|Year : 2015 | Volume
| Issue : 1 | Page : 39-44
A study to evaluate the effectiveness of an indigenous exercise protocol in patients with heart failure to improve their quality of life: (Exercise in congestive heart failure study [E - CHF study])
Urvashi1, Kamlesh K Sharma1, Vishwa Prakash Gupta2, Sandeep Seth3
1 College of Nursing, All India Institute of Medical Sciences, New Delhi, India
2 Department of CTVS, All India Institute of Medical Sciences, New Delhi, India
3 Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India
|Date of Web Publication||22-May-2015|
Dr. Kamlesh K Sharma
College of Nursing, All India Institute of Medical Sciences, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
Background: Congestive heart failure (CHF) is characterized by an intolerance to activities of daily living, office environment and shortness of breath in any level of extraneous activity depending on their level of heart failure (HF). This significantly contributes to reduced participation and poor quality of life (QoL) among these patients. Methods: The study was conducted from June 2014 to December 2014 in Cardio-Neuro-Centre, OPD, AIIMS, New Delhi on 40 medically stable CHF outpatients (mean age 46.3±11.4 years) in NYHA class -I & II with 3 month follow-up. IEP (Indigenous Exercise Protocol) training, consisting of one supervised session at baseline visit followed by home-based practice and telephonic encouragement and monitoring of the group was given. Outcome measures were QoL, physiological parameters (6 minute walk test - distance, VO2 max and double product) and frequency of hospitalization. Results: The results showed significant difference between QoL (P < 0.02) as measured by KCCQ, mean walking distance on the 6 minute walk test (P < 0.01) and VO2 max (P < 0.01) at entry and after 12 weeks within the experimental group, but compared to the control group, no significant difference was found between the two groups. Two hospitalizations and one death were reported in the control group, whereas none was reported in the experimental group. Conclusion: IEP was effective in achieving adequate exercise tolerance in experimental group. It showed no deleterious effect and is safe to practice at home, but more evidence is needed to consider using IEP when caring for stable heart failure patient.
Keywords: Heart Failure, Indigenous Exercise Protocol (IEP), Quality of life, Physiological Parameters, hospitalization
|How to cite this article:|
Urvashi, Sharma KK, Gupta VP, Seth S. A study to evaluate the effectiveness of an indigenous exercise protocol in patients with heart failure to improve their quality of life: (Exercise in congestive heart failure study [E - CHF study]). J Pract Cardiovasc Sci 2015;1:39-44
|How to cite this URL:|
Urvashi, Sharma KK, Gupta VP, Seth S. A study to evaluate the effectiveness of an indigenous exercise protocol in patients with heart failure to improve their quality of life: (Exercise in congestive heart failure study [E - CHF study]). J Pract Cardiovasc Sci [serial online] 2015 [cited 2020 Sep 24];1:39-44. Available from: http://www.j-pcs.org/text.asp?2015/1/1/39/157565
| Introduction|| |
Incidence and prevalence for heart failure (HF), a major growing cardiovascular syndrome is increasing. The use of evidence-based therapy for HF has increased as a result of several large clinical trials on the use of pharmacological therapy and devices, but despite these advances morbidities and mortality in HF patient continues to remain high. The data regarding exact prevalence and incidence of HF is not available.  Despite the pharmacological treatment, the HF patients complain of breathlessness, fatigue like symptoms of chronic HF adding to poor quality of life (QoL). Other studies suggest , patients with stable HF who participate in a moderate-intensity combined aerobic and resistance exercise program may improve performance of routine physical activities of daily living (ADL) using a home-based exercise approach. Compared with usual care, in selected HF patients, exercise training reduces HF-related hospitalizations and results in clinically important improvements in health-related QoL. Furthermore, home-based walking showed improvement in the performance, exercise. tolerance time and QoL in HF patients.  Very few studies have been conducted in developing countries regarding the use of exercise training program as non-pharmacological methods.
Exercise guidelines for HF patients are available from the American Heart Association, but India being a developing country, patients here cannot afford high-cost machines and instruments for exercises as in western setups. Therefore, there is a huge need for developing a simple exercise protocol for HF patients in India and to assess its efficacy on QoL in such patients. Hence, the current study is aimed at developing and evaluating the effect of indigenous exercise protocol (IEP) on QoL of HF patients. In India, pharmacological, epidemiological aspects of HF have been well researched, but not much work has been done on nonpharmacological methods such as exercise training to improve QoL, which has stimulated research.
| Methods|| |
The aim of this randomized controlled trial was to generate evidence on the effect of an IEP for HF patients. Flynn et al.  showed that the mean QoL in HF patients in usual care was 66.5 (21.0). Anticipating 20 units more in the experimental group as compared to the usual care with a 5% level of significance and 80% power, the estimated sample size was taken as 18/group considering this as a time bound study. We recruited 40 patients (who met the inclusion criteria) and gave written informed consent to participate from HF clinic (May 2014-September 2014), CNC-OPD, All India Institute of Medical Sciences (AIIMS), New Delhi and were randomized into an experiment and a control group [Figure 1]. All participants continued to receive the usual care, that is, pharmacological therapy and general advice regarding HF management. The experiment group received IEP [Figure 2]. The Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi approved the protocol. Inclusion criteria involve stable HF patients while receiving the same drug therapy, between 14 and 65 years of age under New York Heart Association (NYHA) class II, willing to give consent for the study, able to communicate in Hindi/English and able to complete their ADLs.
Exclusion criteria included decompensated or unstable HF patients, under NYHA class III and IV, having undergone or scheduled for any surgery within last or next 3 months, or having any musculoskeletal disease, or deep venous thrombosis/thrombophlebitis. Those patients who had got recent or having recurrent chest infections in last 3 months or had been been hospitalized in last 3 months and recently undergone an exercise training program were excluded.
Indigenous exercise protocol
The IEP was developed for the purpose of home exercise protocol which can be practiced by the patient and involves-warm up period, breathing exercises, range of motion (ROM), walking (aerobic training) and cool down period [Figure 2].
The warm up exercise included the simple movements of hands and foot for 5 min (10−12 times), breathing exercise included deep inhalation, followed by slow pursed lip exhalation for 5 min (10−12 times), ROM exercise comprises of simple movements of hands and legs for 5 min each at least 5−6 times, slow walk for 5 min, followed by brisk walk for 7 min and normal walk for next 3 min, the last is cool down period comprising of shavasana for 5 min [Figure 2].
In this study, the outcome measures were QoL, physiological parameters (6-min walk test [6MWT] distance, maximal oxygen consumption [VO 2 max] and double product [DP]), and recurrent hospitalization. Patients in both experiment and control group were assessed at the baseline visit, and at 3 months follow-up using the same outcome measures and procedures. QoL refers to patients' perception of impact of illness on their wellbeing as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire with scores ranging on the scale of 0−100 (where extremely limited is 0, quite a bit limited is 25, moderately limited is 50, slightly limited is 75, not at all limited is 100). Hospitalization refers to repeated hospital admissions of HF patients due to cardiac events (after getting enrolled in IEP). Physiological parameters: Involves 6MWT, VO 2 max and DP (or pressure rate product), of the enrolled HF patients. 6MWT was performed using the standardized protocol.  VO 2 max is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill.  Cahalin et al.  formula for calculating VO 2 max through 6MWT was adopted in the present study (peak VO 2 max = 0.03 × distance (m) +3.98). DP or rate-pressure product is used to determine the myocardial workload and allows calculating the internal workload or hemodynamic response. It is calculated as the product of heart rate and systolic blood pressure.  The demographic and clinical profile information of subjects was collected using the pretested self-developed structured questionnaire. The QoL data were collected using KCCQ. A pretested structured sheet was used to gather information regarding hospitalization of patients during the study period. The IEP was learned and practiced by the researcher and competency certificate was provided by the Chief Physiotherapist. The IEP was taught to subjects under the guidance and supervision of cardiologists and physiotherapists [Figure 3].
Data were analyzed using STATA software version 11.2 (StataCorp, 4905 Lakeway Drive, College Station, Texas 77845 USA). As there was drop out of 10 subjects during the study, intention to treat analysis was done (all the subjects recruited during the study duration were analyzed in order to reduce the bias associated with the drop out of subjects). Descriptive statistics (mean, median, standard deviation, range, percentage, and frequency) were used to describe demographic and clinical characteristics. Inferential statistics including Student's t-test, paired t-test, Chi-square, and Wilcoxon rank-sum (Mann − Whitney) used to compare mean scores. The level of significance was taken as 0.05.
| Results|| |
A total of 40 subjects (20 in each group) were recruited, of whom 30 (15 in each group) completed the study. Five subjects in experiment group lost to follow-up (3 declined to come for follow-up and 2 did not come due to transport expenses. In the control group one subject was hospitalized due to cardiac arrest, and another died at home (reason not known) and three declined to come on follow-up (total of 5 lost participants in the control group). The mean age of the total sample (n = 40) was 46.3 ± 11.4 (20−65 years) as shown in [Table 1]. The majority of the subjects were from NYHA class II. The majority had an ejection fraction below 25%. The gender wise distribution and clinical profile of the subjects are shown in [Table 2] and [Table 3], respectively. Both the study groups were found to be comparable in terms of KCCQ quality of life and physiological parameters [Table 4]. At 3 month follow up post test was done on total of 30 subjects (15 per group).The experimental group demonstrated the significant increase in the KCCQ QoL scores, overall summary scores, clinical summary score and physiological parameters (6MWT distance, VO 2 max) from pretest to posttest as shown in [Table 5]. In the control group, the overall summary score significantly improved (P = 0.03). No significant changes were found between the posttest KCCQ scores and physiological parameters of the two groups as shown in [Table 6]. It was found there was no hospitalization during the study period related to cardiac events in the experimental group after getting enrolled in the IEP. For the intention to treat analysis also between the two groups, no significant difference was found between the two groups for KCCQ QoL and physiological parameters. The intention to treat analysis within the groups for QoL, 6MWT distance, and VO2 max is shown in [Figure 4] and [Figure 5].
|Figure 4: Intention to treat - comparison of quality of life, 6-min walk test distance and maximal oxygen consumption within experiment group.|
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|Figure 5: Intention to treat - comparison of quality of life, 6-min walk test distance and maximal oxygen consumption within control group.|
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|Table 4: Comparison of pretest scores of QoL (KCCQ) and physiological parameters (n=40)|
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|Table 5: Comparison of pre- and post-test scores of QoL (KCCQ) and physiological parameters within the groups (n=30)|
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|Table 6: Comparison of posttest scores of QoL (KCCQ) and physiological parameters between the groups (n=30)|
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| Discussion|| |
This study evaluated the effect of IEP on QoL, physiological parameters and recurrent hospitalization in HF patients. The results demonstrated the significant increase within the experimental group in QoL and physiological parameters (6MWT distance and VO 2 max) but no difference was found compared to the control group. No hazardous event was reported in the experimental group as compared to the control group, therefore, it is concluded that IEP is safe to practice.
Similarly, other similar studies , support present study. QoL improved in the trained patients concerning physical, psychological, social and environmental domains, whereas no significant change was found in the untrained patients. Home walking program improved walking distance on the 6-min and QoL scores at entry and after 8 weeks in the training group, but no significant difference was seen between the study groups. Another study  reported that exercise training group achieved a clinically significant change on the KCCQ at 12 weeks, with further improvement by 24 weeks, while the attention-control group demonstrated a clinically significant change at 24 weeks. In contrast to present study result, at 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score compared with usual care alone as reported by Flynn et al. 
For the physiological parameters, the significant change was seen within the experimental group for 6MWT distance and VO 2 max whereas between the study groups no significant difference was found. These findings are supported by other studies , that showed a significant increase in 6-min walk distance at 3 and 12 months in the exercise group but no between-group differences. After exercise training, 6-min walk distance did not improve compared to that of the control group with usual care at 8 weeks or at 24 weeks. On the contrary Lima  found at 12 weeks (36 sessions) of exercise training, the exercise training group had signiﬁcant increase in functional parameters (ΔVO 2 , Δexercise time, Δ6MWT distance) and HQoL compared to inactive control group.
In the present study no hospitalization or death was reported in the experimental group, but two hospitalizations (due to cardiac arrest and dyspnea) control was reported in control group at around 10 weeks after enrolment in the study. These findings are dissimilar to other study results, that is, the HF-related hospitalizations were lower with exercise therapy and compared with usual care, in selected HF patients, exercise training reduces HF-related hospitalizations.  The group had fewer admissions and spent fewer days in the hospital after 8 weeks of cardiac rehabilitation program.  Exercise training significantly reduces mortality and also the secondary end point of death or admission to hospital.  These findings from other studies are contradictory to present study findings.
The Strengths of the present study are that it is a randomized controlled trial, assessing the effect of IEP that needs no instrument or additional cost, and which is developed for the first time for the management of HF patients in India. Furthermore, despite limited control on adherence on exercise protocol there was a significant change in the component of 6MWT distance in the experiment group. Limitations of the study identified were, the study was conducted in a single setting with limited sample size and 25% dropout, and among only systolic HF patients (therefore IEP applicability to the diastolic HF patients is not known). There was no blinding and the complete data collection procedure, assessment, and IEP training was given by the same person. The reliability of adherence to IEP is questionable although it was reported by the subjects to be followed as per instructions. Implications of this study are: (1) IEP can be incorporated in the curriculum of preservice and in service education of the nurses working in Cardiology Department focusing on its indications and contraindications. (2) IEP can be used as an adjuvant therapy for the HF patients to improve their QoL. The nursing personnel caring for a HF patient should be made aware of the indications and contraindications to IEP. (3) Administrative support in terms of infrastructure should be made available in hospital settings for implementing IEP as a nonpharmacological management strategy for treatment of stable HF patients. (4) Further research may be conducted on the use of IEP with a large sample size, in a multi-centered setting, or as supervised sessions in between the follow-up or with different cardiac patients groups, e.g. myocardial infarction, coronary artery disease, etc., The long-term effect of IEP can be assessed in the longitudinal study, or a similar study can be replicated with individual-based exercise intensity.
| Conclusion|| |
It is concluded that IEP is safe to practice at home and has no deleterious effect on the patients. Although no significant difference was found between the study groups, but there was a significant change in the 6MWT distance in the experiment group. More evidence may be needed to consider recommending IEP as the "standard of care" when providing care for stable HF patient.
Authors thanks the KCCQ author - Dr. John Spertus, for providing permission to use KCCQ tool for the purpose of the study.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]