PLEASE FOCUS AND MENTION the actual methods used within the study ARTICLE itself.
You will prepare a 2 page report evaluating the DESCRIPTIVE statistics (points of central tendency, amount of variability, and the extent to which different variables are associated with one another) of THE ARTICLE GIVEN…..as it applies to answering the research question(s) and hypothes(es) related to the study.
Be sure to include specific examples from the course readings to support your points and to cite all references in proper APA style AND ALPHABETICAL ORDER.
PLEASE USE THE ARTICLE BELOW-
Clinical Rehabilitation 2008; 22: 987–996
How much do the benefits cost? Effects of a home-based
training programme on cardiovascular fitness, quality of
life, programme cost and adherence for patients with
Xiomara Miranda Salvetti, Japy Angelini Oliveira Filho, Denise Maria Servantes and Angelo Amato Vincenzo de
Paola Department of Cardiology, Sa%u02DC o Paulo Federal University, Paulista School of Medicine, Sa%u02DCo Paulo, Brazil
Received 10th May 2007; returned for revisions 24th June 2007; revised manuscript accepted 28th August 2007.
Objective: To evaluate cost, adherence and effects on cardiovascular function and
quality of life of a home-based cardiac rehabilitation programme for patients with
Design: A randomized, prospective controlled trial.
Setting: Department of Rehabilitation, University Hospital, Brazil.
Subjects: Thirty-nine low-risk patients were assigned to a home exercise training
group (nј19) or a control group (nј20).
Interventions: The home group performed home-based training for three months
with biweekly telephone monitoring.
Main outcome measures: The aerobic capacity and the quality of life (Medical
Outcomes Study 36-Item Short Form Survey (SF-36)) of all patients were evaluated
before and after the three-month period. Adherence was evaluated weekly.
Programme cost was estimated using the Brazilian Classification of Medical
Results: After training, the home group had higher peak Vo2 from 28.8 (6.4) to 31.7
(8.1) mL/kg per minute, peak heart rate from 135 (22) to 143 (20) bpm, work rate from
4780 (2021) to 7103 (3057) kpm/min and exercise time from 11.5 (1.9) to 13.6 (2.3)
minutes (P0.05). The control group showed reduction in peak Vo2 from 28.6 (6.6) to
26.8 (7.2) mL/kg per minute, peak Vo2 pulse from 15.5 (3.9) to 14.3 (3.8) mL/bpm and
exercise time from 11.5 (2.3) to 11.4 (2.7) minutes (P0.05). The home group
reported improvements in all domains of SF-36. The control group showed
improvement in only three domains of SF-36. In the home group the average cost per
patient was US$502.71 and the adherence achieved 100%.
Conclusion: The programme seems to provide an efficient low-cost approach to
cardiac rehabilitation in low-risk patients.
Cardiac rehabilitation programmes can promote
decrease in cardiovascular risk, morbidity, mortality,
and they can also bring economic benefits.1
Address for correspondence: Xiomara Miranda Salvetti.
Sa%u02DCo Paulo Federal University, Rua Napolea%u02DCo de Barros, 715,
Sa%u02DCo Paulo, Capital, CEP 04024-002, Brazil.
SAGE Publications 2008
Los Angeles, London, New Delhi and Singapore 10.1177/0269215508093331
However, these benefits are dependent on programme
participation and long-term adherence
to exercise. Unfortunately, less than 25% of eligible
candidates for cardiac rehabilitation actually
participate in formal programmes.2 Of those who
participate 30–40% drop out within six months
and up to 50% within a year.3
Previous studies have investigated home-based
training as an option for improving the access to
exercise training. Their results have found no differences
in exercise performance between institutional
and home-based groups measured in
various ways.4–6 Moreover, the protocols used in
the home-based programmes are very heterogeneous
and in these studies patients were exposed
to a run-in period of supervised, institutionalbased
exercise before randomization. Typically
the time used for the run-in period was three
months. Thus, we could not determine the relative
contributions of this period to the outcome. A
recent retrospective review has reported improvements
in peak Vo2 and peak work rate in both
supervised and unsupervised groups.7
Despite the fact that the evidence suggests that
cardiac rehabilitation may contribute to improved
quality of life, few studies of home-based programmes
have assessed quality of life.1,6,8
Another point merits consideration. All studies
elucidate the efficacy of exercise training under
ideal conditions, such as telephone electrocardiogram
transmission, use of portable heart rate
monitor, home support by physiotherapist or
nurse; these are rarely available for all communities.
5–7 When compared with other postmyocardial
infarction treatment interventions, cardiac
rehabilitation is more cost-effective than thrombolytic
therapy, coronary bypass surgery and
cholesterol-lowering drugs.9 However, no randomized
trials have evaluated the cost of an unsupervised
programme. To our knowledge, this is the
first study in which cardiac rehabilitation has
been designed to be easily reproducible in a wide
variety of community locations and continued in
the participants’ own environments with minimal
cost and equipment. The purpose of this study was
to evaluate the effects of a home-based training on
cardiovascular fitness, quality of life, adherence
and programme cost in low-risk patients with coronary
Patients were recruited between August 2003
and June 2005, referred from the cardiology
clinic of a large university medical centre for an
experimental protocol to phase III cardiac rehabilitation
after a coronary event.
As this was an initial protocol in our institution
and, also in our country, we decided to be very
rigorous in the selection of patients, in order to
avoid legal and ethical issues. Patients were eligible
to participate in this study if they: (1) were less
than 70 year old; (2) had current residence in
Sa%u02DCo Paulo, in order to reduce the drop-out
levels; (3) had New York Heart Association class
I or II (patients suffered no symptoms from
ordinary activities or they were confortable at
rest or with mild exertion)10; (4) had maximal
functional capacity 46 metabolic equivalents11;
(5) had normal response to exercise testing;
(6) had documented ejection fraction 450% by
echocardiogram; (7) had absence of congestive
heart failure, recurrent angina, complex ventricular
arrhythmias (multiform or consecutive ventricular
premature complexes), advanced coronary
artery disease, antecedents of cardiac arrest or
two or more myocardial infarctions.
Patients were excluded due to: (1) peripheral
vascular disease; (2) chronic obstructive pulmonary
disease; (3) limiting orthopedic abnormalities;
(4) stroke; (5) intercurrent limiting non-cardiac illness;
(6) impossibility of attending exercise training
three times per week.
This was a prospective, randomized controlled
trial. The study coordinator randomly assigned
patients to groups using a concealed randomization
process. A researcher, who did not participate
in this study, prepared the randomization schedule
using a blocked format. The resulting group
988 XM Salvetti et al.
assignments were then sealed in opaque envelopes
that were opened after consent and baseline data
were obtained. Patients could not be blinded to
their group assignment.
Thus, patients were assigned to (1) an individualized
home exercise programme (home group) or
(2) a standard care group (control group). All
study outcomes were measured at baseline and
after three months. The trial flowchart is shown
in Figure 1.
Cardiovascular outcomes: (1) peak heart rate
(bpm), (2) heart rate reserve (%), (3) rate–pressure
product (bpm.mmHg), (4) ventilatory threshold
(mL/kg per minute), (5) peak Vo2 (mL/kg per
minute), (6) peak O2 pulse (mL/bpm), (7) peak
expiratory exchange ratio, (8) work rate (kpm/
min) and (9) treadmill exercise time (minutes)
were evaluated by symptom-limited, cardiopulmonary
exercise test.12 Direct measurement of
oxygen uptake was made at the same time using
a Vista CX VACUMED metabolic cart (Ventura,
CA, USA), using a modified Bruce protocol. The
system was calibrated before each test. Peak
oxygen uptake was defined as the highest oxygen
uptake level achieved during the treadmill test.
The first ventilatory threshold was independently
identified by two investigators trained in the technique
and determined by the equivalent method.12
Blood pressure was assessed at rest and at the end
of each stage. Heart rate and 12-lead electrocardiogram
were measured continuously through the test.
Blood pressure was measured using a mercury
sphygmomanometer (Oxygel, Sa%u02DCo Paulo, Brazil),
and 12-lead electrocardiograms were obtained
with an APEX 2000 TEB Electrocardiograph (Sa%u02DCo
Paulo, SP, Brazil). The protocol and the staff for
cardiopulmonary exercise test were consistent at
baseline and after three months.
Quality of life
This was measured using the Medical Outcomes
Study 36-Item Short Form Survey (SF-36).13 The
SF-36 consists of 36 items representing eight subscales
that cover the domains of physical functioning,
role-physical, bodily pain, general health, vitality,
social functioning, role-emotional and mental
health. Individual subscale scores were computed.
Patients were encouraged to record all exercise
sessions performed during the week. Log books
were used to monitor weekly adherence.
The programme cost was based on the Brazilian
Hierarchical Classification of Medical Procedures
(BHCMP), a guide for health care payment,
according to the Brazilian Medical Association
and the Supplementary National Health Agency,
which includes diagnostic and therapeutic procedures.
14 That guide is considered by us to be an
accurate reflection of health care costs, according
to the Economic Research Institute Foundation of
the Sa%u02DCo Paulo University.14
The cost analysis of the training was estimated
in the intervention protocol, which included: (1)
initial evaluation with a doctor visit, and complementary
exams – electrocardiogram, blood lipid
profile, glucose level, cardiopulmonary exercise
test, chest X-ray and echocardiogram; (2) two
supervised exercise classes led by a physiotherapist
under medical supervision, without ECG monitoring;
(3) follow-up comprising (a) a doctor’s visit
with electrocardiogram monthly for three months;
(b) phone calls biweekly; (c) cardiopulmonary
exercise test in the third month.
The study complied with the Declaration of
Helsinki. The Joint Research Ethics Board of
Sa%u02DCo Paulo Federal University approved this study.
Patients assigned to the home group attended
two classes in a gymnasium on the university
campus. Classes were led by a physiotherapist
under medical supervision. Exercise sessions
included a 10-minute warm-up consisting of walking
and stretching exercises, 40 minutes of aerobic
Home-based training in coronary disease 989
39 patients met inclusion
n = 20
220 patients were assessed for
Cardiopulmonary exercise test
Quality of life assessment – SF-36
n = 19
2 supervised exercise classes
3-month unsupervised exercise
Biweekly telephone calls
Did not receive intervention
Excluded (n = 161):
Cardiovascular disease n= 89–55%
Non-cardiac disease n = 26–16%
Social, economic or cultural limitations:
n = 36–23%
Other conditions n = 10–6%
Declined to participate (n = 20)
Hospital clinical evaluation
n = 19
n = 20
Figure 1 Flowchart for the study.
990 XM Salvetti et al.
exercise training consisting of walking and a 10-
minute cool-down period. Exercise prescriptions
after the cardiopulmonary exercise test were
based on target intensity of 60–80% of peak
heart rate. Exercise heart rate was monitored by
palpation or by personal heart monitor (Polar,
Finland). Perceived exertion was used to determine
exercise tolerance using the Borg Ratings of
Perceived Exertion scale.15 Blood pressure was
measured before and after training. The final
15 minutes were devoted to education regarding
exercise and coronary risk factors. After two supervised
exercise classes, patients were submitted to
individualized training. The out-of-class training
included standard stretching exercises, walking
three times per week for 30 minutes on nonconsecutive
days for three months, at the assessed
target heart rate, except in warm-up and cooldown.
In addition to these instructions, patients
were given an exercise log with: (1) illustrations
of the warm-up and the cool-down exercises, (2)
a questionnaire about the presence of symptoms
during exercise, (3) the frequency of exercise to
be completed weekly. A detailed description of
the log has been published previously.16
Home patients were telephoned every two weeks
by the doctor to monitor progress, assess adherence
and provide support. Home patients and
exercise logs were reviewed monthly by a doctor
in our institution. At the three-month discharge
visit, home group patients were encouraged to
continue with their exercise regimen on their own
as a maintenance programme.
The control group was encouraged to improve
physical activity, and no active intervention was
performed. They returned to the hospital after
three months for the final cardiopulmonary exercise
test and quality of life evaluation.
The quantitative variables were given as
meanSD. The qualitative variables were
expressed by absolute frequency (n). The following
tests were used: (1) Student’s t-test for non-related
samples, to compare the quantitative variables of
the baseline clinical characteristics in both groups;
(2) Fischer test to compare the qualitative variables
of the baseline clinical characteristics in
both groups; (3) the repeated measure analysis of
variance (ANOVA) and the Bonferroni test to
compare the behaviour of the data groups over
time. A P-value less than 0.05 was considered statistically
During this study, 220 patients were evaluated.
From those subjects, 161 were considered ineligible
because they met one or more exclusion criteria,
and 20 people declined to participate. A total
of 39 patients were included in the study (19 home
group; 20 control group).
Both groups had similar medical histories and
sociodemographic characteristics (Tables 1 and 2).
As shown in Table 3, the baseline and the threemonth
exercise tests achieved the maximal respiratory
exchange ratio of about 1.1, in both groups,
without significant differences between them
(PјNS). Those data suggest that both groups performed
the maximal effort during the exercise testing.
After three months the home group
demonstrated significant improvement in peak
Vo2, peak heart rate, heart rate reserve, work rate
and treadmill exercise time (P50.05), and positive
effect in blood pressure, with decrease in resting
systolic blood pressure (P50.05). In the control
group peak Vo2, peak Vo2 pulse and treadmill
exercise time decreased after three months. The
anaerobic threshold remained unchanged in both
Quality of life
Changes in quality of life are shown in Table 4.
The home group had significant improvements in
Home-based training in coronary disease 991
all domains of the SF-36. However, the control
group showed improvement in only three of the
eight domains and decline in the other five
domains (Table 4).
The average total adherence was high (100%).
According to patient reports, registered in the log
books, the home group patients had a mean
number of 2.8 (0.4) sessions per week. Those
data agreed with the phone call monitoring. We
did not attempt to quantify the physical activity
habits of the control group for fear it would influence
their exercise behaviour.
The average patient cost is reported in Table 5.
No training-related cardiac events occurred
in the home group. In both groups there were no
coronary events during the experimental period.
This study demonstrated two important findings.
First, our cardiac rehabilitation format, designed
to be easily reproducible in a wide variety of community
locations with minimal cost and equipment,
resulted in improvement in exercise
performance with increasing in peak Vo2, peak
heart rate, heart rate reserve, work rate and treadmill
exercise time. Second, our programme
resulted in improvement in quality of life, and
registered high adherence and low costs.
Our findings were consistent with those of
Brubaker et al. and Carlson et al.,4,5 who found
that patients in home-based programmes showed
improvements in exercise capacity. Those improvements
are similar to those of subjects exercising
in hospital programmes.4,5
Our home group attained a 10% increase in
peak Vo2 after a three-month training, as described
in other studies.17 In addition, a possible
explanation for this value is that our patients
had high baseline exercise capacity (48 metabolic
equivalents). As expected, greater postconditioning
increases are typically found in unfit
patients.1,2 In addition, the decrease in peak Vo2,
peak O2 pulse, treadmill exercise time in the
Table 1 Baseline characteristics of participants in the home
group and in the control group
Age (years)b 53 (8) 54 (9) 0.765
BMI (kg/m2)b 27 (4) 27 (3) 0.776
EF (%)b 62 (7) 62 (8) 0.989
Male 14 (74%) 15 (75%)
Female 5 (26%) 5 (25%)
First school diploma 17 (89%) 18 (90%) 0.785
Medical history 0.535
15 (79%) 15 (75%)
Angioplasty 4 (21%) 5 (25%)
Coronary risk factors
Hypertension 12 (63%) 14 (70%) 0.455
Diabetes type 2 3 (16%) 4 (20%) 0.531
Dislipidaemia 14 (74%) 14 (70%) 0.540
aDifference between the home group and the control group.
bMean (SD) reported.
BMI, Body mass index; EF, ejection fraction.
The cardiovascular medication use was similar in both groups
at baseline (Table 2).
Table 2 Cardiovascular medication use at baseline in the
home group and the control group
Medication Home group Control group P-valuea
Beta blocker 15 (79%) 16 (80%) 0.622
ACE inhibitors 14 (74%) 14 (70%) 0.540
Nitrates 3 (16%) 2 (10%) 0.475
Calcium antagonists 2 (11%) 2 (10%) 0.678
Aspirin 16 (84%) 14 (70%) 0.252
Statins 13 (68%) 14 (70%) 0.594
Fibrates 1 (5%) 1 (5%) 0.744
aDifference between the home group and the control group.
Beta blocker, beta-adrenergic blocking agents; ACE inhibitors,
angiotensin-converting enzyme inhibitors.
992 XM Salvetti et al.
control group after three months may reflect the
Despite an increase of 49% in total work rate
and of 18% in treadmill exercise time, the myocardial
oxygen uptake, estimated by rate–pressure
product, remained unchanged, which constitutes
a beneficial adaptation to exercise.18
Another point merits consideration. The improvement
in treadmill exercise time in the home
group and the decrease in control group. Some
classical studies had reported exercise duration as
one of the best prognostic indicators in patients
with coronary artery disease.19,20
A common activity, such as walking, might
increase patient motivation because it can be
done so easily; it is cheaper and it is less likely to
label a patient as ill. As shown in our study, patients
assigned to the home group had improvement in
Table 3 Baseline and three-month cardiovascular outcomes in the home group and the control group
Variables Home group Control group
Baseline 3-month Baseline 3-month
Peak heart rate (bpm)a 135 (22) 143 (20)* 138 (11) 134 (17)
Heart rate reserve (%)a 82 (13) 87 (12)* 85 (8) 82 (11)
Resting systolic BP (mmHg)a 133 (15) 125(12)* 132 (15) 134 (16)
Resting diastolic BP (mmHg)a 85 (7) 84 (6) 89 (7) 87 (7)
Peak systolic BP (mmHg)a 185 (17) 178 (15) 185 (21) 184 (25)
Peak diastolic BP (mmHg)a 91 (9) 85 (5) 89 (9) 90 (7)
Rate-pressure product (bpm.mmHg)a 25 113 (5163) 25 543 (4774) 25 624 (3920) 26 240 (10099)
Ventilatory threshold (mL/kg per minute)a 21.8 (4.8) 22.8 (4.4) 21.8 (4.7) 21.2 (4.1)
Peak Vo2 (mL/kg per minute)a 28.8 (6.4) 31.7 (8.1)* 28.6 (6.6) 26.8(7.2)*
Peak O2 pulse (mL/bpm)a 15.3 (3.4) 15.7 (4.0) 15.5 (3.9) 14.3 (3.8)*
Peak expiratory exchange ratio 1.15 (0.11) 1.19 (0.08) 1.10 (0.08) 1.12 (0.11)
Work rate (kpm/min)a 4780 (2021) 7103 (3057)* 5507 (2498) 5747 (3085)
Treadmill exercise time (min)a 11.5 (1.9) 13.6 (2.3)* 11.5 (2.3) 11.4 (2.7)*
BP, blood pressure.
*Significant difference from baseline to three-month evaluation (P50.05).
aMean (SD) reported.
Table 4 Baseline and three-month quality of life in the home group and the control group according to the Medical Outcomes
Study Short-Form 36 (SF-36)13
Variable Home group Control group
Baseline 3-month Baseline 3-month
SF-36 physical functioninga 85.00 (9.86) 97.32 (2.63)* 80.50 (14.04) 78.00 (23.81)*
SF-36 role-physicala 44.00 (32.25) 93.11 (16.76)* 62.50 (39.32) 61.2 (34.86)*
SF-36 paina 71.21 (18.92) 97.68 (7.22)* 72.25 (23.47) 64.80 (17.22)*
SF-36 general healtha 65.84 (20.40) 82.63 (18.19)* 75.95 (18.13) 67.65 (14.27)*
SF-36 vitalitya 62.37 (13.68) 77.11 (10.71)* 67.00 (13.61) 57.65(12.76)*
SF-36 social functioninga 78.29 (23.51) 98.03 (6.27)* 80.00 (23.08) 81.25(20.48)*
SF-36 role-emotionala 47.40 (42.06) 94.74 (12.49)* 53.33 (41.04) 60.00(33.51)*
SF-36 mental healtha 55.26 (17.27) 71.79 (16.03)* 55.00(16.31) 64.30 (13.11)*
SF-36, Medical Outcomes Study Short-Form 36.
*Significant difference from baseline (P50.001).
aMean (SD) reported.
Home-based training in coronary disease 993
all domains of quality of life. In addition, we speculate
that the regular physical activity proposed by
the home programme, with increase in physical
conditioning, may explain the improvement in
quality of life.
On the other hand, in the control group the
improvement in the emotional, mental health
and social functioning domains may reflect the
spontaneous improvement in patient health perception,
due to the security resulting from the
results of the initial evaluation at the moment of
inclusion in the protocol. The decline in other
domains may reflect a deterioration in aerobic
Studies have indicated that convenience factors
such as distance to the cardiac rehabilitation
centre and patient-friendly schedules are important
to their participation.21,22 The home group
demonstrated high rates of participation and exercise
adherence. The potential reasons for that may
have been attributed to the greater flexibility in
our programme, and the emphasis on promoting
We also speculate that biweekly calls to each
patient in the home group contribute to the positive
outcomes in exercise capacity, quality of life
and adherence. Support provided via telephone by
the doctor may have helped patients feel connected
to the health care system. Wasson et al.
reported that frequent telephone contact may
achieve a better medical status and medical outcomes
for patients than follow-up visits alone,
reducing inpatient and outpatient medical care
Safety of the exercise training in patients with
coronary disease is related to the intensity, the
duration of training and the patient selection.24
The exclusion of patients with heart failure,
unstable angina and other limiting conditions
probably accounts for the absence of cardiac
events in this study.
A major rationale for supervised training in
ischaemic heart disease is to ensure safety.24
Continuous electrocardiographic monitoring is
not required for low- to moderate-risk patients,
although it is commonly used despite its
inability to decrease cardiovascular events.5 Selfmonitoring
may suffice for low-risk patients exercising
at home. Thus our non-monitored ECG
programme seemed justified. Accordingly, there
were no adverse events in the home group.
As expected, the absence of the ECG monitoring
sessions, and the reduced staff needs were responsible
for the lower cost of our programme. Carlson
et al.5 studied a modified protocol (i.e. gradually
reduced use of the hospital-based facilities), and
found after six months that the total average
cost per patient was of $1519.00. Our results
are consistent with and extend these findings;
in our low-cost protocol we found that the cost
was of $502.71 (BHCMP) per patient for three
Being an initial protocol in our institution,
we were rigorous in the initial evaluation to risk
stratification; we included, besides the clinical evaluation,
electrocardiogram, glucose level, blood
lipid profile, chest X-ray, echocardiogram and cardiopulmonary
exercise tests. In practical daily protocols
we believe that the programme would be
made cheaper if the echocardiogram in the initial
evaluation were not included for patients with
normal cardiac area, and cardiopulmonary exercise
test were replaced by a simple exercise testing
which occurs only at the time of inclusion. This
would reduce the cost of the programme to
US$209.88 (BHCMP) for three months.
The generalizability of our findings may be
restricted because of some possible limitations. It
was not feasible to include a usual hospital-based
exercise group because that was not offered in our
Table 5 Home-based programme cost according to the
Brazilian Hierarchical Classification of Medical Procedures14
Procedure/service Cost (US$)
Doctor visit $19.30
Blood lipid profile $9.44
Glucose level $2.08
Cardiopulmonary exercise test $98.58
Chest X-ray $13.73
Two sessions without ECG monitoring $32.00
Three doctor visits $57.90
Three electrocardiograms $33.96
Cardiopulmonary exercise test $98.58
Phone call average $16.66
Total average cost per patient $502.71
994 XM Salvetti et al.
hospital. A sample of 39 patients was selected
as being feasible for initial investigation and
clearly similar studies with this protocol design
should include larger number of participants.
Also, once patients were randomized, it was not
possible to blind the physicians to the protocol to
which patients were assigned. Moreover, the small
number of women in each group precludes assessment
of gender differences. As mentioned previously
regarding the initial programme in our
institution and in our country, we followed
the orientations of the juridical consultantship
and of the joint research ethics board of our institution
in opting for a rigorous patient selection.
However, this choice resulted in a large number
of exclusions. Thus, we are beginning to apply
the programme to patients with ventricular dysfunction
and controlled heart failure. This will
allow us to assess the wider applicability of this
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Home-based training in coronary disease 995
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