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JOURNAL APPRAISAL

INPATIENT GROUP JULY 2017

BALISI, SAMIEROSE
BATILLER, REINIER
BAUTISTA, RHIAN
CANTONEROS, ZOSIE
MAYHAY, MARC LESTER
PEREZ JR, RONALD
REYNALDO, DONN
SAN RAMON, KATRINA
TAYAG, FRANCIS
YOGUE, SHAIRA AIKO

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INTRODUCTION

According to American Heart Association/American College of Cardiology guidelines, Heart failure is


defined as a complex clinical syndrome that can result from any structural or functional cardiac
disorder that impairs the ability of the ventricle to fill or eject blood. The guidelines underscore that it
is largely a clinical diagnosis that is based on a careful history and physical examination (Jessup, et al.,
2009; Hunt, 2005; McKee, 1979).

Approximately 5 million individuals have HF and over 550,000 are newly diagnosed as having HF every
year in the United States (Roger, et al., 2012).

The major risk factors/predictors for heart failure includes:

Heart diseases (Coronary disease/MI)

Obesity

Diabetes Mellitus

Exercise-based rehabilitation is defined as a supervised or unsupervised inpatient, outpatient, or


community- or home-based intervention including some form of exercise training that is applied to a
cardiac patient population. The intervention could be exercise training alone or exercise training in
addition to psychosocial and/or educational interventions (i.e. comprehensive cardiac rehabilitation)
(Heran, et al., 2011).

CITATION

Sagar, V. A., Davies, E. J., Briscoe, S., Coats, A. J. S., Dalal, H. M., Lough, F., Rees K., Singh, S., Taylor, R. S.
(2015). Exercise-based rehabilitation for heart failure: systematic review and meta-analysis. Open Heart,
2(1), e000163. Retrieved July 10, 2017 from https://doi.org/10.1136/openhrt-2014-000163

STUDY PURPOSE

The aim of this study to update the Cochrane systematic review of exercise-based cardiac rehabilitation
(CR) for heart failure.

LITERATURE

Individuals who suffered from heart failure experiences marked reductions in their exercise capacity
which in turn has detrimental effects on their ADLs, health-related quality of life and ultimately their
hospital admission rate and mortality (Working Group on Cardiac Rehab & Exercise Physiology, 2011).
Even survival after HF diagnosis has improved, it still has a poor prognosis with 30-40% of patients die
within a year (Go, et al., 2014). In line with this, an estimated total annual cost of HF management
according to UK National Health service is currently around 1 billion or around 2% of the total UK
health budget (approx. 70% of this total is d/t costs of hospitalization) (National Institute for Health Care
[NIH], 2010). Previous meta-analysis reported 32% mortality in HF with preserved ejection fraction vs.
41% mortality in HF with reduced ejection fraction over an average of 47 months follow-up (Somaratne,
et al., 2009).

According to previous 2010 Cochrane review, the American College of Cardiology/American Heart
Association, European Society of Cardiology and National Institute for Health and Care Excellence

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recommends exercise-based rehab (CR) consistently which was proven to be effective and safe adjunct
in the management of HF (NIH, 2010).

This study shows that a multidisciplinary heart failure cardiac rehabilitation program, including an
individualized exercise component, coordinated by a specialist heart failure nurse can substantially
reduce both all-cause and cardiovascular readmission rates, improve functional status at 3 months and
exercise tolerance. (Davidson et al 2010)

Interventions designed to improve both physical and psychological symptoms may provide the best
method for optimizing functioning and enhancing HRQOL in patients with HF. (Gary et al 2010)

Exercise training was associated with modest significant reductions for both all-cause mortality or
hospitalization and cardiovascular mortality or heart failure hospitalization. (OConnor et al 2009)

Home-based exercise training programmes may not be appropriate for community-based heart failure
patients. (Jolly et al 2009)

Attention alone was inadequate to positively impact BNP levels or 6-MWT distances, but did have a
positive impact on quality of life after 24 weeks. Although exercise offers enhanced benefits, individuals
with HF unable to participate in an exercise program may still gain quality of life benefits from
participation in a peer-support group that discusses topics pertinent to HF. (Norman et al 2012)

Tai chi exercise may improve quality of life, mood, and exercise self-efficacy in patients with HF. (Yeh et
al 2011)

DESIGN

The study design by Sagar VA, et. al. (2015) uses a Systematic Review and Meta-analysis in accordance
with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The
systematic review used with the Cochrane Handbook for Systematic Reviews of Interventions
meanwhile the Meta-analysis fixed-effect meta-analysis was used except where statistical heterogeneity
was identified then a random-effect model is used. The study design is appropriate as it aims to prove
the effectiveness of exercised based cardiac rehabilitation for subjects with heart failure and a
Systematic Review and Meta-analysis proves the quantity of improvement in heart failure subjects
undergoing CR. The article is a Socket Level IA because the articles used are all RCTs.

A study by OConnor, CM uses a multicenter, randomized controlled trial of patients in the exercise
training group vs patients in the usual care group. All eligible patients were randomized 1:1 using a
permuted block randomization scheme, stratified by clinical center and heart failure etiology (ischemic
vs non-ischemic)

BIASES

- There are only 6 trials that provided an adequate description of the randomization process. The
rest failed to give adequate details to assess the risk of bias however, with the available details,
the risk of bias was judged as moderate & there was no imbalance in baseline characteristics
reported.
- Most studies appeared to perform intention-to-treat analysis, comparing exercise and control
group according to initial random allocation & the nature of the interventions causes it not

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possible to blind the participants and care-givers, though a number of studies did report blinding
of outcome assessment.
- There is no evidence of selective outcome reporting. Some studies may be prone to
performance bias as they failed to report cointervention details for both exercise and control
groups. Only two studies failed to report losses to follow-up or drop-out rates.

SAMPLE

Multicenter, randomized controlled trial.

Participants: 2331 medically stable outpatients with heart failure and reduced ejection fraction.
Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
were randomized from April 2003 through February 2007 at 82 centers within the United States,
Canada, and France; median follow-up was 30 months.

Sample size was justified with participants from April 2003 to February 2007 selected within US, Canada
and France.

Inclusion Criteria

- Left ventricular ejection fraction of 35% or less


- New York Heart Association (NYHA) class II to IV symptoms despite optimal heart failure therapy
for at least 6 weeks

Exclusion Criteria

- major co morbidities or limitations that could interfere with exercise training


- Recent (within 6 weeks) or planned (within 6 months) major cardiovascular events or
procedures
- performance of regular exercise training or use of devices that limited the ability to achieve
target heart rates

Ethics Procedure & Informed Consent

- The protocol was reviewed and approved by the appropriate institutional review board or ethics
committee for each participating center and by the coordinating center institutional review
board. All patients provided written voluntary informed consent.

OUTCOMES

Patients were evaluated through a self-administered questionnaire using Kansas City Cardiomyopathy
Questionnaire (KCCQ), Psychological General Well Being Index & Minnesota Living with Heart Failure
Questionnaire (MLHFQ) before, after and follow-up treatment.

List measures used:

- Kansas City Cardiomyopathy Questionnaire (KCCQ)


- Minnesota Living With Heart Failure Questionnaire (MLHFQ)
- Psychological General Well Being Index (PGWB-S)

- Outcome areas:

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o KCCQ is a new, self-administered, 23-item questionnaire that quantifies physical
limitations, symptoms, self-efficacy, social interference and quality of life; an overall
summary score can be derived from the physical function, symptom (frequency and
severity), social function and quality of life domains. Scores are transformed to a range
of 0-100, in which higher scores reflect better health status.

o MLHFQ is one of the most widely used health-related quality of life questionnaires for
patients with heart failure (HF). It provides scores for two dimensions, physical and
emotional, and a total score; All items same 0-5 Likert scale; A best cut-off value for
MLHFQ scores to identify those patients with good, moderate or poor QoL has not been
determined; The identification of three levels of MLHFQ should be useful in clinical
decision making.

o PGWB-S is a 22-item health-related Quality of Life (HRQoL) questionnaire which


produces a self-perceived evaluation of psychological well-being expressed by a
summary score; widely used in clinical trials and epidemiological research to provide a
general evaluation of self-perceived psychological health and well-being. the original
PGWBI consists of 22 self-administered items, rated on a 6-point scale, which assess
psychological and general well-being of respondents in six HRQoL domains: anxiety,
depressed mood, positive well-being, self-control, general health and vitality. each
domain is defined by a minimum of 3 or a maximum of 5 items. the score for all domains
can be summarized to provide a summary score, which reaches a maximum of 110
points, representing the best achievable "well-being" 0 - (worst possible level of well-
being) and 110 - (maximum level of well being)

INTERVENTION

For exercise training group, a study personnel supervised the training phase: includes walking, treadmill,
or stationary cycling for 15-30 mins per session at a HR corresponding to 60% heart rate reserve for 3
sessions per week for a total of 36 sessions in 3 months. For home exercise, the target training regimen
was 5 times per week for 40mins at a heart rate of 60-70% of heart rate reserve. For usual care group
which was supervised by a study personnel, they were given a detailed self-management educational
booklet at the time of enrollment which includes information on medications, fluid management,
symptom exacerbation, sodium intake, and activity level of 30 minutes (as tolerated) of moderate
intensity activity on most days of the week consistent with the American College of
Cardiology/American Heart Association guidelines.

All patients were asked to return for clinic visits every 3 months for the first 2 years of participation and
yearly thereafter for up to 4 years. Cardiopulmonary exercise testing and a 6 MWT were performed at a
3, 12 and 24-month follow-up visits. All patients were to be called every 2 weeks for the first 9 months,
monthly until 24 months of follow-up, and quarterly thereafter. During these calls, patients in the
exercise training group were asked questions to determine if they were performing the exercise training
regimen as prescribed. Patients in the usual care group were asked if they were exercising.

In addition, all patients were asked to complete a physical activity questionnaire at the baseline, 6-
month, 12-month, 24-month, 3-year, and final visits.

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Contamination was avoided with the usual care group having a self-management booklet and well-
supervised with series of follow-up visits.

Cointervention was avoided with the exercises performed with supervisions and compliance with the
guidelines on the booklet.

RESULTS

A total of 2331 patients were enrolled at 82 participating centers.

In the primary analysis, exercise training resulted a nonsignificant reduction in the primary end point of
all-cause mortality or hospitalization (HR, 0.93 [95% CI, 0.84-1.02]; P = .13). Prognostic factors were
found and the analysis were adjusted for these covariates (duration of the cardiopulmonary exercise
test, left ventricular ejection fraction, Beck Depression Inventory II score, and history of atrial fibrillation
or fluter)and heart failure etiology, exercise training was found to reduce the incidence of all-cause
mortality or all- cause hospitalization (the primary end point) by 11% (HR, 0.89 [95% CI, 0.81-0.99];
P=.03) .There was no significant difference in the number of deaths (189 patients [16%] in the exercise
training group vs 198 patients [17%] in the usual care group; HR, 0.96 [95% CI, 0.79-1.17]; P = .70)

In the Secondary End Points, Exercise training had a nonsignificant reduction in the combined end point
of cardiovascular mortality or cardiovascular hospitalization in the main analysis (632 patients [55%] in
the exercise training group vs 677 [58%] in the usual care group; HR, 0.92 [95% CI, 0.83- 1.03]; P = .14)
and after adjustment for prognostic factors (HR, 0.91 [95% CI, 0.82-1.01]; P=.09)

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There was a nonsignificant reduction in cardiovascular mortality or heart failure hospitalization (344
patients [30%] in the exercise training group vs 393 [34%] in the usual care group; HR, 0.87 [95% CI,
0.75-1.00]; P = .06), which was statistically significant after adjustment for prognostic factors (HR, 0.85
[95% CI, 0.74-0.99]; P = .03)

For the post hoc end point of cardio- vascular mortality, heart failure hospitalization, heart
transplantation, or left ventricular assist device implantation, the reduction in HR was 13% with exercise
training (353 patients [30%] in the exercise training group vs 403 [34%] in the usual care group; HR, 0.87
[95% CI, 0.75-1.00]; P = .06). A post hoc analysis of NYHA class showed a difference between the 2 study
groups, with 30% of the exercise training cohort improving by 1 class or more vs 25% of the usual care
cohort (ordinal regression P=.03).

CLINICAL IMPORTANCE

Nonsignificant reductions in the exercise training group for mortality was observed. With modest
significant reductions for both all-cause mortality or hospitalization for exercise training. Other adverse
events were similar between groups. This result will further enhance physical therapists prognosis and
effectiveness of an intervention.

DROP-OUTS

Thirty- nine patients (1.7%) were lost to follow-up but had a median follow-up of 14.6 month. Eighty-
three patients (4%) withdrew consent at a median time of 6.8 months following randomization. A total
of 736 patients completed 36 supervised training sessions with the median time to completion (for 36
sessions) of 3.9 months (interquartile range, 3.4-4.8 months).

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CONCLUSIONS AND IMPLICATIONS

Improvements in hospitalization and health-related quality of life with exercise-based CR was shown in
this updated Cochrane review which is consistent across both patients with HF regardless of type of CR
program. Hence, reducing mortality rate in the longer term.

Implication of these results for practice includes developing a specific and effective exercise-based CR
among individuals who suffered HF. Maintaining a good well-being and an enhanced quality of life
increases the chance of survival in patients with CHF

The main limitations of this study are:

Among RCTs included, there were a general lack of reporting of methods which in turn made it difficult
to assess their methodological quality and judge their risk of bias. However, improvement in the quality
of reporting in recent trials were observed. With the result of funnel plot asymmetry for HRQoL
outcomes indicated evidence of small study bias and therefor, possible publication bias.

For future trials, complete details of the interventions and controls in accordance with Consolidated
Standards of Reporting Trials (CONSORT) should be provided with extension for trials assessing non-
pharmacologic treatment. Many of the included trials have relatively small and of short-term follow-up
in which the number of deaths and hospitalizations reported were small. Majority of these trials
reported low number of deaths and hospitalizations.

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Identifying relative cut-off scores with neural networks for interpretation of the minnesota living with
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https://doi.org/10.1109/IEMBS.2009.5334659

Bilbao, A., Escobar, A., Garca-Perez, L., Navarro, G., & Quirs, R. (2016). The Minnesota living with heart
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Sagar, V. A., Davies, E. J., Briscoe, S., Coats, A. J. S., Dalal, H. M., Lough, F., Taylor, R. S. (2015).
Exercise-based rehabilitation for heart failure: systematic review and meta-analysis. Open Heart, 2(1),
e000163. Retrieved July 10, 2017 from https://doi.org/10.1136/openhrt-2014-000163

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