Heart Views. 2011 Jul-Sep; 12(3): 99–103.

PMCID: PMC3345147
doi: 10.4103/1995-705X.95064: 10.4103/1995-705X.95064 PMID: 22567195

Effects of Combined Early In-Patient Cardiac

Rehabilitation and Structured Home-based Program
on Function among Patients with Congestive Heart
Failure: A Randomized Controlled Trial
Abraham Samuel Babu, Arun G. Maiya, M. Milton George,
Ramachandran Padmakumar,1 and Vasudeva Guddattu2

Department of Physiotherapy, Manipal College of Allied Health Sciences, Manipal, India

1Department of Cardiology, Kasturba Medical College, Manipal, India
2Department of Statistics, Manipal University, Manipal, India

Address for correspondence: Mr. Abraham Samuel Babu, Department of

Physiotherapy, MCOAHS, Manipal 576104, Karnataka, India. [email protected]

Copyright : © Heart Views

This is an open-access article distributed under the terms of the Creative Commons
Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Aims:
To determine the effects of combined in-patient rehabilitation with a home-based
program on function and quality of life.

Setting and Design:

Tertiary care, university teaching hospital, randomized controlled trial.

Patients and Methods:

Thirty admitted patients with congestive heart failure with New York Heart
Association class II -IV. A five step individualised phase-1 cardiac rehabilitation
program followed by a structured home based rehabilitation for eight weeks was
given to the experimental group while the control group only received physician
directed advice. Six minute walk distance was assessed at discharge and follow-
up, while quality of life (SF36) was assessed at admission, discharge, and follow-
up.

Statistical analysis used:

Independent t-test, paired t-test and repeated measures ANOVA with Bonferroni
post-hoc analysis.

Results:
At admission patients in both the groups were comparable. After the phase-1
cardiac rehabilitation, there was a change in the six minute walk distance between
control and experimental group (310 m vs. 357 m, respectively; P = 0.001).
Following the eight week home-based program, there was a greater increase in six
minute walk distance in the experimental group when compared to the control
group (514 m vs. 429 m; P < 0.001). Quality of life as measured by the SF-36 at
the end of 8-weeks showed a statistically significant difference (P < 0.05) in the
experimental group for both the mental and physical components.

Conclusion:
Early in-patient rehabilitation followed by an eight week home based exercise
program improves function and quality of life in patients with congestive heart
failure.

Keywords: Congestive heart failure, early mobilisation, home based

rehabilitation, quality of life, six minute walk distance

INTRODUCTION
Congestive heart failure is a clinical syndrome, which consists of a triad of
symptoms, namely, heart failure at rest or exercise, objective evidence of cardiac
dysfunction at rest and/or response to treatment towards heart failure.[1]

Home-based programs have been gaining popularity over the last decade with
majority of the studies being done In USA, UK and Canada.[2] A recent
Cochrane review by Taylor et al., found that home based and institution based
rehabilitation programs were equally effective in improving health related quality
of life among patients with myocardial infarction.[3] With regard to heart failure,
a review by Hwang et al., found that home-based programs increase exercise
capacity and endothelial function safely.[4]

Recently, the European Association of Cardiovascular Prevention and

Rehabilitation has recommended that “In-patient rehabilitation should begin as
soon as possible after hospital admission”.[5] Yet, there are no studies on the early
in-patient phase of rehabilitation among patients with congestive heart failure.
Insufficient studies also exist from the Asian sub-continent with regard to both in-
patient and home-based cardiac rehabilitation. In a country where patients need to
pay for their healthcare, cost effective treatments remain a priority in the
management of patients in this part of the world.

In order to meet the rehabilitative need of patients with congestive heart failure in
India, it was felt that it is necessary to ascertain whether results from Western data
on home-based programs can be extrapolated to our population. To achieve this
aim, a hypothesis was generated, taking into consideration a void in literature with
regard to early in-patient rehabilitation. The objective of the study was therefore
to find the effects of combined in-patient rehabilitation with a structured home-
based program on function and quality of life among patients with congestive
heart failure.

PATIENTS AND METHODS

The study was cleared by the Institutional Ethical Committee and written
informed consent obtained. The study was also registered on the Clinical Trial
Registry of India (CTRI/2008/091/000298). A prospective randomized controlled
trial was done on 30 admitted patients with congestive heart failure with NYHA
class II-IV assuming that the null hypothesis was true. Patients were randomly
allocated to either a control or experimental group through concealed allocation
using block randomization. Patients with acute myocardial infarction,
uncontrolled tachyarrhythmias, severe orthopedic and neurological problems and
severe valvular disease were excluded from the study.

The sample size for this study was calculated using the comparison of means to
determine a difference of 100m on the six minute walk test (6MWT) while
keeping the power of the study at 80% at a 95% confidence interval. Considering
a drop-out rate of 20%, a total of 15 subjects in each arm were required.
Patients in the experimental group received a physical therapist supervised in-
patient phase-1 cardiac rehabilitation program [Table 1], which was followed by a
structured eight-week phase-2 home based program [Table 2]. During phase-1,
patients were exercised under supervision and monitoring. Exercises were
prescribed using the modified Borg's rating of perceived exertion (RPE) between
3-4/10 during this phase. The various steps served as a guide for which to
progress the patients and this was individualised for each patient. If a patient was
able to perform a particular step without any discomfort, a faster progression was
made. On the contrary, if a patient was not able to perform at a particular level,
the progression was not made until the patient was comfortable at that level. The
patient's relatives were also encouraged to be a part of the rehabilitation program
and were educated on the importance of exercise. Patients and their relatives were
taught to identify heavy exertion (RPE >7) and chest pain (>5 on the visual
analogue scale) so that exercises could be terminated. These same scales were
also utilised during the home-based program.

The control group received physician directed advice on ambulation during their
stay. At discharge, they were given advice on staying active by the treating
physician.

At discharge, both the groups were administered the six minute walk test (6
MWT) according to the American Thoracic Society guidelines.[6] The
experimental group was provided a detailed home based program which consisted
of upper and lower limb exercises and a walking program guided by RPE. The
phase-1 program familiarised these patients to the exercises to be followed during
the home program. They were also provided an exercise log book which was
required to be filled by the patient daily. They were checked by the therapist at the
end of eight weeks to assess the adherence to the program; adherence was defined
for this study as having performed exercises for >80% of the days. The therapist
in charge of the program progressed the exercises and walking distance weekly
after having a telephonic conversation with the patient. The control group
received only regular advice from the treating physician and no rehabilitation was
given to the patients during the course of the study.

Quality of life (QoL) was assessed at the time of admission, discharge and at
eight-weeks follow up using the medical outcome survey short form-36 (SF-36).
[7] The six minute walk distance (6 MWD) was assessed at discharge and follow-
up. It was not assessed at admission as acute heart failure is a contraindication to
the test.
All patients were managed as per the American Heart Association guidelines for
the management of heart failure and also by the same physician during the entire
study period.[8] All patients were started on anti-platelets, diuretics, ACE
inhibitors, and digoxin. Beta-blockers were prescribed only where indicated.

Statistical analysis
The SPSS 16.0 statistical package was used for the analysis. Descriptive statistics
were used to describe the baseline characteristics and appropriate measures of
central tendency and dispersion were used according to the distribution of the
outcome. Normality was checked using the Shapiro Wilk test. Univariate analysis
was done using independent t-test and paired t-test for between and within the
group differences. The non-parametric equivalent, i.e., Mann Whitney U test and
the Wilcoxon Signed rank test, was used if the data was non-normal (NYHA
grading). Multivariate analysis was done using the repeated measures ANOVA
(RANOVA) to assess for overall effect on QoL. Post-hoc analysis using the
Bonferroni analysis was done for the variables which showed a statistically
significant difference. Statistical significance was considered if P < 0.05 at 80%
power.

RESULTS
Thirty patients were recruited to this study, and the flow is shown in the flow
diagram as per the CONSORT statement [Figure 1].[9] The mean age of persons
in this study was 57.7 ± 10.4 years (range 31 to 85 years) with males more
affected (22/30) [Table 3]. There was no statistically significant difference
between the groups at baseline for the various outcome measures. The mean
ejection fraction was 31 ± 10%. However, both the groups were similar in cardiac
function as seen from the ejection fraction (P < 0.05). At discharge, there was a
statistically significant difference seen between the groups for 6MWD (P < 0.05)
which showed a higher distance walked in the group receiving phase-1 CR. At
discharge, 13 patients in the experimental group were in NYHA class II with two
continuing to be in class IV. Those in class III were able to complete stage 4 of the
in-patient rehabilitation program while those in class IV were able to complete
stages 2 or 3.

Changes in the SF36 scores were compared across admission, discharge and
follow-up using the RANOVA. A statistically significant difference (P < 0.05)
was seen for the physical and mental component on the SF36 [Table 4]. A post-
hoc analysis found a significant change between admission and follow up for the
PCS in the control group while in the experimental group, there was a significant
difference between all the three time points for both the PCS and MCS [Table 4].
The difference in QoL scores from admission to follow up showed a statistical
significance when compared between the groups for the PCS and MCS scores on
the SF36 [Table 5]. Changes in general health, vitality, social functioning, role
emotional, and mental health also showed a statistically significant difference
with rehabilitation.

The 6MWD was seen to improve by 90.39 ± 0.42m in the experimental group
while in the control group it was only 52.65 ± 0.46m [Table 6]. Statistical
significance was also seen on the paired t-test (P < 0.05). No adverse events
occurred during the course of the training program or during the administration of
the 6MWT.

DISCUSSION
This study was a randomized controlled trial on patients with congestive heart
failure to determine the effects of an in-patient rehabilitation followed by a home-
based program on function. The study found significant changes in the six minute
walk distance and the quality of life following the home-based rehabilitation
program. In a developing country like India, where cost of treatment is a major
concern, the use of home based rehabilitation programs would play a great role in
improving function and QoL among patients with congestive heart failure.

A significant difference with regard to functional capacity and QoL has been seen
in this study after eight weeks of training. This is similar to previous study
wherein improvements in functional capacity were found after two months of
training.[10] An 18% change in peak oxygen uptake has been seen in patients
with congestive heart failure after an eight week home based training program.
[11] Belardinelli et al., found that after the initial two months, there was no
further increase in functional capacity with a maintenance program for 24 months.
[10] This highlights the importance of having patients engage in an exercise
program for at least eight weeks in order to achieve improvements in functional
capacity. A study by Omar et al., found that community based approach to
patients with congestive heart failure improved QoL and 6MWD at six months.
[12] These findings were also seen in the home based setting in two months.

Improvement in 6MWD was seen at follow-up following the home based

rehabilitation program. This suggests an improvement in functional capacity in
just eight weeks. A study by Berent et al., found that the physical working
capacity improved in just 25 days with a residential program.[13] However, with
regard to home-based programs, it is still not clear as to how many days are
required for benefits to occur.

The adherence rate observed in this study among those in this study among those
excising was found to be 72.6%. The reason for this rate of adherence could be
due to the weekly telephone conversations and follow-up with the patient. This
was a major difference from what was used in the HF-ACTION study wherein
telephone calls were made once every two weeks to once every three months.[14]
However, better methods to assess adherence would be required and it will be
worth studying the benefits of pedometers in the Indian setting to guide exercises
among patients with congestive heart failure.

Barriers to this home-based program were assessed through a semi-structured

interview on the 14 patients who completed the rehab program. The main barriers
seen were fear (10/14), lack of interest (7/14), lack of motivation (6/14), and
family fears and concerns (9/14). These factors would need to be taken in account
when prescribing a home-based program to patients with congestive heart failure
in India.

This study, to the best of our knowledge, is the first of its kind in India, wherein
an early phase-1 program has been followed by a structured home based program.
From this study, it is clear that an early rehabilitation program begun once the
patient is medically stable is of great importance in improving walking distance
and physical components on the SF-36. These benefits can be sustained if
accompanied by a structured home-based program for eight weeks. Significant
improvements in QoL and 6MWD were seen during this period in both the
groups; however, the changes were more in the experimental than the control
group. This shows that cardiac rehabilitation along with optimal drug therapy is
essential for improving QoL and function among patients with congestive heart
failure.

Long term follow-up after cessation of this eight week program would provide
valuable data regarding the carry-over effect. It would also be interesting to note
the number of persons who did continue to follow the exercises and whether such
programs are beneficial and feasible for patients within India and others South
Asian countries, where the cost of treatment is a major concern for the patient.

CONCLUSION
A combined in-patient, exercise based, cardiac rehabilitation program followed by
a structured home based program, improves function and quality of life among
patients with congestive heart failure.

ACKNOWLEDGEMENT
The authors acknowledge Ms. Prachi Shah and Mr. Saurab Naik for all their help
in this study.

Footnotes
Source of Support: Nil

Conflict of Interest: None declared.

REFERENCES
1. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-
Wilson PA, et al. ESC Guidelines for the diagnosis and treatment of acute and
chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of
Acute and Chronic Heart Failure 2008 of the European Society of Cardiology.
Developed in collaboration with the Heart Failure Association of the ESC (HFA)
and endorsed by the European Society of Intensive Care Medicine (ESICM) Eur
Heart J. 2008;29:2388–442. [PubMed: 18799522]

2. Clark AM, Haykowsky M, Kryworuchko J, MacClure T, Scott J, DesMeules

M, et al. A meta-analysis of randomized control trials of home-based secondary
prevention programs for coronary artery disease. Eur J Cardiovasc Prev Rehabil.
2010;17:261–70. [PubMed: 20560165]

3. Taylor RS, Dalal H, Jolly K, Moxham T, Zawada A. Home-based versus

centre-based cardiac rehabilitation. Cochrane Database Syst Rev.
2010;1:CD007130. [PMCID: PMC4160096] [PubMed: 20091618]

4. Hwang R, Redfern J, Alison J. A narrative review on home-based exercise

training for patients with chronic heart failure. Phy Ther Rev. 2008;13:227–36.

5. Piepoli MF, Corra’ U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, et

al. Secondary prevention through cardiac rehabilitation: From knowledge to
implementation. A position paper from the Cardiac Rehabilitation Section of the
European Association of Cardiovascular Prevention and Rehabilitation. Eur J
Cardiovasc Prev Rehabil. 2010;17:1–17. [PubMed: 19952757]
6. ATS Committee on Proficiency Standards for Clinical Pulmonary Function
Laboratories. ATS Statement: Guidelines for the Six-Minute Walk Test. Am J
Respir Crit Care Med. 2002;166:111–7. [PubMed: 12091180]

7. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-
36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.
[PubMed: 1593914]

8. Jessup M, Abraham WT, Casey DE, Feldman AM, Francis GS, Ganiats TG, et
al. Writing on behalf of the 2005 guideline update for the diagnosis and
management of chronic heart failure in the adult writing committee. 2009 Focused
update: ACCF/AHA guidelines for the diagnosis and management of heart failure
in adults: A report of the American College of Cardiology Foundation/American
Heart Association Task Force on Practice Guidelines. Circulation.
2009;119:1977–2016. [PubMed: 19324967]

9. Schulz KF, Altman DG, Moher D for the CONSORT Group. CONSORT 2010
Statement: Updated guidelines for reporting parallel group randomised trials.
PLoS Med. 2010;7:e1000251. [PMCID: PMC2844794] [PubMed: 20352064]

10. Belardinelli R, Georgiou D, Cianci G, Prcaro A. Randomized, controlled trial

of long term moderate exercise training in chronic heart failure. Effects of
functional capacity, quality of life and clinical outcomes. Circulation.
1999;99:1173–82. [PubMed: 10069785]

11. Coats AJ, Adamopoulos S, Radaelli A, McCance A, Meyer TE, Bernardi L, et

al. Controlled trial of physical training in chronic heart failure: Exercise
performance, hemodynamics, ventilation, and autonomic function. Circulation.
1992;85:2119–131. [PubMed: 1591831]

12. Omar AR, Suppiah N, Chai P, Chan YH, Seow YH, Quek LL, et al. Efficacy
of community-based multidisciplinary disease management of chronic heart
failure. Singapore Med J. 2007;48:528–31. [PubMed: 17538751]

13. Berent R, von Duvillard SP, Crouse SF, Auer J, Green JS, Sinzinger H, et al.
Short term residential cardiac rehabilitation reduces B-type natriuretic peptide.
Eur J Cardiovasc Prev Rehabil. 2009;16:603–8. [PubMed: 19494782]

14. O’Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, et al.
Efficacy and safety of exercise training in patients with chronic heart failure: HF-
ACTION randomized controlled trial. JAMA. 2009;301:1439–1450.
[PMCID: PMC2916661] [PubMed: 19351941]
Figures and Tables
Table 1
Four step phase-1 cardiac rehabilitation protocol
Table 2
Structured home-based program
Figure 1

Open in a separate window

CONSORT flow diagram
Table 3
Demographics of patients at admission
Table 4
Quality of life scores during the study period
Table 5
Differences in QoL scores between the groups from baseline to follow-up
Table 6
Six minute walk distance (in meters) at discharge and follow up

Articles from Heart Views : The Official Journal of the Gulf Heart Association are
provided here courtesy of Wolters Kluwer -- Medknow Publications