Effect of an exercise programme for elderly patients with heart failure

Transcription

1 Ž. European Journal of Heart Failure Effect of an exercise programme for elderly patients with heart failure Abstract A. Owen a,, L. Croucher b a Department of Cardiology, Kent & Canterbury Hospital, Ethelbert Road, Canterbury, Kent CT1 3LP, UK b Department of Physiotherapy, Kent & Canterbury Hospital, Ethelbert Road, Canterbury, Kent CT1 3LP, UK Received 3 May 1999; received in revised form 12 October 1999; accepted 3 November 1999 Aims: Benefit from exercise training programmes for patients with chronic heart failure has been demonstrated in relatively young Ž mean age 60 years. and predominantly male subjects. This study was undertaken to assess the effect of an exercise programme for older subjects more representative of the general heart failure population. Methods and Results: Twenty-two patients with chronic heart failure of mean age 81 4 years were recruited into the study. Twenty-five percent were female and 31% were in chronic atrial fibrillation. A crossover study design was employed. The programme consisted of once weekly exercise sessions tailored to the abilities of elderly subjects and lasted for 12 weeks. Fifteen subjects completed the exercise component and nine the control component. The programme resulted in a 20% relative increase in 6-min walk test distance Ž ANCOVA: P There was no improvement in quality of life as measured by the Living With Heart Failure Questionnaire, but the majority of subjects reported subjective improvement in wellbeing. Conclusion: Elderly patients with chronic heart failure can benefit from an appropriately designed exercise programme and should not be excluded from future large scale trials European Society of Cardiology. All rights reserved. Keywords: Heart failure; Exercise; Elderly; Quality of life 1. Introduction Exercise training programmes for patients with chronic heart failure, once thought to be contraindicated, have been shown in many small short term trials to improve exercise tolerance, quality of life and haemodynamic indices. An overview of some of these studies has been undertaken 1. The subjects were predominantly male Ž 94%. and relatively young Žmean age years. with only 14 out of 134 subjects older than 70 years and none over 77 years. Subjects not in sinus rhythm or with peripheral oedema were excluded. The duration of the programmes ranged Corresponding author. Tel.: ext. 3031; fax: from 6 to 16 weeks with a 4% mortality over this period. Exercise programmes generally for such patients have usually been quite vigorous and physically demanding involving various combinations of cycle ergometry, cycling, jogging, running and climbing 2. These studies have therefore examined the effect of exercise on a highly selected group of patients. A recent trial was less selective and included patients in atrial fibrillation Ž 14%., 30% women and a slightly older mean age Ž 64 5 years., no patient over 75 years was, however, included 3. The prevalence of chronic heart failure increases rapidly with increasing age 4 and may affect as many as 10% of subjects over 80 years. The purpose of the present study was to examine the feasibility of recruiting elderly subjects with chronic heart failure to an $ European Society of Cardiology. All rights reserved. Ž. PII: S

2 66 ( ) A. Owen, L. Croucher European Journal of Heart Failure exercise training programme. Clearly such a programme would need to be tailored to the abilities of elderly subjects, be substantially less vigorous and be less selective. 2. Methods 2.1. Subjects Patients were recruited from outpatient clinics at Kent & Canterbury Hospital at the time of routine review. In addition, patients who had been discharged were contacted by letter with details of the study and asked if they would like to participate. Inclusion criteria were: Ž. 1 age 75 years; Ž. 2 ejection fraction 40% by echocardiogram; Ž. 3 history of heart failure; Ž. 4 stable condition. The exclusion criteria were: Ž. 1 an indication for physiotherapy, as additional physiotherapy could confound the results; Ž. 2 musculoskeletal limitation of exercise capacity; Ž. 3 inability to attend exercise sessions; Ž. 4 pulmonary disease limiting exercise capacity; Ž. 5 hospital admission within the previous 3 months; and Ž. 6 patients with current good exercise capacity, as such patients would be unlikely to benefit from the relatively low level of exercise provided by the exercise sessions. The study was approved by the local Research Ethics Committee Study design The study was undertaken during 1998 with recruitment of subjects weekly from January to June inclusive at a maximum of three per week. Subjects were assessed clinically by a single cardiologist Ž A.O.. and a physiotherapist Ž L.C.. for eligibility and the collection of baseline data on the Monday. Eligible subjects then proceeded to a practice 6-min walk test Ž 6 MWT.. Subjects were then randomised to control or exercise groups. Previous studies have had difficulty recruiting females and we anticipated this may well be the same for our study so the randomisation process was stratified for gender. It was felt that the numbers likely to be recruited would be too small to allow for stratification of other variables. Following randomisation to control or exercise groups subjects underwent an echocardiogram on the following Thursday by A.O. who was blinded to the subjects group. The following Monday all subjects returned for the study 6MWT. All subjects completed the Living With Heart Failure Questionnaire Ž LWHQ. 5,6 to assess quality of life. This questionnaire has 21 questions relating to various aspects of life. The maximum score is 105 indicating a high degree of limitation and a minimum score of 0 indicating no limitation. Some of the questions are not particularly relevant to elderly subjects but were included to allow comparisons with other studies. Subjects randomised to exercise attended a weekly session at the hospital every Thursday afternoon lasting approximately 60 min. After 12 weeks subjects were reassessed during week 13 with a repeat 6MWT, echocardiogram, LWHQ and a clinical assessment. Subjects then crossed over to the alternative group. Thus, subjects initially randomised to control transferred to the exercise group and subjects initially randomised to exercise transferred to a post-exercise control group. In previous studies using a crossover design such as this 7 subjects in the second control phase were requested to reduce their activity level Ž detrain. and the two control phases were amalgamated. In the present study we wished to examine the effect of discontinued attendance at the exercise sessions without giving any specific instructions to patients to reduce exercise. It was also felt to be unethical to ask elderly subjects to reduce their physical activities. The two control groups were therefore analysed separately as control and post-exercise control in addition to an amalgamated control group. All subjects were reassessed during week 26. In addition to these assessments subjects were assessed clinically at weeks 6 and 20 for safety reasons. Hospital transport was offered to all subjects to attend the assessments and the exercise sessions. In this way it was hoped to optimise attendance Exercise training protocol Patients attended a weekly session within the physiotherapy department for 12 weeks. Resuscitation equipment was available. Each session consisted of three components: Ž. 1 a warm-up phase of joint mobilisation and pulse raising exercises together with muscular stretches undertaken whilst seated. This phase lasted approximately 10 min; Ž. 2 an activity phase of a six station circuit with stations alternating between stamina and strengthening type exercises with 45 s spent at each station. Each subject worked at a rate which was comfortable for them. For subjects who were unable to participate in the circuit a seated set of equivalent exercises alternating between stamina and strength was provided; and Ž. 3 a cool down phase lasting approximately 10 min of seated exercises allowing the heart rate to fall in a controlled manner. The components were similar to the warm up phase but with an emphasis on muscular stretches and joint mobilisation. Subjects were shown how to measure their pulse rate and advised not to exceed a value of 70% of their age predicted maximum as has been recommended 8. The groups consisted of a maximum of eight subjects and two members of staff

3 ( ) A. Owen, L. Croucher European Journal of Heart Failure including a physiotherapist. No special equipment was required. Subjects were not given any specific instructions with regard to exercise at home but were encouraged to do what they felt able to do Statistical analysis Ž. Analysis of covariance ANCOVA was used to assess changes between groups. The paired t-test was used to assess differences in parametric variables and the Wilcoxon log rank test was used to assess differences in non-parametric variables. The distribution of discrete variables between groups was assessed with the Chi squared test. 3. Results 3.1. Baseline ariables The characteristics of the subjects randomised to control or exercise are shown in Table 1. The crossover nature of the study design means that many subjects are represented in more than one group. The data relate to each subject at the time of entry into each group. One quarter of all subjects were female. The randomisation process has ensured that these are equally distributed between the groups. Generally Table 1 Baseline data for the three groups there is a good balance between the groups. The control group has a slightly higher Ž non-significant. proportion of subjects with a history of hypertension contributing to this group having a greater systolic blood pressure Ž non-significant.. Three of four subjects with fixed rate VVI pacemakers were initially randomised to exercise as were all subjects with peripheral oedema. Over half of all subjects had ischaemic heart disease Ždefined as a previous history of myocardial infarction or angiographically proven disease.. It is likely that many others were also affected but did not have the required level of evidence to be so defined. The characteristics of the postexercise group are also given, but by definition all these subjects completed the exercise programme so may not necessarily be similar in all respects to the other two groups. The use of cardiovascular medication was similar between the groups. Seventy seven percent of all randomised subjects were using ACE inhibitor and 27% beta blockers Compliance Control group: Twelve subjects were randomised to this group. Two subjects withdrew for personal reasons after 1 and 11 weeks. One subject died suddenly Ž. Ž. Ž. Control n 12 Exercise n 19 Post-exercise n 9 Age Ž years Age range Ž years Proportion female Ž % Past medical history Ž %. Ischaemic heart disease Atrial fibrillation Hypertension Diabetes Poor vision Stroke VVI pacemaker NYHA Class mean Ž median NYHA Class I II III IV Ž % Ejection fraction Ž % Heart rate Ž beats min Blood pressure Ž mmhg Proportion with oedema Ž % Proportion with raised venous pressure Ž % Medication Ž %. Diuretic ACE inhibitor Beta blocker Digoxin Amiodarone Nitrates Aspirin Warfarin

4 68 ( ) A. Owen, L. Croucher European Journal of Heart Failure days after randomisation. Exercise group: Nineteen subjects were randomised to exercise, nine of whom had crossed over from the control group. One subject withdrew before attending any sessions. This subject was NYHA Class IV and very limited. One subject withdrew after four sessions because of recurrence of a chronic back problem. Two patients died of worsening heart failure, one of whom was unable to attend six out of eight sessions prior to death. Eleven subjects completed all 12 sessions. Compliance was defined as the proportion of sessions attended of the total possible Žto the end of the study, until withdrawal or death.. The median and mean compliance were 100 and 91%, respectively. Fifteen subjects completed this phase of the study. Post-exercise group: Nine subjects entered this group. There were no withdrawals or deaths in this group Safety No adverse reactions attributable to the exercise sessions were identified. One subject in the control group was admitted to hospital with worsening heart failure and was re-admitted while in the exercise group and subsequently died. One subject in the post-exercise group was admitted to hospital with worsening heart failure Mortality The mortality over the 26 weeks of the study was 23%, which includes the deaths of two subjects who withdrew from the study but died within 26 weeks of randomisation Ž one control and one exercise.. The annual mortality for all 22 randomised subjects was 36% Exercise capacity Exercise capacity was assessed using the 6MWT Ž Table 2.. The differences between the 6MWT distance for the control and exercise groups at base line were not significant Ž P Exercise capacity of control subjects tended to decline and that of the exercise subjects tended to increase, the difference being significant Ž ANCOVA: P This represents an approximate 20% relative increase in exercise capacity. The exercise capacity of the subjects in the post-exercise group tended to decline but the difference did not reach the P 0.05 level of statistical significance when compared with the increase achieved by the exercise group. The exercise capacity of the amalgamated control group tended to decline relative to that of the exercise group ŽANCOVA: P Quality of life assessments The median LWHQ scores before and after the intervention for the control group were 28 and 28, respectively and for the exercise group were 22.5 and 23, respectively, i.e. no change. These values are less than might be expected because many subjects declined to answer the questions relating to cost of medication, work and sexual activity. Others answered these questions with zero as they did not feel the questions applied to them. Questions that were not answered before and after intervention were not used in the analysis. All subjects who completed the entire programme Ž 26 weeks. were asked if they felt they benefitted from attending the exercise sessions. Thirteen out of 15 said they had and were very enthusiastic about the sessions. Six subjects spontaneously asked to continue after the end of the study. Nine subjects volunteered that the sessions had given them confidence to undertake greater levels of physical activity during their daily lives such as walking to the local shops. Two subjects felt they had not benefitted, one of these with a baseline 6MWT distance of 379 m was clearly too good for the level of exercise provided by the sessions. The other subject had a poor exercise capacity which improved during attendance at the exercise sessions Ejection fraction The mean ejection fraction for the exercise group before and after the 12-week programme for the 15 subjects who completed this phase was, respectively 26 8% and 25 6%. These values are not significantly different. Table 2 Baseline 6MWT distances for the four groups with the corresponding distance after 12 weeks Baseline Ž m. After 12 weeks Ž m. Change Ž m. P value Control Ž n P Amalgamated control Ž n P 0.02 Post-exercise group Ž n P 0.05 Exercise Ž n a For comparison with exercise group using ANCOVA. a

5 ( ) A. Owen, L. Croucher European Journal of Heart Failure NYHA class The mean NYHA class before and after the 12-week exercise programme for the 15 subjects who completed this phase was and which are not significantly different. 4. Discussion Previous studies of the effect of exercise programmes for patients with chronic heart failure have been highly selective 1. The subjects have been relatively young with a mean age of 61 years, whereas the mean age of patients in the community with chronic heart failure may be as great as 81 years 9. Patients in atrial fibrillation have been largely excluded whereas possibly 50% of patients with chronic heart failure in the community may have atrial fibrillation 9. Female patients have been poorly represented with few studies being able to recruit more than 10% women. The present study was therefore undertaken to determine if the beneficial effects of exercise programmes previously demonstrated for highly selected patients can also be obtained for patients more representative of the general heart failure population. We have been able to recruit patients with a mean age of 81 years some two decades older than that of previous studies, with 25% women and 33% in atrial fibrillation. Subjects were not highly selected and there were only limited exclusion criteria. The subjects had good exposure to both ACE inhibitors and beta blockers. The high mortality of 23% over a 26-week period demonstrates the poor prognosis of heart failure in elderly subjects. The base line 6MWT distance of approximately 200 m is substantially less than the 500 m of younger subjects Ž aged 62. with heart failure of similar severity 10 indicating the greater limitation that elderly subjects have. The programme devised for these elderly subjects involved a combination of aerobic and muscle strengthening exercises and was substantially less vigorous than programmes designed for younger subjects. The sessions were held once weekly with no specific instructions to exercise at home. Previous studies in younger subjects have involved more frequent hospital sessions and or home sessions. Initially we had planned a twice weekly programme of sessions but found it impossible to recruit subjects who would Ž or could. make such a commitment. Many of these individuals, despite their limitations, are carers for spouses or are unable to leave their homes frequently because of prearranged visits from social services agencies. A high level of attendance at the exercise sessions was achieved by providing transport, as many of the participants had no transport of their own. The weekly programme of exercise sessions resulted in a significant Ž P improvement in exercise capacity amounting to approximately 20%. Subjects in the control group suffered a mean decrease in their 6MWT distance of 18 m Ži.e. approximately 1.5 m week. consistent with the natural history of heart failure. The exercise programme not only arrested this decline but achieved an increase in 6MWT distance. Subjects reported that attendance at the exercise sessions gave them confidence to undertake greater activities in their own home environment thus, although no formal instructions were given to exercise at home, many subjects effectively did which may well have contributed to the improvements achieved. The exercise programme did not result in an improvement in ejection fraction which has been a feature of previous studies 2. It would seem likely that the benefits achieved are due to improvements in musculoskeletal function although clearly more accurate measures of cardiac function than ejection fraction may have been improved. Subjects in the post-exercise control group showed a decline in exercise capacity during the 12 weeks after the completion of the exercise programme. These subjects were not asked to decrease their activities during this period. This finding, although not reaching the P 0.05 level of probability, suggests that should exercise programmes become incorporated into standard clinical care they may need to be continued chronically. Quality of life as assessed by the LWHQ 5,6 was not improved by the exercise programme. The vast majority of subjects, however, reported that they did feel better and had benefitted from the programme. This is in keeping with the objectively measured increase in exercise capacity, the high degree of compliance with the programme and that many subjects asked spontaneously to continue with the exercise programme after the completion of the study. The LWHQ was validated with a subgroup of the SOLVD prevention trial of mean age years so it is not entirely surprising that it may not be appropriate for subjects some 20 years older. Many of the elderly subjects in our study while objectively quite limited had substantially reduced their activities and had become accustomed to and accepted their limitations. We suspect that such subjects may have achieved inappropriately low scores on the LWHQ so that they could not improve their score substantially. In addition, some questions of the LWHQ are not appropriate to elderly subjects as alluded to above. Similarly there was no change in NYHA Class despite the clear improvement in exercise capacity and subjective im-

6 70 ( ) A. Owen, L. Croucher European Journal of Heart Failure provement in quality of life. This reflects the inadequacy of the NYHA classification for symptom assessment of elderly patients with heart failure. It appears to us that such patients frequently reduce their activities to avoid symptoms and therefore render themselves less symptomatic. This study has demonstrated that elderly patients with heart failure are capable of benefitting from an appropriately designed exercise programme. They should therefore not be excluded from future large scale studies which are necessary to answer questions that cannot be addressed in a small short term study. In particular it needs to be established whether such a programme would have a beneficial effect on mortality and morbidity. If such a benefit were established the optimum duration and frequency of attendance would also need to be determined. The present study has demonstrated a high level of compliance but it is not known whether this would be maintained if elderly subjects were asked to attend for a longer period, possibly for the rest of their life. The safety of asking frail high risk patients to increase their physical activity Ž both supervised and unsupervised. over a longer period requires further assessment. Acknowledgements The authors are grateful to Zeneca Pharmaceuticals for a grant which helped support this study. The study would not have been possible without the dedicated assistance of nursing staff ŽM. Dhupa, B. Gray, W. Marsh and P. Williams., clerical staff ŽS. Brown, R. Gorham and R. Hill., physiotherapy assistants ŽJ. Hazelgrove and D. Lee-Frost. and C. Martin Žexercise physiologist. to whom the authors are most grateful. Finally and most importantly the study would not have been possible without the patients who volunteered to take part and their participation is gratefully acknowledged. References 1 European Heart Failure Training Group. Experience from controlled trials of physical training in chronic heart failure: protocol and patient factors in effectiveness in the improvement in exercise tolerance. Eur Heart J 1998;19: Pieopoli MF, Flather M, Coats AJS. Overview of studies of exercise training in chronic heart failure: the need for a prospective randomised multicentre European trial. Eur Heart J 1998;19: Willenheimer R, Erhardt L, Cline C, Rydberg E, Isaelsson B. Exercise training in heart failure improves quality of life and exercise capacity. Eur Heart J 1998;19: Kannel WB, Belander AG. Epidemiology of heart failure. Am Heart J 1991;121: Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomised, double-blind, placebocontrolled trial of pimobendan. Am Heart J 1992;124: Rector TS, Kubos H, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to Enalapril or placebo. Am J Cardiol 1993;71: Coats AJ, Adamopoulos S, Radaelli A et al. Controlled trial of physical training in chronic heart failure. Exercise performance, haemodynamics, ventilation and autonomic function. Circulation 1992;85: Bell J, Coats AJS, Hardman AE. Exercise testing and prescription In: Coats AJS, McGee H, Stokes H, Thompson D, editors BACR guidelines for cardiac rehabilitation. 9 Owen A. Diagnosis of heart failure in the elderly in general practice. Heart Failure ; Kavanagh T, Myers MG, Baigrie RS, Mertens DJ, Sawyer P, Shepherd RJ. Quality of life and cardiorespiratory function in chronic heart failure: effects of 12 months aerobic training. Heart 1996;76:42 49.