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04 599-604.qxdDocumento descargado de http://www.elsevier.es el 04/08/2009. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato.
Benefits of a Home-Based Pulmonary Rehabilitation Program
for Patients With Severe Chronic Obstructive Pulmonary Disease
Vanessa Regiane Resqueti,a Amaia Gorostiza,b Juan B. Gladis,b Elena López de Santa María,b Pere Casan Clarà,aand Rosa Güell Rousa aHospital de la Santa Creu i de Sant Pau, Facultad de Medicina, Universidad Autónoma de Barcelona, Barcelona, SpainbHospital de Cruces, Barakaldo, Vizcaya, Spain OBJECTIVE: The benefits of a domiciliary program of
Key words: Chronic obstructive pulmonary disease (COPD).
pulmonary rehabilitation for patients with severe to very
Pulmonary rehabilitation, domiciliary. Health-related quality of severe chronic obstructive pulmonary disease (COPD) are
uncertain. We aimed to assess the short- and medium-term
efficacy of such a program in this clinical setting.
PATIENTS AND METHODS: Patients with severe COPD (stages
Beneficios de un programa de rehabilitación III-IV, classification of the Global Initiative for Chronic
Obstructive Lung Disease) and incapacitating dyspnea
(scores 3-5, Medical Research Council [MRC] scale) were
randomized to a control or domiciliary rehabilitation group.
OBJETIVO: Los beneficios de la rehabilitación respiratoria
The 9-week supervised pulmonary rehabilitation program
domiciliaria (RRD) en pacientes con enfermedad pulmonar
included educational sessions, respiratory physiotherapy, and
obstructiva crónica (EPOC) de grado grave-muy grave son
muscle training in weekly sessions in the patient´s home. We
controvertidos. Nuestro objetivo ha sido evaluar la eficacia a
assessed the following variables at baseline, 9 weeks, and 6
corto y medio plazo de un programa de RRD en pacientes
months: lung function, exercise tolerance (3-minute walk
con EPOC grave.
test), dyspnea (MRC score), and health-related quality of
PACIENTES Y MÉTODOS: Se trata de un estudio prospectivo y
life with the Chronic Respiratory Questionnaire (CRQ).
aleatorizado en pacientes con EPOC grave (estadios III y IV
RESULTS: Thirty-eight patients with a mean (SD) age of
de la clasificación GOLD) y disnea invalidante —puntuación
68 (6) years were enrolled. The mean MRC score was
de 3 a 5 en la escala del Medical Research Council (MRC)—,
4 (0.8) and mean forced expiratory volume in 1 second was
distribuidos en grupo control y grupo RRD. El programa de
29% of reference. Twenty-nine patients completed the
rehabilitación respiratoria fue de 9 semanas y consistía en
study (6 months). Distance covered on the walk test
educación, fisioterapia respiratoria y entrenamiento muscular
increased significantly in the rehabilitation group (P=.001)
con supervisión semanal en domicilio. Evaluamos en situación
and the difference was maintained at 6 months. Dyspnea
basal, a las 9 semanas y a los 6 meses la función pulmonar, la
also improved significantly with rehabilitation (P≤.05), but
capacidad de ejercicio (prueba de la marcha de 3 min), la dis-
the reduction was not evident at 6 months. Statistically
nea (MRC) y la calidad de vida relacionada con la salud, de-
significant improvements in symptoms related to 2 CRQ
terminada con el Chronic Respiratory Questionnaire (CRQ).
domains were detected between baseline and 9 weeks:
RESULTADOS: Participaron en el estudio 38 pacientes, con una
dyspnea (3.1 [0.8] vs 3.6 [0.7]; P=.02) and fatigue (3.7 [0.8]
edad media ± desviación estándar de 68 ± 6 años (puntuación
vs 4.2 [0.9]; P=.002). A clinically relevant but not
MRC: 4 ± 0,8; volumen espiratorio forzado en el primer se-
statistically significant change in mastery over disease was
gundo: 29% del valor de referencia), y 29 completaron el se-
detected (from 4.3 to 4.9). All improvements were main-
guimiento a los 6 meses. En el grupo RRD se incrementó signi-
tained at 6 months.
ficativamente la distancia recorrida en la prueba de la marcha
CONCLUSIONS: Home-based pulmonary rehabilitation for
de 3 min (p = 0,001), resultado que se mantuvo a los 6 meses.
patients with severe to very severe COPD and severe
La disnea mejoró significativamente tras la RRD (p ≤ 0,05),
functional incapacity leads to improvements in exercise
pero dicha mejoría desapareció a los 6 meses. Se observó una
tolerance and health-related quality of life that are main-
mejoría clínica y estadísticamente significativa en 2 dominios
tained at 6 months.
del CRQ, el de disnea (3,1 ± 0,8 frente a 3,6 ± 0,7; p = 0,02) y el
de fatiga (3,7 ± 0,8 frente a 4,2 ± 0,9; p = 0,002), y tan sólo clí-
nica (4,3 frente a 4,9) en el control de la enfermedad, mejorías
The preliminary results of this study were first presented at the annual European que se mantuvieron a los 6 meses.
Respiratory Society Congress, September 2005 in Copenhagen, Denmark.
CONCLUSIONES: La RRD en pacientes con EPOC grave-
The study was partially funded by the Breathe Network (Red Respira) muy grave y alta incapacidad funcional aporta beneficios en
of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR). la calidad de vida relacionada con la salud y la capacidad de
ejercicio, que pueden mantenerse hasta los 6 meses.
Correspondence: Dra. R. Güell Rous.
Área de Rehabilitación-Departamento de Neumología. Palabras clave: Enfermedad pulmonar obstructiva crónica
Hospital de la Santa Creu i de Sant Pau.
Sant Antoni M. Claret, 167. 08025 Barcelona. España.
(EPOC). Rehabilitación respiratoria domiciliaria. Calidad de vida relacionada con la salud. Capacidad del ejercicio. Manuscript received September 25, 2006. Accepted for publication March 20, 2007.
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REGIANE RESQUETI V ET AL. BENEFITS OF A HOME-BASED PULMONARY REHABILITATION PROGRAM FOR PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE Introduction
twice a day, and 80 µg of ipratropium bromide 3 times a day.
Ten days of antibiotic treatment (amoxicillin–clavulanic acid, Chronic obstructive pulmonary disease (COPD), an moxifloxacin, or levofloxacin) and oral corticosteroids (30 mg important cause of morbidity and mortality worldwide, of prednisone and a regimen of decreasing doses) were prescribed is characterized by progressive airflow limitation that is in case of an exacerbation. An exacerbation was defined as the partially reversible.1 As the disease advances, some appearance of cough with increased sputum volume or purulence patients develop systemic manifestations, among them and increased dyspnea, in accordance with the criteria of exercise intolerance, peripheral muscle dysfunction, pulmonary hypertension, malnutrition, and exacerbationsthat often require hospitalization.2 Dyspnea, which is the main symptom, causes progressive loss of functional Intensive phase. The period of intense care (with or without capacity until even the simplest activities of daily living a pulmonary rehabilitation program) was 9 weeks. During the are affected. This leads to loss of autonomy and the first phase, all patients in both groups attended educational and development of a considerable degree of disability, with physical therapy sessions on 3 different days. Each day´s session consequent psychosocial changes and loss of quality of consisted of 1 hour of patient education and 30 minutes of conventional, individualized physical therapy, including the Pulmonary rehabilitation has been shown, with a high learning of diaphragmatic breathing, pursed lips breathing, and level of evidence, to provide benefits in terms of exercise techniques to remove secretions if indicated. tolerance and health related quality of life (HRQL).4 Most From the second week, patients in the control group were pulmonary rehabilitation programs are carried out encouraged to carry out the respiratory physiotherapy exercisesat home and to walk, but no supervision was given. They were in hospital or physical therapy settings and are asked to record their activity each week on a special sheet. multidisciplinary.5,6 Home-based or mixed home-and- Patients in the pulmonary rehabilitation group participated hospital–based programs have proven to be similarly in 3 hospital training sessions in the second week. In these effective to hospital programs, and their benefits even sessions they learned to do the exercises they were to continue seem to be more lasting.7-10 However, most studies have doing at home. Each session included a) leg exercises on a been done in patients with moderate COPD with acceptable stationary cycle, performed in intervals consisting of 5 minutes levels of autonomy and dyspnea that is not incapacitating; of exercise at a maximum load of 30 W (because the home very little research has been done on home-based programs exercise cycle was a simple one) separated by 2 minutes of in patients with severe airflow limitation.9 rest, and starting with a training period of 5 to 15 minuteswhich was later lengthened according to tolerance; Our objective was to assess the efficacy of a home b) exercises to strengthen the arms in sessions of 15 to 30 pulmonary rehabilitation program in patients with severe minutes, initially without weights and with gradual increases to very severe COPD—stages III-IV according to the in load according to tolerance; and c) inspiratory muscle criteria of the Global Initiative for Chronic Obstructive training with the Threshold IMT (Respironics, Cedar Grove, Lung Disease (GOLD)—and who also have incapacitating New Jersey, USA) in sessions of 15 minutes at a steady load corresponding to 30% of maximal inspiratory pressure.
Between the third and ninth weeks the patients followed theprogram at home 5 times per week for a period of 1.5 hours, Patients and Methods
following the exercise protocol learned in the hospital. Theyfilled in a diary during this period and a physical therapist visited them at home on Mondays and telephoned on Fridays Patients diagnosed with severe or very severe COPD (GOLD to check compliance and resolve doubts or problems related stages III-IV) attending an outpatient clinic at either of 2 university hospitals in Spain (Hospital de Cruces in Barakaldo, near Bilbao, Patients on home oxygen therapy adjusted flow to maintain and Hospital de la Santa Creu i de Sant Pau in Barcelona) were oxygen saturation (SpO ) above 90%. Patients who were not enrolled prospectively whether or not they were on home oxygen using home oxygen therapy but who developed desaturation therapy if they met the following criteria: age less than 80 years; during exercise (SpO <90%) were prescribed an oxygen dyspnea assessed as 3 or more on the Medical Research Council concentrator for use while exercising at home and they also (MRC) scale; and difficulty coming to the hospital because adjusted flow as appropriate for maintaining the same level. of serious shortness of breath or problems related to place of Patients in both groups could reach the physician supervising residence. Patients were excluded if they had heart disease or any other type of disease that limited exercise tolerance, did not Maintenance phase. After the tenth week and until the end have a positive attitude toward the program, or had some form of the sixth month, patients in the home pulmonary rehabilitation of mental disability that prevented participation. The study was group were advised to continue exercising according to the same approved by the ethics committees of both hospitals and written regimen. The physical therapist telephoned each patient once a informed consent was obtained from all patients. month and offered to arrange a visit with the supervising physicianif there were any signs of possible exacerbation. Patients in both groups saw the respiratory physician for a check-up every 2 months; that specialist also saw them in case This was a prospective, controlled trial in which patients were randomized to a control group or a home pulmonary rehabilitationgroup. Randomization was carried out by assignments placed All patients in both groups received the same medical Lung function tests. Spirometry parameters—forced vital treatment: 50 µg of salmeterol twice a day, 500 µg of fluticasone capacity, forced expiratory volume in 1 second (FEV ), the Documento descargado de http://www.elsevier.es el 04/08/2009. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato.
REGIANE RESQUETI V ET AL. BENEFITS OF A HOME-BASED PULMONARY REHABILITATION PROGRAM FOR PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE ratio of FEV to forced vital capacity—and maximum voluntary ventilation were measured with a Datospir 91 (SibelMed, Barcelona, Spain). The method and referencevalues were those recommended by the Spanish Society ofPulmonology and Thoracic Surgery (SEPAR).12,13 Maximum expiratory and inspiratory pressures were measured with amanometer (model 163, SibelMed, Barcelona, Spain)14 andthe reference values were those of Morales et al15 for a Mediterranean population. Arterial blood gas parameters (pH, PaO , and PaCO ) were measured at rest, according to SEPAR recommendations,16 with an ABL 500 device (Radiometer,Copenhagen, Denmark). Three-minute walk test. The 3-minute walk test17 carried out in a corridor 25 m long was used in each hospital to assess exercise tolerance. The patients were asked to walk from one end of the corridor to the other, trying to cover the greatest distance possible in 3 minutes. SpO and heart rate were measured continuously with a pulse oximeter (Pulsox5, Konica-MinoltaAVL, Diessenhofen, Switzerland). At the beginning and end of Figure 1. Changes in distance covered in the 3-minute walk test from baseline
to 9 weeks and after 6 months. PR indicates pulmonary rehabilitation.
every test the level of dyspnea was recorded on a modified Borg *Significant improvement.
scale of 0 to 10.18 Patients whose SpO fell below 90% during the walk test were administered oxygen in order to preventdesaturation. For patients who were already on oxygen therapy,the flow rate was adjusted as ordered by the physician to maintaina level of SpO of at least 90%. Dyspnea and HRQL. Shortness of breath during activities of daily living was quantified from 1 to 5 on the MRC scale.19 Forty-two consecutive patients met the inclusion criteria HRQL was assessed with the Chronic Respiratory Questionnaire and 38 were enrolled (35 men, 3 women). The mean (SD) (CRQ), using a validated Spanish translation.20 The questionnaire age was 69 (4) years and the mean FEV was 29% of contains 20 questions in 4 domains: dyspnea (5 questions), fatigue predicted. One of the 4 patients who did not participate (4 questions), emotional function (7 questions), and mastery was hospitalized for exacerbation when starting the over disease (4 questions). Each domain was scored on a scale program; the other 3 patients did not cooperate adequately. of 7 points (the higher the score, the better the HRQL). A clinically Fifty-five percent of the 38 patients were receiving significant improvement was defined as an increase of 0.5 points oxygen therapy 24 hours a day. The patients were randomized to the control or home pulmonary rehabilitationgroup (19 each); the baseline characteristics of patients were similar in each group (Table 1). Of the 38 patients Descriptive statistics were compiled during the first part of who entered the program, only 29 completed the 6 months the study. In the second part comparisons were performed to (15 in the control group and 14 in the rehabilitation group).
test hypotheses. Quantitative variables are expressed as the Four patients in the control group stopped following arithmetic mean (SD). Baseline measures were compared with recommendations, and in the rehabilitation group 2 patients the Student t test; qualitative variables were compared with the χ2 test. Outcomes in the different groups were compared during No significant changes in lung function or maximal the study period by 2-factor analysis of variance of a time factor respiratory pressures were observed in either group. Patient (2 repeated measures: baseline and end point) and a treatmentfactor (2 independent measures, rehabilitation and control). All performance on the 3-minute walk test improved analyses were carried out with the SPSS statistical package, significantly only in the pulmonary rehabilitation group version 11.5 for Windows. A 2-tailed significance level of 5% (from 148 m before the program to 167 m afterwards; (P<.05) was used in all cases.
P=.001) and the difference was still evident at 6 months(Figure 1). No significant differences in dyspnea assessedon the Borg scale, in heart rate, or in SpO at the end of the walk test were observed in either group. Dyspnea measured on the MRC scale improved Lung Function Variables and Patient Characteristics*
significantly: patients in the rehabilitation group had less Control Group
shortness of breath at 9 weeks than did patients in the Variables
control group (3.1 [0.7] vs 3.4 [0.8], respectively; P<.05),but the improvement was not maintained at 6 months.
Pulmonary rehabilitation patients also experienced statistically significant improvement in 2 CRQ domains: dyspnea (P=.02) and fatigue (P=.002) after 9 weeks in the intensive program. That improvement was still evident at 6 months. In the domain termed mastery of disease only *Data are expressed as mean (SD). FEV indicates forced expiratory volume in 1 a clinically significant improvement was evident at 9 weeks second; FVC, forced vital capacity; BMI, body mass index; MRC, Medical Research (4.21 vs 4.74) and it was maintained at 6 months (Figure 2 Council; PR, pulmonary rehabilitation.
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REGIANE RESQUETI V ET AL. BENEFITS OF A HOME-BASED PULMONARY REHABILITATION PROGRAM FOR PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE therapy 24 hours a day. Finally, our program was lessintense than most of the other programs that have alsoreported successes and ours did not last as long as thoseearlier programs. The training workload is usually more than 30 W and programs usually last longer than 9 weeks.7,8When Hernández et al10 analyzed a longer program that was otherwise comparable to ours, but in patients with a less severe degree of obstruction, their findings indicated there were considerable benefits in HRQL and exercisetolerance. Very few studies have assessed the possibility of home training in patients with a level of disease severity thatwas similar to the level in our study. The study most similar to ours was that of Wedzicha et al,9 who assessed the effect of peripheral muscle training and aerobic exercise in COPDpatients grouped according to baseline dyspnea measured on the MRC scale. Patients with a score of 5 showed no changes in either exercise tolerance or HRQL after the home program, whereas those with scores of 3 to 4 did benefit after a hospital-based program. Our results are notconsistent with those, as we did observe a beneficial effecteven though our patients had more severe COPD (FEV , Figure 2. Changes, in the home pulmonary rehabilitation group, on 4 domains
29% of predicted or less, vs 37% of predicted in the study of the Chronic Respiratory Questionnaire (CRQ) from baseline to 9 weeks
of Wedzicha and colleagues); it is true, however, that our of training and after 6 months.
*Statistically significant difference. †Clinically significant difference.
patients had a slightly lower mean MRC score for dyspnea,at 4 (0.8). As mentioned by Wedzicha and colleagues, thefactors that might have influenced the lack of response totraining in those patients with a higher level of dyspnea Discussion
were a lower intensity of training than the level applied Our findings show that a home pulmonary rehabilitation in their group with less dyspnea and the short duration of program for patients with very severe COPD and the program. In our program the duration of treatment was incapacitating shortness of breath improves exercise similar but the intensity increased each week, as the amount tolerance, dyspnea, and certain aspects of HRQL and that of time spent on the exercise cycle grew longer and more the benefits are partially maintained 6 months after the weight was used during arm exercises. Incidentally, we program ends. Previous studies of home pulmonary observed that the 2 patients of the 19 in our rehabilitation rehabilitation programs have shown clear improvements group who had a baseline dyspnea score of 5 both increased in exercise tolerance and HRQL.7-10 Few of those studies, their distance walked in 3 minutes (by 20 m and 35 m, however, are comparable to ours for a variety of reasons.
respectively) after the 9-week program; in contrast, the 2 First there is the issue of severity of disease. Most studies control group patients who also had baseline dyspnea have enrolled patients with an FEV over 40% of predicted scores of 5 increased their distances by only 2 m after 9 and a lesser degree of dyspnea,10 whereas our patients had weeks. Had the sample of patients with MRC ratings of severe obstruction, with an FEV less than 30% of predicted, 5 been larger, we might have been able to confirm that and incapacitating dyspnea as shown by a mean MRC rating of 4 (0.8). Second, over half the patients in our study Our patients who received 9 weeks of training had respiratory insufficiency requiring home oxygen significantly increased the distances walked in 3 minutes Changes in Measures After 9 Weeks of Exercise and After 6 Months of Follow-Up*
Home PR Group
*Results are expressed as means (SD).
CRQ indicates Chronic Respiratory Questionnaire; BMI, body mass index; MRC, Medical Research Council; PR, pulmonary rehabilitation.
†Statistically significant difference, analysis of variance. ‡Clinically significant difference. Documento descargado de http://www.elsevier.es el 04/08/2009. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato.
REGIANE RESQUETI V ET AL. BENEFITS OF A HOME-BASED PULMONARY REHABILITATION PROGRAM FOR PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE by a mean 18.9 m and the improvement was maintained An interesting finding of our study is the confirmation at 6 months. Redelmeier et al22 demonstrated a clinically that benefits of the pulmonary rehabilitation program were significant increase of 54 m in the 6-minute walk test; we maintained at 6 months even with such a simple intervention might therefore suppose that an increase of nearly 19 m as a monthly telephone call. Few studies have been able in the 3-minute walk test would have some clinical to demonstrate the long-term maintenance of benefits, significance, consistent with the improvement in dyspnea beyond 1 or 2 years.5,28,29 All such studies have applied score. We used a shorter walk test in this study for 2 reasons.
more intensive approaches to maintenance than the one On the one hand, our patients had very severe dyspnea used by our group, though it must be remembered that the and were in very poor physical condition; consequently levels of COPD severity of subjects in those studies were many were unable to complete the 6-minute walk test. On the other hand, short tests have proven valid for patients A limitation of our study was the fact that the respiratory with COPD.8,17 Stribjos et al8 observed significant medicine specialist responsible for the program was not improvement in a 4-minute walk test and in strength during blinded as to group assignment. Another feature that might a cycle ergometer test; the duration of that study was longer be considered a limitation was the high rate of abandonment than ours but our results are consistent with it. during the 6-month follow-up period. However, that rate The improvement in our patients’ exercise tolerance is similar to the ones reported for other studies.7,8,10 Patients after muscle training can be attributed to several may have stopped exercising because of lack of motivation mechanisms. The first is related to physiological changes and/or scarce support from the physical therapist, who on both a muscular and cardiopulmonary level. Change only made a monthly telephone call. Outcomes might have or lack of it appears to be related to the intensity of been better if there had been greater contact with the exercise, but findings have been contradictory: some supervisor of the program, although given the severity of authors consider it necessary to exercise intensely to disease in our subjects, the rate of withdrawal would be obtain benefit,23 whereas others have demonstrated expected to be higher than in a group of less seriously ill changes in cardiovascular24 and muscle structure and function25 even with a low level of exercise. Our patients In summary, our results confirm that a pulmonary exercised at very low levels. No improvements in rehabilitation program that includes low-intensity training physiological parameters (heart rate and SpO ), lung of several muscle groups improves exercise tolerance, function parameters, or respiratory pressures were evident.
dyspnea, and certain HRQL parameters in COPD patients Thus, we cannot attribute the increased exercise tolerance who are severely ill. Furthermore, these benefits are partially to an improvement in cardiopulmonary response. The maintained at 6 months with a minimal approach to second mechanism would be defined by changes in muscle maintenance. Our view is that further studies with a larger structure and function after training. We cannot know number of patients are needed to confirm these findings whether our patients´ increased exercise tolerance was and that such studies should include other outcome attributable to such changes, as we did not carry out measures, such as the number of exacerbations or the muscle biopsies or measure blood levels of lactic acid.
A third mechanism, as demonstrated by various authors,points to an effect of muscle training on neuromuscular Acknowledgments
coordination.26 Improvement in this respect wouldincrease an individual´s ability to carry out activities of We thank Fátima Morante and Mercedes Sangenis for all their daily living, particularly for the most sedentary patients.
support while implementing the program; the lung function team Our patients´ increased exercise tolerance might be at Hospital de la Santa Creu i de Sant Pau in Barcelona; and attributable to this factor. The improvements in the Guilherme Fregonezi for his help in preparing this article. dyspnea and fatigue domains of the CRQ might also beindirect indications of peripheral muscle improvementafter exercise. A fourth mechanism to which improvedexercise tolerance in COPD patients is attributed is that REFERENCES
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A Useful Glossary of Cancer Related Terms Adjuvant therapy - Treatment that is added to increase the effectiveness of a primary therapy. It usually refers to chemotherapy or radiation added after surgery to increase the chances of curing the disease or keeping it in check locally. Advanced cancer - A stage of cancer in which the disease has spread from the primary site to other parts