
9zlkg/min)
(10.8x W x M ') +7, usin.gaveragewattage
output during the test.
RPE was rated at the end of the test, in
l5
accordancewith the recomnrendedguidelines.
Peak wattage was recordeil at the end of the
3-minute exercisetest.
Cardiac risk scoretu(CRS) was calculated for
each participant. This is arr algorithmic score
based on age, resting bloocl pressure,smoking
status, diabetic status, tot.al cholesterol and
high-densitylipoprotein (H.DL) scores.
Resting heart rate and SaO2 were measured
following a 5-minute st,:ated rest period
(Nanox 2 oximeter, Medlatr).
Resting brachial artery blood pressure (unaffected limb) was measuredlwith a calibrated
mercury sphygmomanometlerin accordance
with the Joint National Committ ee YI.27
Body mass index (BMI) was calculatedusing a
calibrated weighing scalesand metre rule.
128 O Lennon et al.
. Fasting lipids were measured from blood
samples obtained by venipuncture following
overnight fasting by the subjects.Serum was
analysedfor total cholesteroland triglycerides.
HDL cholesterolwas determinedfrom plasma.
Low-density lipoprotein (LDL) cholesterol
calculatedusine the Friedewaldequation.2s
. Frenchay Acti'iity IndexlT and HADSTs forms
were frlled in by all participants.
. Spirometry testing was performed with the
participant in upright sitting using the
Microlab 3300 (Micro Medical Limited).
Routine use of respiratory medications
including inhalerswas permitted.
as such final scoresare included on patients who
failed to complete the intervention.'n Change
scores were compared between groups using
independent l-tests where data were interval or
ratio level and conformed to the assumptionsof
normality. Mann-Whitney non-parametric tests
were otherwise used. Ancillary analysis included
single-group analysis using paired /-tests and
Wilcoxon signedranks test.
Results
Demographic and clinical characteristicsof the
intervention and control groups are presentedin
Table l. Forty-eight subjectsentpredthe trial with
participant flow representedin Figure 1.
No change in cholesterollowering medication
Data analysis
Data were enteredonto the StatisticalPackage was reported in either group. Three control subfor the Social Sciences(SPSS)version 12.Analysis jects had blood pressure medication changes
performed was on an intention to treat basisand during the trial: subject 4, from hypertension
Table 1
Baselineand clinicaldescriotives
Baselinedescriptives
C o n t r o l( n : 2 4 )
Mean(SD)
A c t i v el n : 2 4 1
Mean (SD)
Age (years)
Time since cerebrovascular
accident(CVA)(weeks)
6 0 . 5( 1 0 . 0 )
245.3(169.8)
59.0(10.3)
2 3 7 . 3( 1 1 0 . 7 )
Male
Female
Risht CVA
Left CVA
OxfordshireStroke SubtypeClassification
Total anteriorcirculationinfarct(TACI)
Partialanteriorcirculationinfarct(PACI)
Lacunarinfarct(LACI)
Posteriorcirculationinfarct(POCI)
Unknown
FunctionalAmbulationCategory
0
1
2
3
4
5
Known cardiachistory
lschaemicheart disease
Myocardialinfarct
Coronaryartery bypass graft
Atrial fibrillation
Recurrentstroke
n (ohl
14(58%)
10 (42V.1
11 (45o/ol
13 (54o/ol
1 (4.2o/ol
12 (50o/o)
5 Q0.?V.l
3l12.5%ol
3112.5%)
n (o/ol
14 (58%)
10 (42o/ol
13 (54Yol
11 (450/,1
3 (12.5Vo)
9 (37.5)
7 {29.20/,1
2|,8.3V,)
3'1,12.5Yo]l
1 (4.2o/ol
218.3%ol
1 14.2o/o)
1 (4.2o/ol
6 (25o/ol
13 (54.2o/ol
0 (0%)
3112.50/"1
114.2%)
1 14.2o/o)
4'!\16.7%l
15 (62.50/ol
1 (4.2Vol
1 (4.2o/ol
0 (0olo)
2 (8.3'/ol
3 (12.5Vo)
3112.5o/ol
0 (0olo)
1 (4.2o/ol
2 (8.3o/ol
4 (16.7o/o)
Pilot RTC of cardiac rehabilitation in stroke
Number of patients meeting
entry criteria: N= 145
Lettersretumed: n=3
Deceased:
n=1
Refused:
n=75
Expressedinterestn = 66
Withdrawnat initialscreening
(n= 18)
Reasons:
On holidaysduringtrial(n = 5)
On beta blockersh = 121
Unstablediabetes(n = | )
Allocatedto controlgroup(n = 24)
Allocated to intervention group (n = 24)
Received allocated interuention (n =2 3l
*Withdrawn prior
to intervention (n = 1)
'(acute
illness)
Lostto follow-up(n = 0)
Analysed(n = 231
Figure 1
Participantflow diagram.
monotherapy to angiotensin II antagonist/
thiazide, subject 12 was prescribed a diuretic
tablet the day before retesting and subject 34 had
hypertension medication increased. Of the
intervention group no change to hypertension
agents was noted. Seven of the 48 subjects
recruited to the study (3 control, 4 intervention)
continued usual therapy as described in the
programme outline.
Table 2 illustrates control and intervention
group scores demonstrated at baseline and
follow-up. Baselinescoreswere comparedbetween
groups with no significant differences noted,
despite outliers in BMI and time since stroke in
the intervention and control groups, respectively.
Outliers were included in analysis. Between-sex
differenceswere noted in baselinedata with males
scoring significantly higher on forced expiratory
volume in I second(FEVr) (P-0.005), peak wattage (P < 0.001) and total cholesterol(P - 0.02).
129
When change scores were compared between
groups, the intervention arm demonstrated
significantly greater improvements after treatment
in severalprimary variableswhen comparedwith
the control. Overall cardiovascular fitness
improved in the intervention group with greater
increasein VO2 Q 4.734,P<0.001) and decrease
in RPE (U 173.5,P-0.04) by comparisonwith
the controls. Cardiac risk score reduced in the
intervention group but increased in the controls
(t - 2.537, P - 0.015). No significant change
occurred in cardiovascular-metabolic risk factor
profiles of total cholesterol,LDL, HDL, triglycerides, systolic and diastolic blood pressures.
Similarly, no significant difference was found in
the Frenchay Activity Index or HADS change
scores.
Secondary outcome analysis demonstrated no
significant difference in change scores between
groups in spirometry results of forced vital
capacity (FVC), peak expiratory flow (PEF),
FEVr and FEVTIFVC (%). Peak wattage output
reflecting peak power generated by the limbs
during testing increasedin the intervention group
comparedto the control (t 4.035,,P<0.001).
When within-group analysis was performed
using paired /-tests and Wilcoxon signed ranks
test where appropriate, only the intervention
group had a significant change in VOz
(P<0.001) and cardiacrisk score(P-0.005). It
is interesting to note that the HADS depression
score also improved significantly in the intervention group (Z -3.278, P<0.001), but not in the
control. BMI increasedin both control (P:0.008)
and intervention(P :0.012) groups.
Between-sex
comparisonof changescoresin the
intervention arm indicates both males and
females benefited equally from the intervention
(no significant differencesnoted).
Discussion
This pilot randomizedcontrolled trial study tested
the feasibility of a 10-weekcardiac rehabilitation
programme, demonstrating its efficacy with
significant increasesin fitness parametersof VO2
and RPE and cardiac risk score reduction in the
intervention group.
130 O Lennon et aI.
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Pilot RTC of cardiac rehabilitatibn in stroke
131
No significant improvements were noted in rehabilitation in coronary heart disease8has
health-related quality of life (HRQoL) indices demonstrateda net reduction in total cholesterol
or cardiovascular-metabolicprofiles. Decreased and LDL in comprehensivecardiac rehabilitation
HADS depressionscoreson final testing in the groups but not in exercise-only interventions.
active group does however suggestan associated As both groups in this study demonstrated no
increase in well-being. As a pilot study with significant change in lipoprotein profiles
relatively small numbers, limited power to and increasesin BMI over the trial period, it
demonstrate health status and functional bene- suggests future interventions should involve
dietary education.
fits exists.
Two coronary heart disease trials33'34noted
Another limitation of the methodology
in both systolicand diastolic
employed in this study is that the control group favourabledecreases
did not receive comparable non-exerciserelated blood pressure in comprehensive cardtac
attention to the intervention group. Thus there programmes. However, systematicreview noted
an increasein blood pressure over trial periods
may be a potential Hawthorn effect.
The Cochrane Review on Physical Fitness in both groups in a number of studies.uAs
Training in Stroke Patientslt drtuils only two increases were more marked in the control
studies including measures of aerobic fitness groups, the net changeswere considerednegative.
(VO) and maximal work rate (Watts)r0'30and This study demonstrateda drop in systolic blood
two meeting the American College of Sports pressure in both groups and an increase in
Medicine (ACSM) guidelines for developing diastolic blood pressure in both groups.
15ir study complies A number of subjectsin the control group had
cardiorespiratoryfitness.t0'31
with cardiovasculartraining requirementsby the a change in hypertension medications over the
rigour of the training programme described and course of the trial but no change in medication
similar improvements in fitness parameters VOz noted in the intervention grolrp, suggesting a
and RPE were observed in this study. As no possible trend toward blood pressure reduction
aerobic training component was included in in the intervention group.
Higher cardiac risk scoresin the intervention
usual therapy, common to both groups, these
changes may be attributed to the intervention. group occurred because, despite randomization,
It has been demonstrated in the literature that the intervention arm contained three more
stroke patients can improve their fitness levels to people with diabetesthan the control. This status
the same deqree as their aee-matchedcounter- does not change from initial to final testing.
parts.r0 This"study, througli deployment of the Similarly both groups contained six smokersand
CRS outcome measure,demonstratesthe benefit 17 non-smokers,with smoking status remaining
unchanged on final testing. Therefore the cardiac
of such interventionson vascularrisk reduction.
Previous studies noted that improvement in risk reduction scoreswere as a result of alteration
RPE and VO2 cannot distinguish between central of resting blood pressureand fasting cholesterol
This was also measurements. While no significant change
and peripher-al adaptation.'10'32
observed in this study with a significant increase was seen in either variable in isolation, when
in peak wattage in the intervention group consideredin the context of a weighted algorithcompared to the control, indicating that a lower mic score, cardiac risk scoreswgre reduced in the
limb muscle training effect must be consideredas intervention group. Given the absenceof change
well as central cardiac adaptation to the exercise in cholesterollowering medicationsin both groups
programme.
and pharmacologicalmanagementof hypertension
cardiac rehabilitation in the interventiongroup, this may be attributed to
Comparison with
programmes for the coronary heart disease the programme.
The authors acknowledgethe cardiac risk score
populations is limited as primary outcome
measures of mortality and non-fatal cardiac algorithm usedis not validatedfor non-caucasians
events were not feasible in the short time-frame (subject 1; intervention group) and those over
and limited subject numbers in this pilot 74 years old (subject 13; control and subject 19;
study. However, meta-analysisof exercise-based intervention). Analysis of cardiac risk change
132 O Lennon et al.
scoreswith thesesubjects' data removed however, References
continues to demonstrate significantly greater
cardiac risk reduction in the intervention group
I Heart Health Task Force. Ireland's Changing
Heart. Department of Health and Children, 2003.
( t - 2 . 5 1 2 ,P - 0 . 0 1 6 ) .
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to be cost-effectivebut needsto be better tarseted
3 Adams RJ, Chimowitz MI, A,lpert JS e/ al. AHAI
for potential health gain.35
ASA Scientific Statement.Coronary risk evaulaNo study to date has looked at reducing
tion in patients with transient.ischemicattack and
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5 Wolf PA, Clagett GP, Easton JD et a/. Preventing
this study, sample size estimation (n>2Kotl\'
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(K:7.8)) suggestsa minimum of 120 subjects
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in a definitive studv. to be conducted bv this
6 PearsonTA, Blair SN, Daniels SR et al. AHA
researchgroup.
guidelinesfor primary prevenl.ionof cardiovascular
7
Clinical messages
. Ischaemic stroke patients have high risk
of coronary heart disease and recurrent
stroke.
. Stroke patients are known to have low exercise endurance.
o Submaximal aerobic training is both safe
and feasiblein chronic stroke using adapted
cycle ergometry.
. The cardiac rehabilitation paradigm adapted
to stroke reducescardiac risk and increases
aerobic fitness in chronic ischaemic stroke
patients.
8
9
10
II
Acknowledgementsand funding
Heart Health ResearchBursary, Health Service
Executive, Ireland 2004. Ethical approval was
granted by University College Dublin, Human 12
Research Ethics Sub-Committee, University
CollegeDublin, Belfield,Dublin 4, Ireland.
All authors state no conflict of interestexistsin
this body of research.
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