|Year : 2021 | Volume
| Issue : 2 | Page : 67-73
Effect of home-based structured functional training on functional capacity and quality of life in patients with heart failure with reduced ejection fraction: A randomized control trial
Ekta N Patil1, Mariya Prakash Jiandani1, Ashish Nabar2
1 Physiotherapy School and Centre, Seth GS Medical College and KEMH, Mumbai, Maharashtra, India
2 Department of Cardiology, Seth GS Medical College and KEMH, Mumbai, Maharashtra, India
|Date of Submission||09-Aug-2021|
|Date of Decision||20-Nov-2021|
|Date of Acceptance||24-Nov-2021|
|Date of Web Publication||15-Feb-2022|
Mrs. Mariya Prakash Jiandani
Physiotherapy School and Centre, Seth GSMC and KEMH, Parel, Mumbai - 400 012, Maharashtra
Source of Support: None, Conflict of Interest: None
BACKGROUND: Heart failure (HF) is associated with increased hospitalization, morbidity, and mortality. Cardiac rehabilitation (CR) is an important approach to improve quality of life (QOL); however, postdischarge enrolment becomes difficult for supervised exercise programs because of related barriers of travel resulting in poor long-term adherence and participation. The objective of this study was to evaluate the effect of home-based structured functional training program on the functional capacity and QOL in patients with HF with reduced ejection fraction.
METHODOLOGY: A prospective blinded randomized clinical trial enrolling 27 patients with HF planned for discharge from hospital. They were randomly allocated using lottery table to either control group (usual care) or interventional group (home-based structured functional training). Both groups received patient education on self-care for HF and Phase I CR as standard of care. Functional capacity using six-minute walk distance (6MWD) and QOL using WHOQOL BREF were evaluated post 6 weeks of intervention.
RESULTS: Functional capacity improved by 25.91 ± 12.04 m in control and 70.79 ± 17.69 m in interventional group, respectively. There was a statistically significant difference (P < 0.05) in 6MWD between the groups following 6 weeks of HBsFT. The pre-post comparison of QOL in both the groups was found to be statistically significant for physical health (P < 0.05) and psychological health domain (P < 0.05).
CONCLUSIONS: Home-based structured functional training program (HBsFT) improves functional capacity and QOL in HF patients with reduced ejection fraction.
Keywords: Functional training, heart failure, home based exercises, quality of life, reduced ejection fraction, six-minute walk distance
|How to cite this article:|
Patil EN, Jiandani MP, Nabar A. Effect of home-based structured functional training on functional capacity and quality of life in patients with heart failure with reduced ejection fraction: A randomized control trial. Physiother - J Indian Assoc Physiother 2021;15:67-73
|How to cite this URL:|
Patil EN, Jiandani MP, Nabar A. Effect of home-based structured functional training on functional capacity and quality of life in patients with heart failure with reduced ejection fraction: A randomized control trial. Physiother - J Indian Assoc Physiother [serial online] 2021 [cited 2022 May 21];15:67-73. Available from: https://www.pjiap.org/text.asp?2021/15/2/67/337719
| Introduction|| |
Heart failure (HF) is the leading cause of hospitalization and is associated with high rates of morbidity, mortality, and health-care expenditures. The annual incidence of HF has been found to be from 0.4% to 2.3% per year, suggesting that 120,000–690,000 Indians could develop symptomatic HF due to coronary heart disease every year. Fatigue, breathlessness, swelling over the feet, and decrease in the ability to carry out their day-to-day activities of living are common symptoms. The aggravated symptoms may cause anxiety, depression, and need for frequent hospitalization, thus affecting the quality of life (QOL) of an individual. Cardiopulmonary rehabilitation programs are found to be effective in increasing the functional capacity and enhancing the QOL in HF patients.
Home-based rehabilitation programs overcome related barriers of travel and participation in CR located at centers increasing the probability of participation. There is a time lag after discharge and before the patient comes to the center to avail cardiac rehab facility as a result of lack of immediate referral or inability to travel. Exercise training forms one of the core components of CR which has shown improvements in functional capacity and QOL. Mostly, exercise training programs include exercise on treadmill or bicycle ergometer. It is not always possible for these equipment to be available at home.
Functional training involves training of larger muscle groups in a closed kinetic chain, so that individuals can perform the activities of daily living (ADL) with minimum discomfort. It allows simulation of ADL and does not need any equipment. There are no studies related to use of functional training in HF, hence the need to evaluate the effect of 6 weeks functional training program in HF with reduced ejection fraction (HFrEF) patients immediate postdischarge.
| Methodology|| |
The study was approved by the institutional ethics committee and is registered under CTRI/2019/09/021314. It was a prospective blinded randomized control trial, which recruited patients with either gender between 30–60 years of age, immediately postdischarge, diagnosed with HFrEF with an ejection fraction <40%. Patients with acute coronary syndrome, unstable angina, myocarditis, uncorrected valvular disease, impaired hearing and vision, and ambulatory disabilities were excluded. So also Patients with Health Questionnaire-9 score >4, breathlessness with NYHA class IV and those not willing to give consent were excluded from the study.
A total of 70 patients, admitted to the cardiac ICU of our institute, between June 2019 and February 2020, were screened. Of these patients, 43 patients with age >60 years, locomotion disability, unstable angina, acute coronary syndrome, impaired hearing, and NYHA grade 4 were excluded from the study. The remaining 27 patients with HF planned for discharge, meeting the selection criteria, and consenting to participate were recruited 2 days before discharge and were randomly allocated to the control group (n = 12) and HBsFT intervention group (n = 15) through a computer-generated random number table with intention to treat. The assessor was blinded to the group allocation [Figure 1].
Both the groups received self-care education model and Phase 1 CR on admission. On recruitment into the study, a baseline evaluation of demographic parameters, functional capacity, and QOL was performed. Functional capacity was assessed using the 6-minute walk test (6 MWT) as per the standard recommendations, i.e., after providing a detailed demonstration in which the participant was asked to walk “as far as possible” in 6 min on a 30-meter walk way. QOL was assessed using WHOQOL BREF Questionnaire. Both the groups received self-care education in the form of audiovisual presentation in their regional language with a self-care manual.
Patients in the HBsFT intervention group received home-based structured functional training of low intensity for 6 weeks, prescribed on the basis of the 80% of predicted 6 MWD, and change in vital parameters of heart rate and blood pressure. The protocol incorporated breathing exercise, closed chain upper and lower extremity exercises, chair sit and rise, 1-leg stance, lunge, wall squats, and walk and relaxation. The program was structured to gradually increase the walk distance, repetitions, and sets of lower extremity exercises during the 6 weeks [Table 1]. Patients were educated to the protocol and RPE as routine practice. Exercise intensity HR limit was calculated on the basis of 40% to 80% of exercise capacity using the Karvonen formula. Progression was achieved initially by the distance and then by speed. The duration of the program was based on the patient's ability and was intensified from minimum 5-10 min to 30 min. 10-point Borg's scale of Rate of Perceived exertion (RPE) was used to monitor intensity, which was increased from low intensity RPE 1-2 to RPE 3-4 based on the patient's response to telephonic conversation.
Those in the control group were provided with a self-care model with general instructions for safe walking [Figure 2]. Home compliance chart was provided to the patients and they were asked to follow-up at the end of 3 weeks as per the standard of care. Monitoring the patient's progress was done on telephonic conversation if patients were not able to follow-up. At the end of 6 weeks, both groups were reassessed for outcomes. In order to reduce bias, the investigator was blinded to the patient protocol and did the pre- and postevaluation of outcomes. A telephone conversation was carried out once a week (every Saturday) with patients from both groups to check the health details and ensure compliance by an independent therapist.
|Figure 2: Items of self- care module of patient education in Heart failure|
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| Results|| |
Calculations and statistical analyses were carried using GraphPad Prism Version 8.4.3 (686). The data for 6 MWD and all domains of QOL were normally distributed. Paired t-test was used for comparison within the two groups, and unpaired T-test was used for comparison between the two groups. QOL was analyzed using Wilcoxon signed-rank test for within the two groups and Mann–Whitney U-test was run for comparison between the two groups. The data were presented as mean + standard deviation (SD). Level of significance was kept at P < 0.05 with 95% of confidence interval.
We had recruited 27 HF patients, out of which 2 patients (one each from the control and interventional group) were lost to follow-up till the end of 6 weeks. Hence, the data of 25 patients (male = 17, female = 8) were analyzed at the end of the study. [Figure 1] demonstrates the flow of participants as defined by the consolidated standard of reporting trials (CONSORT) guidelines. The mean age of the patients in the control group was 51.73 ± 7.51 years and in the experimental group was 49.57 ± 9.04 years, respectively. There were 6 males and 5 females in the control group and 11 males and 3 females in the interventional group. The mean ejection fraction in the control group was 31.36 ± 3.93% and in the interventional group was 31.64 ± 4.81%. Both the groups were comparable at baseline. No significant differences were found with regard to the baseline characteristics between the control and intervention groups.
Our study showed improvement in 6 MWD and in all the domains of QOL, in both groups post 6 weeks of intervention. [Table 2] shows the pre- and postchange in 6 MWD in the control and intervention group, which was found to be statistically significant (P < 0.05) and pre- and postchange in QOL in the control and interventional groups is shown in [Table 3]. The difference was found to be statistically significant for physical health domain (P < 0.05) and psychological health domain (P < 0.05) of QOL.
|Table 2: Intergroup and intragroup comparison of six-minute walk distance (m)|
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|Table 3: Intergroup and intragroup comparison of WHO BREF Quality of Life Scale|
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| Discussion|| |
As per literature search, this appears to be the first study of HBsFT immediately postdischarge in patients with HFrEF evaluating effect of functional training. The patients were followed up from admission to post-discharge six weeks. The study evaluated changes in functional measure as 6 MWD and QOL.
The comparison of pre-post difference of 6 MWD in the control (25.91 ± 12.04) and interventional groups (70.79 ± 17.69) (P < 0.05) after 6 weeks showed that improvement in six minute walk distance (6MWD) was greater in the intervention group as compared to the control group and was clinically significant as per minimally clinical improved difference.,
Various exercise training programs have included treadmill walking, stationary cycling, rowing, ergometer, jogging, swimming, and calisthenics as modes of aerobic exercise., All programs are machine based. In HF, there is systemic influence causing muscle weakness. There is a need to promote active lifestyle.
As any program must be tailored according to the patient's limitations and desired activity level., In our study, we included low-intensity functional training, which was gradually progressing based on patient parameters. Low-intensity program was chosen to avoid any cardiovascular event, which may occur in left ventricular systolic dysfunction. Exercise intensity was monitored using the RPE scale. Strength and endurance being an important part of muscle function, the larger muscle groups were targeted using the closed kinetic chain exercises. Functional training involves the same principle as aerobic exercise and enhances muscle mitochondrial activity. The involvement of large muscle mass of lower extremity simulates functional activity required in day to day to life at the same time having adequate threshold intensity to bring about changes required to improve strength and mitochondrial and capillary density and peripheral adaptations that improve oxidative capacity of an exercising muscles., Exercise also improves endothelial function; hence, chronotropic response to the physical activity is improved.
During the 6 weeks duration as per the follow-up and telephonic conversation, none of the patients reported any adverse events like increased dyspnea or edema or syncope. No hospital readmission or any adverse events were noted during the course of 6 weeks of study in any of the group, indicating that the functional training program was safe. Home-based and center-based CR have shown to reduce hospital admission rates, mortality and morbidity, length of stay, and treatment costs significantly in patients receiving structured exercise programs as compared to those who receive the usual clinical care.,
Although duration of our program was of 6 weeks, it did show significant improvement in functional capacity and QOL in physical health and psychological domain similar to low-intensity exercise-based rehabilitation programs for 8 weeks in the exercise capacity, QOL, symptoms, and functional status of coronary artery disease patients with mild-to-moderate left ventricular dysfunction.,,,, Participation of elderly population is less in center-based CR, as they cannot reach out to the centers; hence, a home-based program would be of benefit.
Self-care plays an important role in maintaining physiological stability and improving QOL in patients with HF. Most readmissions are due to poor self-care, which includes non-adherence to medications, diet, and fatigue to engage in physical activities. In this study, the control group also showed a significant improvement in the functional capacity and enhancement in QOL, which can be attributed to knowledge provided toward the self-care counseling in daily routine and weekly telephonic conversation to check for compliance.
A significant improvement in physical health and psychosocial domain was noted in both the groups in our study. Dyspnea and early fatigue in performing the functional activities such as walking, staircase climbing, and squatting in day-to-day life are noted in HF patients. This affects social participation and ultimately the QOL of the individual. Interventional group showed a significant improvement as compared to the control group in physical and psychosocial domain. This is supported by studies done by Sadeghi et al. and Fu et al. Functional capacity is an important prognostic indicator in patients withe heart failure. Training enhances functional capacity, efficiency to perform an activity, and hence self-sufficiency. This improves the ability of a patient to cope with the daily level of physical activity, in turn improving the psychological status of a patient as there is less dependency. As a whole, it is associated with a positive attitude toward life and improvement in their general sense of well-being. Further, improvement in their QOL could help in reduction of mortality rate, hence reducing the financial burden on the family.
Our findings imply that HBsFT without expensive rehabilitation facilities would be feasible, improving functional capacity similar to the use of exercise training equipment would. Compliance with the exercise program was found to be one of the most important factors in our study, which could be because of telephonic follow-up, which may have improved adherence and motivation and ability to exercise without need to travel to center saving on cost and time. The control group was asked about the compliance of self-care, whereas the interventional group was asked about the compliance of exercise protocol and progression. A home program compliance chart was provided to the interventional group during the start of study. Adherence to exercise may be because of attention provided by study personnel to provide compliance charts, telephonic consultations, self care pamphlets. This may have led to clinically significant improvement in six minute walk distance . There were no adverse events reported, the study promotes the use of individually prescribed home based functional training program in patients with heart failure with reduced ejection fraction.
Strength and limitations
This is the first study to incorporate structured functional training immediately after discharge and the patients were followed up from admission to discharge. It proves the safety and efficacy of home-based programs. Our findings imply that HBsFT without expensive rehabilitation facilities would be feasible and practicable. The compliance was checked on telephonic conversation, which was carried out once a week with both the groups to avoid any psychosocial bias and may have led to adherence to the exercise and self-help protocol. Furthermore, they were asked to carry the compliance chart, during the routine follow-up care. In our study, we practiced HBsFT for 6 weeks along with the self-care education module. Limitation of the study was a small sample size as majority of center was converted to COVID care. With shutting of OPDs due to lockdown, the study also provided an opportunity to patients to continue exercises at home.
HBsFT was found to be effective, convenient, well-tolerated, cost-effective, and safe. This can be accepted as an alternative to the patients who cannot undertake center-based rehabilitation services. Furthermore, these programs can motivate patients to continue their exercises and long-term benefits can be achieved. It improved functional status, symptoms and enhanced the physical health and mental well-being of an individual. Hence, implication of such programs should be done in routine practice, so that a large number of patients get benefited.
| Conclusions|| |
A 6-week home-based structured functional training program along with self-care module immediate postdischarge is safe and improves 6 MWD and QOL in patients with HFrEF.
Professor Amita Mehta, Head, P T School and Centre and Dr Praful Kerkar, Head, Department of Cardiology; Seth G S Medical College and KEMH.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]