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BioMed Central
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BMC Cardiovascular Disorders
Open Access
Study protocol
Home-based exercise rehabilitation in addition to specialist heart
failure nurse care: design, rationale and recruitment to the
Birmingham Rehabilitation Uptake Maximisation study for patients
with congestive heart failure (BRUM-CHF): a randomised
controlled trial
Kate Jolly*1, Rod S Tayor2, Gregory YH Lip3, Sheila M Greenfield4,
Michael K Davies5, Russell C Davis6, Jonathan W Mant4, Sally J Singh7,
Jackie T Ingram4, Jane Stubley6 and Andrew J Stevens1
Address: 1Department of Public Health & Epidemiology, Public Health Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT,
UK, 2Peninsula Medical School, University of Exeter, EX2 5DW, UK, 3University Department of Medicine, City Hospital, Dudley Road,
Birmingham, B18 7QH, UK, 4Department of Primary Care & General Practice, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK,
5Department of Cardiology, University Hospital Birminghan NHS Trust, Birmingham, B15 2TH, UK, 6Sandwell and West Birmingham NHS Trust,
Lyndon, West Bromwich, West Midlands, B71 4HJ, UK and 7Dept Cardiac and Pulmonary Rehabilitation, University Hospitals of Leicester, UK
Email: Kate Jolly* - c.b.jolly@bham.ac.uk; Rod S Tayor - rod.taylor@pms.ac.uk; Gregory YH Lip - G.Y.H.Lip@bham.ac.uk;
Sheila M Greenfield - S.M.Greenfield@bham.ac.uk; Michael K Davies - michael.davies@uhb.nhs.uk;
Russell C Davis - Russell.davis@swbh.nhs.uk; Jonathan W Mant - J.W.mant@bham.ac.uk; Sally J Singh - S.Singh@uhl-tr.nhs.uk;
Jackie T Ingram - J.T.Ingram@bham.ac.uk; Jane Stubley - jane.stubley@swbh.nhs.uk; Andrew J Stevens - A.J.Stevens@bham.ac.uk
* Corresponding author
Abstract
Background: Exercise has been shown to be beneficial for selected patients with heart failure, but
questions remain over its effectiveness, cost-effectiveness and uptake in a real world setting. This
paper describes the design, rationale and recruitment for a randomised controlled trial that will
explore the effectiveness and uptake of a predominantly home-based exercise rehabilitation
programme, as well as its cost-effectiveness and patient acceptability.
Methods/design: Randomised controlled trial comparing specialist heart failure nurse care plus a
nurse-led predominantly home-based exercise intervention against specialist heart failure nurse
care alone in a multiethnic city population, served by two NHS Trusts and one primary care setting,
in the United Kingdom.
169 English speaking patients with stable heart failure, defined as systolic impairment (ejection
fraction ≤ 40%). with one or more hospital admissions with clinical heart failure or New York Heart
Association (NYHA) II/III within previous 24-months were recruited.
Main outcome measures at 1 year: Minnesota Living with Heart Failure Questionnaire, incremental
shuttle walk test, death or admission with heart failure or myocardial infarction, health care
utilisation and costs. Interviews with purposive samples of patients to gain qualitative information
about acceptability and adherence to exercise, views about their treatment, self-management of
their heart failure and reasons why some patients declined to participate.
Published: 7 March 2007
BMC Cardiovascular Disorders 2007, 7:9 doi:10.1186/1471-2261-7-9
Received: 29 November 2006
Accepted: 7 March 2007
This article is available from: http://www.biomedcentral.com/1471-2261/7/9
© 2007 Jolly et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9
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The records of 1639 patients managed by specialist heart failure services were screened, of which
997 (61%) were ineligible, due to ejection fraction>40%, current NYHA IV, no admission or NYHA
II or more within the previous 2 years, or serious co-morbidities preventing physical activity. 642
patients were contacted: 289 (45%) declined to participate, 183 (39%) had an exclusion criterion
and 169 (26%) agreed to randomisation.
Discussion: Due to safety considerations for home-exercise less than half of patients treated by
specialist heart failure services were eligible for the study. Many patients had co-morbidities
preventing exercise and others had concerns about undertaking an exercise programme.
Background
Heart failure is a major cause of morbidity and mortality
in westernised societies and has a poor prognosis [1-3]
Patients with heart failure (HF) suffer from a variety of
symptoms, many of which are non-specific and often
result in a poor quality of life[4], with decreased exercise
capacity being the main factor restricting daily activity.
Heart failure management in the UK is currently undergo-
ing major changes as a result of evidence showing the ben-
efits of specialist nurses in reducing hospital
readmissions[5,6] Specialist heart failure nurses funded
both by the British Heart Foundation and by local primary
care trusts are becoming part of the accepted standard of
care for patients with heart failure. Specialist heart failure
nurses do not currently provide structured exercise train-
ing[6,7].
Effectiveness of exercise rehabilitation
Four systematic reviews have addressed the effectiveness
of exercise training for patients with heart failure [8-11]. A
qualitative review in 2002 concluded that short-term exer-
cise training in selected sub-groups of patients led to
short-term improvements on quality of life and had some
physiological benefits[8]. However, it was noted that
most trials were of short duration, small scale and
focussed on physiological changes rather than morbidity
and mortality. They also had included a patient profile
that is not representative of typical heart failure patients,
being younger, predominantly male and without co-mor-
bidities[8].
A Cochrane review which included 1126 patients in 29
randomised controlled trials (RCT) concluded that for
patients with New York Heart Association (NYHA) class II
or III heart failure, exercise training improved exercise
capacity and quality of life in the short-term. Improve-
ments in exercise capacity were greater in programmes of
greater intensity and longer duration[10]. One study[11]
using an end point of combined events and mortality
found no difference in combined events (death or adverse
events) in the exercise group (OR 0.98; 95% CI 0.61 to
1.32) compared to the control group. There was a non-sig-
nificant trend towards a reduction in mortality (OR 0.71;
95% CI 0.37 to 1.02, p = 0.06)[11]. The ExTraMATCH col-
laboration undertook an individual patient data meta-
analysis by combining the datasets from eight RCTs with
a total of 801 patients[9]. This had access to longer-term
follow-up data than was available to the previous meta-
analyses and showed an overall reduction in mortality in
the patients who received the exercise intervention (haz-
ard ratio 0.65; 95% CI 0.42 to 0.92)[9].
Only one trial has compared exercise training in patients
with a control group receiving a specialist heart failure
nurse intervention[12]. This evaluated an eight-week hos-
pital rehabilitation programme including exercise and
education followed by a 16 week community supervised
exercise programme in patients referred to a specialist
heart failure nurse and reported significant improvements
at 24 week follow-up in the Minnesota Living with Heart
Failure Questionnaire (MLwHF) and EuroQol scores, the
New York Heart Association (NYHA) class and distance
walked on the 6-minute walk between the rehabilitation
and specialist heart failure nurse care only[12]. The exer-
cise intervention occurred at the same time as medication
was optimised and there was a higher proportion of
patients in the intervention arm on beta-blockade, which
may have accounted for some of the difference. In addi-
tion the rehabilitation programme included an educa-
tional component and was not solely exercise-based.
Mechanism of action of exercise
The majority of trials of exercise in patients with heart fail-
ure have reported physiological improvements, which are
mainly due to peripheral adaptations [13-18] There is
some evidence that exercise increases cardiac stroke vol-
ume[16,19-21] and reduces cardiomegaly[16]. Exercise
training has been shown to lower resting heart rate and
improve myocardial perfusion[22]. The mechanisms of
these actions include an improvement in the neurohor-
monal abnormalities seen in heart failure, enhanced vagal
tone, and changes in skeletal muscle type and function
[13]. Favourable changes in the indices of heart rate vari-
ability have been reported, which indicates improved
autonomic control of heart rate and has been associated
with improved survival[23]. However, trials of exercise
interventions rarely report data on the extent to which
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medication use changed, which would have affected the
outcomes.
Type of exercise and settings
Current recommendations for exercise training are based
on experiences from a limited number of randomised
controlled trials that have enrolled highly selected
patients. Questions remain about the optimal training
modality and intensity[24] but current evidence suggests
that training should include aerobic and resistance com-
ponents. Peripheral muscles should be trained without a
significant increase in cardiovascular stress[25], using
intermittent exercise and/or sequential training.
Whilst the National Service Framework for coronary heart
disease suggests that cardiac rehabilitation should be con-
sidered for patients with heart failure[26], it is rarely pro-
vided in the UK. Indeed, there are no published data on
the uptake and acceptability of exercise-based rehabilita-
tion for heart failure, but poor uptake post myocardial inf-
arction (MI) occurs particularly in women, the elderly and
patients from minority ethnic groups [27-31]. and the
profile of patients with heart failure is older and includes
more women than is the case for MI. Only one entirely
home-based exercise intervention trial (20 patients in
home arm) has been reported, with significant improve-
ments in quality of life compared to patients receiving
usual care[32].
Rationale for Birmingham Rehabilitation Uptake
Maximisation study for patients with congestive heart
failure (BRUM-CHF) study
Whilst there are a number of very small trials of exercise
interventions for patients with heart failure, questions
remain about the effectiveness of exercise interventions
outside specialist research units and in a representative
patient population[24]. The follow-up period needed to
be of sufficient duration to measure hospital admissions
and mortality. In addition, apart from one trial[12], the
reported trials of exercise rehabilitation were all compared
to 'usual care'. The latter provided in these control arms is
inferior to the specialist heart failure nurse intervention
now offered as part of modern heart failure management
programmes. There is also no evidence as to whether the
improvements in quality of life and mortality in the exer-
cise intervention groups in the published trials, are a result
of physiological improvements or from the close clinical
monitoring received alongside the exercise. It may also be
that lifestyle and drug management advice was imparted
with the exercise intervention and these improvements
would now result from the specialist nurse intervention.
The cost-effectiveness of exercise interventions has been
addressed by only one study[33], which had usual care as
the control group. This concluded that a long-term hospi-
tal-based exercise programme for people with stable heart
failure was a cost-effective intervention[33].
The BRUM-CHF study proposes to establish the addi-
tional benefits of exercise rehabilitation compared to cur-
rent care that includes specialist heart failure nurses.
Given the potential problems with the capacity of the hos-
pital service and uptake in a more elderly and debilitated
population than other patients receiving cardiac rehabili-
tation for MI or revascularisation, it will be important to
have information about effectiveness, uptake and compli-
ance in a predominantly home-based setting.
Study aim
The primary research question seeks to evaluate whether
there are additional benefits from exercise rehabilitation
over specialist heart failure nurse management and to
establish the cost-effectiveness and patient acceptability of
a predominantly home-based programme of exercise
rehabilitation. In addition, the study will investigate the
patient experience of heart failure and rehabilitation
whilst attaining information about effectiveness, uptake
and compliance of patients in a predominantly home-
based setting.
Methods/Design
BRUM-CHF is a randomised controlled trial of exercise
rehabilitation in heart failure comparing specialist heart
failure nurse care alone with specialist heart failure nurse
care plus a structured exercise intervention.
Prior to commencement of the study, ethical approval was
obtained from Sandwell and West Birmingham Local
Research Ethics Committee (Reference number: 03/10/
708).
Randomisation was performed centrally by computer at
the Birmingham Cancer Clinical Trials Unit, University of
Birmingham. When a patient was identified as eligible for
the study, and had given written, informed consent to take
part, the research nurse telephoned the trials unit. The Tri-
als Unit randomly allocated patients, using the method of
minimisation, stratified by (i) NYHA group, (ii) presence
or absence of atrial fibrillation and (iii) hospital site.
In one arm patients continued with "usual" specialist
heart failure nurse care. In the other arm patients contin-
ued with "usual" specialist heart failure nurse care com-
bined with the exercise programme. The trial design is
summarised in Figure 1. Patients who refused randomisa-
tion continued with their normal specialist nurse care.
Population
The two NHS hospital Trusts and one Primary Care Trust
from which patients were recruited are in the West Mid-
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Identification and recruitment of participants to the BRUM-CHF studyFigure 1
Identification and recruitment of participants to the BRUM-CHF study.
Reviewed for suitability
(n=1639)
Excluded (997)
Not inclusive (468)
Co-morbidities (193)
Cardiac related (153)
Miscellaneous (102)
No English (77)
Unable to recruit before
study end (n = 4)
Invitation to participate
(n=642)
Refusals (284)
Exclusion (172):
Ineligible (18)
Co-morbidity (56)
Cardiac related (22)
Miscellaneous (45)
No English (21)
Unable to recruit before
study end (10)
Agreed to assessment
(n=185)
Declined to participate
(n=5)
Informed consent obtained
Collection of baseline data
(n=181)
Contraindicated at ISWT
(n=12)
Randomisation stratified by
NYHA, AF and centre
(n=169)
Normal Heart Failure
Nurse input only
(n=85)
Normal Heart Failure Nurse
input and individualised exercise
programme (n=84)
6-month follow-up
ISWT and questionnaire
12-month follow-up
questionnaire
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lands, UK, covering a combined multiethnic population
of approximately one million with a high incidence of
heart disease. Recruited patients had left ventricular systo-
lic dysfunction with an ejection fraction of 40% or less
measured quantitatively, or classed qualitatively as 'mod-
erate to severe impairment' on an echocardiogram, and
were identified from three specialist heart failure nurse
services. Recruitment took place over 19 months. Inclu-
sion and exclusion criteria are summarised in Table 1.
Details of all patients referred to the specialist heart failure
services were collected and suitability for study participa-
tion identified. Potentially eligible patients were con-
tacted, invited to participate and assessed prior to
randomisation by an incremental shuttle walk test (ISWT)
to determine their suitability for exercise and to exclude
patients with symptomatic ischaemia, cardiac arrhyth-
mias or marked hypotension on exercise[34,35].
Baseline data collected prior to randomisation included
the NYHA class, left ventricular systolic ejection fraction,
demographic details (age, sex, ethnicity), disease history
(admissions for heart failure) and past medical history,
current medication, and outcomes (see below).
Interventions
Specialist heart failure nurse care
"Usual care" is that provided by primary and secondary
care with specialist heart failure nurse input. To ensure
homogeneity of the intervention received, especially in
relation to heart failure nurse input and receipt of optimal
medical treatment, patients were recruited from those
referred to the specialist heart failure clinic. The heart fail-
ure nurses had all undergone training from the British
Heart Foundation.
Exercise intervention
The exercise group received "usual care" as described
above, plus an exercise programme which commenced
with three supervised exercise sessions to provide the
patient with confidence and to plan an individualised
exercise programme. This was followed by a home-based
programme with home visits at 4, 10 and 20 weeks, tele-
phone support at 6, 15 and 24 weeks and a manual.
The home programme was predominantly aerobic train-
ing based largely on progressive walking with self-comple-
tion activity logs. Exercise prescription was based upon
the participant's baseline exercise tolerance as measured
by the incremental shuttle walking test. Performance on
this test correlates well with peak VO2 [34,36] An individ-
ually prescribed walking programme was identified from
this test at a speed that corresponded to 70% of peak per-
formance. During the first two weeks of rehabilitation the
speed of walking was secured by the patient with the help
of the rehabilitation team. Targets were set weekly for the
duration and frequency of walks, which largely depended
on an individual's baseline exercise capacity. The pro-
gramme aimed for the patients to achieve 20 to 30 min-
utes of walking 5 times a week after 10 weeks of
rehabilitation. This was monitored with home training
diaries.
Strength training was low intensity, using the patient's
own body weight for resistance. The focus of the strength
training was both upper and lower limb. The "milk bottle
regime" currently used in the rehabilitation programme in
Leicester are used. Patients complete sets of up to 10 rep-
etitions of 8 key exercise using milk bottles filled with
gradually increasing volumes (thus weights) of water. Tar-
gets are set and level of difficulty assessed. Individual exer-
Table 1: Inclusion and exclusion criteria
Inclusion Criteria
Admitted with decompensated heart failure or had heart failure of severity NYHA II or III within the past 24 months
LVSF (left ventricular systolic function) with ejection fraction of <40% or moderate to severe impairment on 2D ECHO
Stable and compensated heart failure for at least 4 weeks
Exclusion Criteria
NYHA IV
Unable to speak English
MI or revascularisation within the past 4 months
Cardiac rehabilitation within the past 6 months
BP < 100 mmHg systolic, demonstrated postural hypotension, or fall in BP on exercise
Disabling CVA (stroke) within the past 6 months
Severe musculoskeletal problems preventing exercise
Unstable angina
Ventricular or symptomatic arrhythmias
Obstructive aortic valvular disease with a gradient of > 35 mmHg
Hypertrophic obstructive cardiomyopathy
Documented severe chronic obstructive pulmonary disease requiring medication
Case-note reported dementia or current severe psychiatric disorder
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cises are omitted in patients with particular needs or
difficulties.
Specific support for the exercise intervention ceases after
six months but patients are encouraged to continue to
maintain their activity levels.
Outcome measures
Follow-up by postal questionnaire and clinical assess-
ment occurs at 6 months and by postal questionnaire at 1
year.
The primary outcome measure is the Minnesota Living
with Heart Failure Questionnaire (MLwHF) Question-
naire[37]. Secondary outcome measures at 6 months are
(i) composite of death or admission with heart failure or
myocardial infarction, (ii) admission with heart failure,
(iii) mortality (all-cause and vascular), (iv) EuroQol[38],
(v) HADS[39], (vi) blood pressure, (vii) self-reported
physical activity, and (viii) distance walked on the
ISWT[36]. At 12 months the ISWT and blood pressure
measurements are omitted.
Process measures to determine the comparability of inter-
vention received from the specialist heart failure service
included self-reported smoking cessation, salt reduction
and alcohol intake. Uptake and adherence to the exercise
intervention are assessed by (i) attendance at the hospital
training sessions, and (ii) patient completed exercise dia-
ries at 4, 10 and 20 weeks in the intervention group.
The study could not be double blind because of the nature
of the intervention. To reduce the potential for bias in
measuring outcomes in the questionnaires we used vali-
dated measurement tools and aimed for clinical follow-up
to be undertaken by an individual who had not provided
the rehabilitation support and was blinded to treatment
allocation. Determination of secondary end-points (hos-
pitalisation for heart failure and vascular mortality) was
by an independent committee blinded to treatment allo-
cation.
Sample Size
The overall power of the trial was determined on the basis
of the primary outcome – health related quality of life.
To detect a 10 point difference between the 'usual care'
and supervised exercise group on the MLwHFQ (13 points
at 1 year in Belardinelli)[22] at the 5% significance level
with 80% power, 140 evaluable subjects at 1 year were
needed. Allowing for 20% mortality and loss to follow-up
a total of 168 recruits (84 per group) were needed.
Statistical analysis
All data will be analysed by intention to treat. Compari-
sons between the primary outcome measure will be made
at two separate time points: 6 months and 1 year to assess
both short and long-term effects of the exercise interven-
tion.
For outcomes measured on a continuous scale (MLwHF
questionnaire, HADS, Euroqol, blood pressure, self-
reported physical activity, distance walked on ISWT), dif-
ferences between the two groups will be investigated using
a least squares regression framework. Differences in time
related clinical outcomes (hospital readmission rates,
mortality and composite of these) will be analysed using
the Kaplan-Meier survival method and the two groups
compared by the Log-Rank test. Multivariate regression
methods will be used to take into account the baseline
measurements for each patient. When baseline informa-
tion is available this provides a more precise estimate of
the treatment effect than either raw outcomes or change
scores[40]. Results will be expressed as means and 95%
confidence intervals.
Qualitative study
The qualitative part of the study seeks to explore what
patients with heart failure understand about their condi-
tion and what they think the role and potential outcomes
of exercise are. The results of the qualitative study will
complement and contextualise the quantitative findings
e.g. people who do not take part may hold negative views
about exercise or that it is dangerous, particularly in a
home environment.
Interviews will be sought with purposive samples of (i)
patients who declined to take part in the study, shortly
after they have been invited; (ii) patients and their carers
who were randomised to both exercise and control
groups: during the exercise programme and at 6 months
after recruitment.
We will use a maximum variety sample that represents the
broadest range of social characteristics[41]. As the process
of this type of research is iterative and reflexive it enables
refinement of the course of enquiry in response to emerg-
ing findings i.e. new ideas mentioned by interviewed
patients are integrated with current knowledge as the
interviews progress and are included in subsequent inter-
views. This process is continued until interviewing is no
longer generating new concepts and interviewing stops at
this stage (i.e. theoretical saturation)[42]. To reach this
stage it is generally estimated that between 20 and 30
interviews per group are necessary[43].
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Economic analysis
The costs of the alternative programmes will be assessed
from two perspectives: NHS and societal. NHS costs will
be based on resource inputs (time with the exercise reha-
bilitation nurse, travel time, drugs, use of NHS resources
including any differences in hospital admissions linked to
heart failure) costed up to include labour and overhead
costs. National average unit costs will be used with explo-
ration of local differences in sensitivity analysis. A cost-
effectiveness analysis will be undertaken based on the out-
come measures described above, with particular emphasis
on deriving estimates of the incremental cost per QALY.
Utility values will be based on the EQ-5D (or EuroQol)
and life years from the mortality analysis described above.
Modelling will be used to extrapolate from the trial (both
in time and by unit cost) and for sensitivity analyses.
Resource use data will be collected as part of the overall
data collection procedures. Bootstrapping will be used to
explore differences in costs. Cost effectiveness results will
be presented in the form of acceptability curves.
Recruitment
The clinical notes of 1639 patients referred to the special-
ist heart failure nurse services were reviewed. Of these 997
(60.8%) were deemed not eligible, or had an exclusion
criterion identifiable from the records (table 2). 468
(50.4%) had not been of NYHA class II or III or admitted
with decompensated heart failure within the previous 24
months, or had an ejection fraction greater than 40%. A
further 153 (15.3%) had a cardiac exclusion criterion, 204
(20.4%) a co-morbid condition precluding a home exer-
cise programme.
The remaining 642 (39%) of patients were contacted by
letter and invited to participate in the study once their
heart failure was stable, and they were on maximised beta-
blocker therapy. At this stage a further 172 (10.5% of total
sample) were excluded and 284 (17.3%) declined to par-
ticipate (figure 1).
The remaining 186 (12% of all initially reviewed patients)
agreed to participate in the study, 2% of these failed to
attend the assessment or changed their mind at assess-
ment. The remaining 181 patients all gave written and
informed consent and were assessed by incremental shut-
tle walk test for suitability before randomisation. We iden-
tified contraindication to home exercise in 12 of the
assessed patients at the ISWT. Overall, only 10% of all cur-
rently alive patients referred to the three heart failure
nurse services in the two years prior to commencing the
study and during the 19 months of recruitment were actu-
ally randomised.
Discussion
The BRUM-CHF study is novel in its evaluation of a pre-
dominantly home-based, structured exercise programme
for patients with heart failure also receiving specialist
heart failure nurse support. Recruitment to the trial has
highlighted that such an exercise programme will be
appropriate for a minority of patients with heart failure.
The majority of patients seen by the specialist heart failure
service were not eligible for the trial, due to factors that
included insufficient or too severe disease severity or pre-
clusion of safe home exercise. In addition, co-morbidities
accounted for large numbers of patients not being suitable
for exercise. The older age of patients with heart failure
means that there will be a high level of co-morbidity,
which was not an issue in previous trials of highly
selected, atypical patients[8]. Poor recruitment to trials of
patients with heart failure has been previously reported,
with a high proportion declining to participate when con-
tacted[44]. A trial of a nurse-intervention in primary care
in the UK recruited 36% of those invited, compared with
26% of eligible patients in our study. Reasons for non-par-
ticipation given included a perception of being too old,
Table 2: Reasons for non-non-eligibility and exclusions from
BRUM-CHF from case-note assessment in patients on specialist
Heart Failure nurse case-loads
Reason for exclusion/ineligibility n %
Not eligible 468 46.9
Co-morbidity 204 20.4
Physically unable 124
Cognitive dysfunction 38
Airways disease 23
Visual disability 11
Malignancy 8
Cardiac related 153 15.3
Recent stent 1
Severe aortic stenosis/abdominal aortic aneurysm 10
Unstable HF, arrhythmias, NYHA IV 81
Implantable cardiac device 19
Awaiting cardiac procedure: CABG/transplant/MVR 4
Recent cardiac rehabilitation 1
Recent myocardial infarction 1
Recent cardiac transplant 1
HOCM 1
Postural hypotension 1
Still being titrated on beta-blocker therapy 33
Miscellaneous 91 9.1
Risk assessment – unsuitable for home-visits 21
Unable to read or write 3
Not living in area 46
Transport difficulties with attending hospital 8
Not contactable 9
Other 4
Unable to speak English 77 7.7
Unable to recruit before study end 40.4
Total 997 100
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too unwell or too busy[44]. This is an issue which will
need to be considered when planning rehabilitation serv-
ices for patients with heart failure.
The qualitative study is being undertaken in a patient
group which has received specialist heart failure nurse
care. Previous research has highlighted the low under-
standing and knowledge about heart failure in patients
with this condition[41,45-50], but this research was prior
to the introduction of specialist heart failure teams. This
research will provide information about whether the
information needs of patients with heart failure are being
met by the new specialist heart failure nurse services.
Competing interests
The author(s) declare that they have no competing inter-
ests.
Authors' contributions
KJ wrote the initial protocol and designed this study.
RCD, GYHL, MKD, JS, AJS, JWM and SJS participated in
the design of the study. RST wrote the statistical elements
of the original protocol and contributed to the design of
the study. SMG designed and wrote the qualitative ele-
ment of the initial protocol. JTI and KJ wrote the initial
draft of this paper. All authors read and approved the final
manuscript.
Acknowledgements
This study is funded by the Department of Health's Policy Research Pro-
gramme, as part of a joint DH/British Heart Foundation Heart Failure
research initiative. The views and opinions expressed in this paper do not
necessarily reflect those of the Department of Health.
References
1. Cowie M, Wood D, Coats A, Thompson S, Suresh V, Poole-Wilson
P: Survival of patients with a new diagnosis of heart failure: a
population based study. Heart 2000, 83:505-510.
2. Croft J, Giles W, Polla rd R, Keenan N, Caspar M, Anda R: Heart fail-
ure survival among older adults in the United States: a poor
prognosis for an emerging epidemic in the Medicare popula-
tion. Arch Intern Med 1999, 159:505-510.
3. McMurray J, Stewart S: The burden of heart failure. Eur Heart J
2002, 4:D50-D58.
4. Jaarsma T, Halfens R, Abu-Saad H, Dracup K, Stappers J, van Ree J:
Quality of life in older patients with systolic and diastolic
heart failure. Eur J Heart Fail 1999, 1:151-160.
5. Stewart S, Pearson S, Horowitz J: Effects of a Home-Based Inter-
vention Among Patients With Congestive Heart Failure Dis-
charged From Acute Hospital Care. Arch Intern Med 1998,
158:1067-1072.
6. Blue L, Lang E, McMurray JJ, Davie AP, McDonagh TA, Murdoch DR,
Petrie MC, Connolly E, Norrie J, Round CE, Ford I, Morrison CE:
Randomised controlled trial of specialist nurse intervention
in heart failure. BMJ 2001, 323:715-718.
7. British Heart Foundation. Heart failure specialist nurse:
evaluation of a new service April 2002-December 2003 British
Heart Foundation 2004 [http://www.bhf.org.uk/publications/uploaded/
bhf%20hfsn%20evaluation%20final%20report.pd].
8. Lloyd-Williams F, Mair F, Leitner M: Exercise training and heart
failure: a systematic review of current evidence. BJ Gen Pract
2002, 52:47-55.
9. ExTraMATCH collaborative: Exercise training meta-analysis of
trials in patients with chronic heart failure (ExTraMATCH).
BMJ 2004, 328:189-192.
10. Rees K, Taylor RS, Singh S, Coats A, Ebrahim S: Exercise based
rehabilitation for heart failure. In The Cochrane Library Oxford:
Update software; 2003.
11. Smart N, Marwick T: Exercise training for patients with heart
failure: a systematic review of factors that improve mortality
and morbidity. Am J Med 2004, 116:693-706.
12. Austin J, Williams R, Ross L, Moseley L, Hutchison S: Randomised
controlled trial of cardiac rehabilitation in elderly patients
with heart failure. Eur J Heart Fail 2005, 7:411-417.
13. Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J,
Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Wil-
liams MA, Bazzarre T: Exercise standards for testing and train-
ing: A statement for healthcare professions from the
American Heart Association. Circulation 2001, 104:1694-1740.
14. Coats A, Adamopoulos S, Meyer T, Conway J, Sleight P: Effects of
physical training in chronic heart failure. Lancet 1990,
335:63-66.
15. Belardinelli R, Georgiou D, Scocco V, Barstow T, Purcaro A: Low
intensity exercise training in patients with chronic heart fail-
ure. Am J Coll Cardiol 1995, 26:975-982.
16. Hambrecht R, Niebaure J, Fiehn E, Kalbere B, Offner B, Hauer K,
Riede U, Schlierf G, Kubler W, Schuler G: Physical training in
patients with stable chronic heart failure: effects on cardi-
orespiratory fitness and ultra-structural abnormalities of leg
muscles. Am J Coll Cardiol 1995, 25:1239-1249.
17. Hornig B, Maier V, Drexler H: Physical training improves
endothelial function in patients with chronic heart failure.
Circulation 1996, 25:210-214.
18. Sullivan M, Higginbotham M, Cobb F: Exercise training in patients
with severe left ventricular dysfunction: haemodynamic and
metabolic effects. Circulation 1988, 78:506-515.
19. Coats AJ, Adamopoulos S, Radaelli A, McCance A, Meyer TE, Ber-
nardi L, Solda PL, Davey P, Ormerod O, Forfar C, Conway J, Sleight
P: Controlled trial of physical training in chronic heart fail-
ure. Exercise performance, hemodynamics, ventilation, and
autonomic function. Circulation 1992, 85:2119-31.
20. Hagberg J, Ehsani A, Holloszy J: Effects of 12 months of intense
exercise training on stroke volume in patients with coronary
artery disease. Circulation 1983, 67:1194-1199.
21. Belardinelli R, Georgiou D, Ginzton L, Cianci G, Purcaro A: Effects
of moderate exercise training on thallium uptake and con-
tractile response to low-dose dobutamine of dysfunctional
myocardium in patients with ischaemic cardiomyopathy. Cir-
culation 1998, 97:553-561.
22. Belardinelli R, Georgiou D, Cianci G, Purcaro A: Randomised, con-
trolled trial of long-term moderate exercise training in
chronic heart failure. Effects on functional capacity, quality
of life and clinical outcome. Circulation 1999, 99:1173-1182.
23. Larsen AI, Gjesdal K, Hall C, Aukrust P, Aarsland T, Dickstein K:
Effect of exercise training in patients with heart failure. A
pilot study on autonomic balance assessed by heart rate var-
iability. Eur J Cardiovasc Prev Rehabil 2004, 11:162-167.
24. Working Group on Cardiac Rehabilitation & Exercise Physiology and
Working Group on Heart Failure of the European Society of Cardiol-
ogy: Recommendations for exercise training in chronic heart
failure patients. Eur Heart J 2001, 22:125-135.
25. Meyer K: Exercise training in heart failure: recommendations
based on current research. Med Sci Sports Exerc 2001,
33:525-531.
26. Department of Health: National Service Framework. Coronary
Heart Disease 2000.
27. Evenson K, Fleury J: Barriers to Outpatient Cardiac Rehabilita-
tion Participation and Adherence. J Cardiopulm Rehabil 2000,
20:241-246.
28. Evenson K, Rosamond W, Luepker R: Predictors of Outpatient
Cardiac Rehabilitation Utilization: The Minnesota Heart
Survey Registry. J Cardiopulm Rehabil 1998, 18:192-198.
29. NHS Centre for Reviews and Dissemination. Cardiac Reha-
bilitation. Effective Health Care 4[4]. University of York 1998.
30. McGee H, Horgan J: Cardiac rehabilitation programmes: are
women less likely to attend? BMJ 1992, 305:283-284.
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Page 9 of 9
(page number not for citation purposes)
31. Parks D, Allison M, Doughty R, Cunningham L, Ellis C: An audit of
phase II cardiac rehabilitation at Auckland hospital. NZ Med
J 2000, 113:158-161.
32. Oka R, De Marco T, Haskell W, Botvinick E, Dae M, Bolen K, Chat-
terjee K: Impact of a home-based walking and resistance
training programme on quality of life in patients with heart
failure. Am J Cardiol 2000, 85:365-369.
33. Georgiou D, Chesson R, Appadoo S, Belardinelli R, Greene R, Parides
M, Glied S: Cost-effectiveness analysis of long-term moderate
exercise training in chronic heart failure. Am J Cardiol 2001,
87:984-988.
34. Morales F, Martinez A, Mendez M, Agarrado A, Ortega F, Fernandez-
Guerra J, montemayor T, Burgos J: A shuttle walk test for assess-
ment of functional capacity in chronic heart failure. Am Heart
J 1999, 138:291-298.
35. Francis D: Low-cost shuttle walk test for assessing exercise
capacity in chronic heart failure. Int J Cardiol 2000, 76:105-106.
36. Keell S, Chambers J, Francis D, Edwards D, Stables R: Shuttle-walk
test to assess chronic heart failure. Lancet 1998, 352:705.
37. Rector T, Kubo S, Cohn J: Patient self-assessment of their heart
failure 2: Content, reliability and validity of a new measure,
the Minnesota Living with Heart Failure questionnaire. Heart
Fail 1987, Oct/Nov:198-209.
38. EuroQol Group: EuroQol: a new facility for the measurement
of health related quality of life. Health Policy 1990, 16:199-208.
39. Zigmond A, Snaith R: The Hospital Anxiety and Depression
Scale. Acta Psych Scand 1983, 67:361-370.
40. Senn S: Statistical issues in drug development Chichester: Wiley; 1997.
41. Rogers A, Addington-Hall J, McCoy A, Edmonds P, Abery A, Coats A,
Gibbs JSR: A qualitative study of chronic heart failure patients'
understanding of their symptoms and drug therapy. Eur J
Heart Fail 2002, 4:283-287.
42. Glaser B, Strauss A: The discovery of grounded theory: strategies for qual-
itative research Chicago: Aldine; 1967.
43. Morse J: Determining sample size. Qual Health Res 2000, 10:3-5.
44. Lloyd-Williams F, Mair F, Shiels C, Hanratty B, Goldstein P, Beaton S,
Capewell S, Lye M, Mcdonald R, Roberts C, Connelly D: Why are
patients in clinical trials of heart failure not like those we see
in everyday practice? J Clin Epidemiol 2003, 56:1157-1162.
45. Rogers A, Addington-Hall J, Abery A, McCoy A, Bulpitt C, Coats A:
Knowledge and communication difficulties for patients with
chronic heart failure: qualitative study. BMJ 2000, 321:605-607.
46. Bethell H, Turner S, Evans J: Cardiac rehabilitation in the UK
2000- can the National Service Framework milestones be
attained? Br J Cardiol 2004, 11:162-168.
47. Jolly K, Lip GY, Taylor RS, Mant JW, Lane DA, Lee KW, Stevens AJ,
BRUM Steering Committee: Recruitment of ethnic minority
patients to a cardiac rehabilitation trial: The Birmingham
Rehabilitation Uptake Maximisation (BRUM) study
[ISRCTN72884263]. BMC Med Res Methodol 2005, 5:18.
48. Office of the Deputy Prime Minister. Indices of deprivation
2004 [http://www.odpm.gov.uk/stellent/groups/odpm_urbanpolicy/
documents/page/odpm_urbanpol_028470.hcsp].
49. Mason S, Gross C, Krumholz H: Representation of South Asian
people in randomized clinical trials: analysis of trials' data.
BMJ 2003, 326:1244-1245.
50. Carney R, Rich M, Freedland K, Saini J, TeVelde A, Simeone C, Clarke
K: Major depressive disorders predicts cardiac events in
patients with coronary artery disease. Psychosom Med 1988,
50:627-633.
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