Download Werner Benzer, Marion Platter, Neil Oldridge, Helmut Schwann

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Brief resume of the intended work:
6.1 Need for the study :
Cardiovascular disease death accounts for 24 percent of total deaths. As expected CVD
mortality rates to be high in urban than in rural areas, and CVD is much more prevalent among the
upper and middle classes. In 1960, CHD represented four percent of all CVD deaths, whereas in
1990 the proportion was greater than 50 percent CAD death rates are currently about three times
higher than stroke rates (WHO-2002). In the clinical course of CAD, there are many aspects where
patient’s quality of life may be affected.1
Coronary artery bypass graft (CABG) surgery is a common intervention in treating coronary artery
disease (CAD).2 Following CABG there may be many post-operative complications like
haemorrhage, pain, infection of the suture site and other physical problems which could lead to
change in quality of life. Taking care of such magnitude of complications is a challenge for
medical staff to come out with definite outcomes.
World Health Organisation (WHO) defined quality of life (QOL) as individuals' perceptions of
their position in life, in the context of the cultures and values in the societies in which they live and
in relation to their goals, expectations, standards and concerns. Quality of life can also be defined
as the subjective experience of a person’s own life.3,4
The quality of life following CABG has been shown to have significant improvement when the
individual has undergone exercise as a part of cardiac rehabilitation.5
Moderate to vigorous exercise is now prescribed not only for the prevention of ischemic heart
disease but also as a major component of treatment after myocardial infarction, angioplasty,
coronary bypass surgery, heart transplantation, congenital heart disease and stable congestive heart
failure.6-11.
Exercise-based cardiac rehabilitation programs can promote comprehensive cardiovascular
disease risk reduction, decreases in cardiovascular morbidity and mortality, improve in quality of
life and associated economic benefits.12 There has been a rapid and significant growth in the
measurement of quality of life as an indicator of health outcome in patients with coronary artery
disease (CAD).13
Health-related quality of life (HRQL) outcome refers to a multitude of subjective and objective
experiences among which health, well-being and the ability to function in day-to-day activities are
essential14. Numerous generic and disease-specific questionnaires have been developed but there is
no general consensus on their relative merits. 15,16.
HRQL instruments provide a valuable tool to assess the impact of disease, effect of treatment and
other variables affecting people's life. Outcome measures used to evaluate HRQL among cardiac
patients have been introduced.17,18 Assessing patients for quality of life post surgery is very vital
for progression of physiotherapy procedures and for long term rehabilitation.
The MacNew Heart Disease HRQL questionnaire [Mac-New] is a self-administered modification
of the original quality of life in myocardial infarction (QLMI) instrument.19,20 The Mac-New
consists of 27 items which fall into three domains physical, emotional & social function domain
scale. It is reliable & valid in assessing quality of life in heart diseases.21
In Indian population post CABG IInd and IIIrd phase cardiac rehabilitation awareness is
growing and home based cardiac rehabilitation has been proved to be effective in improving
quality of life.22 Many people do follow it, may be its supervised or unsupervised follow up. How
far it is realistic and accurate can be found out by this study through disease specific MacNew
HRQOL questionnaire.
Aim of this particular study is to determine the effect of supervised versus unsupervised home
based cardiac rehabilitation in improving health related quality of life after CABG by MacNew
questionnaire which will be helpful for clinical purpose.
Hypothesis:
Research Hypothesis:
There will be significant improvement in health related quality of life in supervised home based
cardiac rehabilitation groups after 12 weeks of CABG.
6.2 Review of Literature:
Milton George M, Arun G Maiya, Siva Kumar T 2008 conducted a study on 60 subjects at
kasturba medical college hospital Manipal, India. To study the effect of home based cardiac
rehabilitation program on quality of life in low and moderate risk patients with Coronary artery
disease in rural Indian populations. SF-36 questionnaire was administered to assess the quality of
life at baseline and after three months of rehabilitation program .study concluded Home based
cardiac rehabilitation proved to be effective in improving quality of life in coronary artery disease
patients which increased the availability and feasibility than institutional based cardiac
rehabilitation which was out of reach for these patients.22
Werner Benzer, Marion Platter, Neil Oldridge, Helmut Schwann 2007 conducted a study on
216 patients to determine a short-term patient reported outcomes after different exercise-based
cardiac rehabilitation programmers. by this study results suggest that, if patients have to be
admitted for inpatient exercise-based cardiac rehabilitation, this program should be followed by an
outpatient exercise-based cardiac rehabilitation to further improve and stabilize these patientreported outcome variables.5
Smith KM, Arthur HM, McKelvie RS, Kodis J 2004 conducted study to examine the
sustainability of observed changes in physical, quality of life (HRQL), and social support (SS)
outcomes in patients 12 months after discharge from a randomized controlled trial (RCT) of 6
months of monitored home-based versus supervised hospital-based CR. this study suggests that
low-risk patients whose CR is initiated in the home environment may be more likely to sustain
positive physical and psychosocial changes over time than patients whose program is initially
institution-based.23
Otso Ja¨rvinena, Timo Saarinenb, Juhani Julkunenb, Heini Huhtalad, Matti R. Tarkkaa
2003 have done a study on 508 CABG patients were to investigate changes in health-related
quality of life, overall performance status and symptomatic status during 1 year after CABG
surgery and they have concluded that Elderly patients not only have higher mortality and morbidity
but also derive less benefit from CABG regarding certain aspects of QOL24.
.
Anastasios Merkouris et al 2008 conducted a study to explore the quality of life of elderly
patients after coronary artery bypass graft (CABG) surgery. elderly patients (≥65 years), were
interviewed before, 4 months and 12months after CABG with the MacNew Heart disease healthrelated quality of life questionnaire. They concluded that high proportion of the patients
experienced improvement while a substantial number had exacerbations related to self confidence
and dependence to others25.
Doris S F Yu, David R Thompson, C M Yu, Neil B Oldridge 2008: conducted a study to
evaluate the psychometric properties of the Chinese version of the MacNew Heart Disease HRQL
questionnaire (MacNew), the Short-form 36 Health Survey and the Hospital Anxiety and
Depression Scale were administered to 365 Chinese-speaking patients with CHD at baseline and
again 3 months later (n = 363).and they concluded that the MacNew questionnaire may have value
as a core CHD questionnaire for treatment outcome comparisons among pure or mixed populations
of patients with myocardial infarction, angina or heart.26
J-H Krannich, S Lueger, P Weyers, O Elert 2007 conducted a study on 142 patients to assess
the expected benefit of coronary artery bypass graft (CABG) surgery. completed the German
version of the SF-36 health survey questionnaire (SF-36) [ ]. The SF-36 was administered 2 days
before, 10 days and one year after CABG surgery. While HRQL is slightly reduced 10 days after
CABG surgery, the improvement one year later is highly significant compared to two days before
CABG surgery. One year after CABG surgery, the HRQL of our patients is much closer to that of
the standard population of the SF-36.by the study results they concluded According to HRQL,
patients benefit from CABG surgery.27
Stevens R, Hanson P 1984 conducted a study to find a Functional capacity and cardiovascular
responses to serial graded treadmill testing were compared in 180 patients who performed
prescribed unsupervised exercise and 24 patients who were referred for supervised exercise after
coronary artery bypass surgery Improvement in functional capacity was not influenced by
therapeutic beta blockade. These findings indicate that prescribed unsupervised exercise can be
performed safely and results in similar functional improvements compared with supervised
exercise after uncomplicated CABS.28
Stefan Höfer, Lynette Lim, Gordon Guyatt and Neil Oldridge 2004 have done a review
evidence supporting study on the measurement properties of the MacNew Heart Disease Healthrelated Quality of Life [MacNew] Questionnaire. Reliability was demonstrated by using internal
consistency and the intraclass correlation coefficients for the three domains in the Dutch, English,
Farsi, German, and Spanish versions of the MacNew. With internal consistency and intraclass
correlation coefficients =>0.73, reliability is high. Validity of the MacNew was examined with
factor analysis and three core underlying factors, physical, emotional, and social, were identified,
explaining 63.0 – 66.5% of the observed variance and replicated in the translations with
psychometric data. this study concluded that The MacNew may be a valuable tool for assessing
and evaluating health related quality of life in patients with heart disease29.
Daskapan A, Höfer S, Oldridge N, Alkan N, Muderrisoglu H, Tuzun EH 2008. conducted a
study to determine the reliability and validity of the Turkish version of the MacNew Heart Disease
HRQL Questionnaire (MacNew) in patients with angina. The Short Form SF-36, the MacNew, and
the Hospital Anxiety and Depression Scale were completed by the 125 patients in first 2-3 days
after admission to the coronary care unit. Internal consistency reliability and reproducibility
(intraclass correlation coefficients, ICC) of the MacNew were assessed, and test-retest
reproducibility was evaluated over a 2-month period in 25 clinically stable patients by this study
concluded that The MacNew appears to be reliable and valid in Turkish patients with angina.30
Maes S, De Gucht V, Goud R, Hellemans I, Peek N. 2008. Have done study on 6749 cardiac
rehabilitation patients to investigate MacNew and its discriminating capacity between diagnostic
disease categories, sex and age at entry (T1) and at the end (T2) of cardiac rehabilitation as well as
the responsiveness of the MacNew during this period. The MacNew also proves to be an adequate
evaluation instrument for cardiac rehabilitation and It is suggested to complement the use of the
MacNew both at T1 and T2 with a brief anxiety and depression measure, which is valid and
responsive for different groups of cardiac rehabilitation patients.31
K Jolly, R Taylor, et al.2007.conducted a study to evaluate the relative effectiveness and costeffectiveness of a home-based programme of cardiac rehabilitation using the Heart Manual, with
centre-based programmes. It also sought to explore the reasons for non-adherence to cardiac
rehabilitation programmes. by the study concluded home-based cardiac rehabilitation programme
for low- to moderate-risk patients does not produce inferior outcomes compared with the
traditional centre-based programmes. With the level of home visiting in this trial, the home-based
programme was more costly to the health service, but with the difference in costs borne by patients
attending centre-based programmes. Different reasons were given by home and hospital cardiac
rehabilitation patients for not taking up or adhering to cardiac rehabilitation, with home-based
patients often citing a lack of motivation to exercise at home.32
6.3 Objective of the study
● To examine the HRQOL post coronary artery by-pass surgery by MacNew questionnaire.
● To examine the MacNew health related quality of life (HRQOL) in supervised and
Unsupervised exercise groups after three month of discharged subjects.
Materials and Methods:
7.1 Source of Data
Wockhardt hospitals, Cunningham road, Bangalore.
Wockhardt hospitals, Bannerghatta road, Bangalore.
Jayadeva institute of cardiology, Bangalore.
Narayana institute of cardiology, Bangalore.
Apollo hospitals, Bangalore.
Colombia Asia hospitals, Bangalore.
7.2 Method of collection of data:
Population: Patients undergoing CABG.
Sample design: Random sampling
Study design: Randomized Comparative Evaluation study.
Sample size: 60 (30 in each group)
Duration of the Study: 12 weeks.
Materials required: MacNew questionnaire to asses quality of life.
Inclusion criteria:
 Subject who is undergone CABG surgery.
 Both gender with age group of 40-70.
Exclusion criteria:
 Patients unable or unwilling to complete the study.
 CABG associated with other heart surgeries.
 Patients with severe respiratory and neurological problems.
 Who previously undergone CABG.
Methodology:
Subject who have undergone CABG and who fulfill the inclusion criteria will be included in the
study. A written informed consent will be taken from all subjects prior to participation. All the
subjects HRQOL will be assessed two times during the study by using MacNew questionnaire.
During inpatient cardiac rehabilitation standard intervention protocol will be followed.
Baseline reference will be assessed at time of discharge by the MacNew HRQOL questionnaire
and education regarding progression of activity as a home based exercise program and do’s and
don’ts will also be taught to the patient as given below.
All subjects will be given orientation to the cardiac rehabilitation program, two sessions of
informal health education about their condition and disease will be given to these patients and to
their family members and awareness about cardiac rehabilitation and its benefits will be explained
to the subjects. Risk factors modifications for individual patients, life style modification which
include nutrition, weight control advice, relaxation, behavior modification and smoking cessation
advice will also be given prior to the start of rehabilitation program.
Exercise component of cardiac rehabilitation program will be an individualized program of
aerobic exercises preferably brisk walking. Initial session of exercise prescription and training will
be given in the department under supervision and then the home program protocol will be given to
the patient to be performed at home for 12 weeks. Patients will be given training in palpating the
pulse and calculating the heart rate and to perceive the Borg’s Rating of Perceived Exertion (RPE)
for monitoring the intensity. They will be given education regarding signs and
Symptoms to be monitored while doing exercise programs and the do and don’ts and the
termination criteria for the exercise will be explained properly to them. Brisk walking will be the
preferred mode of exercise with intensity 60 to 70% HRmax or RPE of 11 to 14.
The duration of exercise program will be for 30 to 50 minutes/day– warm up session for 10
minutes which includes stretching and gentle active exercise to larger muscle groups like lower
limb and trunk muscles, and aerobic walking program for 20 to 30 minutes, and then finally cool
down session for about 10 minutes which includes stretching exercises and gentle active exercise
or walking with slow pace for at least four sessions per week for total durations of 12 weeks. As
patients become more conditioned to the exercise program, progression of the exercise intensity
will be done as per their needs. As the RPE falls with improving fitness the intensity of exercise
will increase at 5 to 10 percent of the maximum heart rate and by maintaining RPE of 11 to 14
throughout the 12 weeks of duration. For the first four weeks exercise training duration of 15 to 20
minutes, from fifth to eight week duration will be increased to 20 to 30 minutes, and the final ninth
to 12th week duration will be increased to 30 to 50 minutes.
Randomly subjects will be divided into A and B groups.
Group A comprises of subjects who will continue the exercise after discharge under supervision.
Group B subjects who will continue the exercise after discharge without supervision.
Group A Subjects will be regularly contacted to find whether they are adhering to the exercise
program or not. Any advice or change in program if necessary will be given.
Re- assessment will be taken from both the groups after 12 weeks from date of discharge.
Outcomes measures: 

MacNew Heart Disease HRQL questionnaire
Components of MacNew HRQOL questionnaire mainly three domains that is physical,
emotional & social function domain scale.
Statistics:
The statistics analysis will be done by SPSS software package for windows (version14) using the
descriptive statistics to analyze Demographic data and MacNew health related quality of life
questionnaire score will analyze by Within group comparison of QOL scores will analyze by using
non parametric test Wilcox on signed ranked test and between groups differences will analyze by
using Mann Whitney U test.
7.3 Ethical Clearance
As my study includes human subjects, ethical clearance for the study has been obtained from
the institutional ethical committee, Padmashree institute of physiotherapy & concerned hospitals in
Bangalore, as per the ethical guidelines for biomedical research on human subjects, 2000.ICMR,
New Delhi.
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