Andrew L. Ries

Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease.

The chronic obstructive pulmonary diseases are major causes of disability and death [1-3]. Health statistics underestimate the prevalence of these diseases because of difficulties in definition and recognition and because of misclassification [4]. Although standard medical therapy can alleviate symptoms, many patients with these diseases must cope with the distressing symptom of breathlessness that results from a chronic, irreversible, and disabling disease. These patients may use services in physician offices, emergency departments, hospitals, and intensive care units, in part because of a lack of understanding and inability to cope with frightening and disabling symptoms. Since a comprehensive care program for patients with chronic obstructive pulmonary disease was first described [5], pulmonary rehabilitation has become an established way to enhance standard therapy to control symptoms, optimize functional capacity, and reduce the medical and economic burdens of patients with disabling chronic lung diseases [6-12]. Comprehensive programs usually include education, instruction in respiratory and chest physiotherapy techniques, psychosocial support, and exercise training [13]. The primary goal of rehabilitation is to restore the patient to the highest possible level of independent function. This is accomplished by helping patients to become more knowledgeable about their disease, more actively involved in their own health care, more independent in performing daily activities, and less dependent on others, including health professionals. Previous studies have shown important benefits of pulmonary rehabilitation, including increased exercise tolerance and quality of life and a decreased number of symptoms and use of health care services [7]. However, many of these findings are based on small numbers of patients and on observational, nonrandomized studies. We compared the effects of comprehensive pulmonary rehabilitation on both physiologic and psychosocial outcomes with the effects of education alone. Our study featured random assignment and long-term, 6-year follow-up. Methods Patients For 18 months, 352 patients with chronic obstructive pulmonary disease were screened for the study; 128 met entry criteria and were randomly assigned to either the comprehensive pulmonary rehabilitation program or an education program (control group). Patients were recruited through mechanisms similar to those used in regular clinical pulmonary rehabilitation, including written and personal contact with physicians and direct advertisement to the general public for persons with breathlessness. Nine patients who initially agreed to participate (6 in the rehabilitation group and 3 in the education group) but who withdrew from the study before completing 2 weeks of the interventions were considered to be pretreatment drop-outs. Reasons for dropping out included concurrent illness (four patients), a too-large time commitment (2 patients), and no clear explanation (3 patients). Patients who dropped out and those who remained in the study did not differ. The remaining 119 patients comprised 32 women and 87 men. The following were the inclusion criteria: 1. Clinical diagnosis of mild to severe chronic obstructive pulmonary disease that was confirmed by history, physical examination, spirometry, measurement of arterial blood gases, and chest roentgenograms. Patients with diagnoses of emphysema, chronic bronchitis, or asthmatic bronchitis were accepted. Patients with primarily acute, reversible airway disease (asthma) but no chronic airflow obstruction were excluded. 2. Stable condition while the patient was receiving an acceptable medical regimen and was under the care of a primary care provider. Patients without a primary care physician who presented for evaluation were referred for appropriate evaluation and treatment before they enrolled in the study. 3. No other significant disabling lung disease, serious heart problems, or other medical condition that would interfere with the patients participation. Current smokers were not excluded if they showed a commitment to quitting smoking before enrollment. Smoking cessation counseling was incorporated into the rehabilitation program for patients assigned to that group. Experimental Design All eligible patients were randomly assigned to participate in either the comprehensive pulmonary rehabilitation program (n = 57) or the education program (n = 62). The randomization scheme was fixed before the trial with a block size of 8. Assignment was determined by a table of random numbers and was indicated on cards placed in sequentially numbered envelopes that were kept in a central office separate from the study site. Clinical personnel were unaware of the randomization scheme. After a patient agreed to enroll and signed the consent form approved by the University of California, San Diego, Human Subjects Committee, the central office was contacted by telephone and the next numbered envelope was opened. Interventions Pulmonary Rehabilitation Program The comprehensive rehabilitation program included two phases. Phase I (core program) consisted of twelve 4-hour sessions given over 8 weeks. Each session included two periods of classroom or group support and supervised exercise training. The rehabilitation program included four main components: 1. Education. Groups of three to six patients were taught by experienced pulmonary rehabilitation staff and selected guest speakers. Topics included the following: How Normal Lungs Work, What Is Chronic Obstructive Pulmonary Disease?, Medications, Nutrition, Oxygen Therapy, Coping with Stress, Energy-saving Techniques, Self-Care Tips, Travel, Pollution and Environmental Hazards, When To Call Your Doctor, Smoking Cessation Techniques, Planning a Daily Schedule, and Breathing Techniques. 2. Physical and respiratory care instruction. Patients received individual instruction in respiratory care and chest physiotherapy techniques such as postural drainage, pursed lip and diaphragmatic breathing, oxygen therapy, and proper use of respiratory therapy equipment. 3. Psychosocial support. Patients and staff met in weekly group sessions facilitated by a psychiatrist. Spouses or partners of the patients were encouraged to attend. Sessions focused on difficulties commonly faced by patients, such as depression, anxiety, fear, and family or social problems. Relaxation techniques were introduced to help patients better cope with the emotional stress of dyspnea. 4. Supervised exercise training. After the baseline exercise test, each patient received an individualized exercise prescription based on the maximum, symptom-limited level [14]. Patients with severe hypoxemia (Pao2 < 55 mm Hg at rest or < 50 mm Hg with exercise) were trained using supplemental oxygen. The primary exercise-training modality was walking. Training emphasized steady-state exercise consisting of continuous walking at the highest tolerated symptom-limited level for as long as 30 minutes. Patients were initially trained to walk on a motor-driven treadmill under supervision. The staff then instructed patients in translating the target treadmill speed to a pace for free walking. Patients were asked to walk at home at least twice daily and to keep a training log of time, distance, pace (steps per minute), and perceived symptoms of breathlessness and muscle fatigue. Patients were also instructed and trained in upper-extremity exercise using an isokinetic upper-body ergometer during supervised sessions and a progressive program of arm lifts with weights for home training [15]. Patients were asked to do upper-extremity training daily and to keep a daily log. Phase II of the rehabilitation program involved monthly follow-up visits for 1 year. These visits provided reinforcement after the core phase of the program. These sessions included a supervised period of exercise, group sessions to discuss progress and problems, and the introduction of maintenance techniques. Education Control Program The goal of the education program was to conduct a series of health education classes that would provide information similar to that provided in the rehabilitation program, but in a shorter and less intensive program without the behavioral components, individualized instruction, and supervised exercise training. Patients in the education group attended four 2-hour sessions scheduled biweekly for 8 weeks. Each group consisted of approximately 10 to 15 patients. At the beginning of each session, a videotape describing some aspect of chronic obstructive pulmonary disease management was presented [Pulmonary Self-Care Series, Encyclopedia Britannica, Vision Multimedia Communications, Inc., Winter Park, Florida]. The four-part videotape series included the following programs: 1) Learning To Live with a Breathing Problem; 2) Building Your Strength and Endurance; 3) You Can Do It: Clearing Your Airways; and 4) Learning To Breathe Better. Patients also completed life events [16], social support [17], health locus of control [18], and sense of coherence [19] questionnaires and a semistructured smoking interview. The patients then participated in a group discussion about either the material covered in the videotape or the questionnaires. The final hour of the session included a lecture followed by a question and answer period presented by professionals in the fields of pulmonary medicine, pharmacology, respiratory therapy, and nutrition. Assessment Each patient had physiologic and psychosocial function evaluation before intervention (baseline), immediately after the program ended (2 months), and at regular intervals for 72 months. Physiologic measures, including laboratory pulmonary function and maximal treadmill exercise tests, were done 2, 12, 24, 48, and 72 months after the program began. Psychosocial measures and endurance exercise tests were done more frequently at 2, 6, 12, 18, 24, 36, 48, 60, and 72 months. Laboratory tests of pulmon

The minimal important difference of exercise tests in severe COPD

Our aim was to determine the minimal important difference (MID) for 6-min walk distance (6MWD) and maximal cycle exercise capacity (MCEC) in patients with severe chronic obstructive pulmonary disease (COPD). 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4–6 weeks of pre-trial rehabilitation, and 6 months after randomisation to surgery or medical care. The St Georges Respiratory Questionnaire (domain and total scores) and University of California San Diego Shortness of Breath Questionnaire (total score) served as anchors for anchor-based MID estimates. In order to calculate distribution-based estimates, we used the standard error of measurement, Cohens effect size and the empirical rule effect size. Anchor-based estimates for the 6MWD were 18.9 m (95% CI 18.1–20.1 m), 24.2 m (95% CI 23.4–25.4 m), 24.6 m (95% CI 23.4–25.7 m) and 26.4 m (95% CI 25.4–27.4 m), which were similar to distribution-based MID estimates of 25.7, 26.8 and 30.6 m. For MCEC, anchor-based estimates for the MID were 2.2 W (95% CI 2.0–2.4 W), 3.2 W (95% CI 3.0–3.4 W), 3.2 W (95% CI 3.0–3.4 W) and 3.3 W (95% CI 3.0–3.5 W), while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26±2 m for 6MWD and 4±1 W for MCEC for patients with severe COPD.

Minimally clinically important difference for the UCSD Shortness of Breath Questionnaire, Borg Scale, and Visual Analog Scale.

Dyspnea is a primary symptom of chronic lung disease and an important outcome measure for clinical trials. Several standardized measures have been developed to evaluate this important symptom and are being used increasingly in clinical trials. The minimally clinically important difference (MCID) is not well defined for these measures but is important in interpreting the clinical meaning of results of studies in this area. The purpose of this paper is to evaluate the MCID for three commonly used measures to assess dyspnea in chronic lung disease: UCSD Shortness of Breath Questionnaire (SOBQ), Borg Scale (Borg), and Visual Analog Scale (VAS). The analysis is based on a retrospective review of published trials evaluating the response to a pulmonary rehabilitation or exercise intervention that is known to produce modest, but clinically meaningful changes for such patients. Using a distribution-based approach based primarily on effect size, the recommended MCID for these measures are: 5-units for the SOBQ, 1-unit for the Borg scale, and approximately 10 to 20 units for the VAS.

Experimental evaluation of rehabilitation in chronic obstructive pulmonary disease : short term effects on exercise endurance and health status

Randomly assigned 119 adults with chronic obstructive pulmonary disease to an 8-week comprehensive rehabilitation program or to an 8-week education control program. Comprehensive pulmonary rehabilitation included education, physical and respiratory therapy instruction, psychosocial support, and supervised exercise training; education control included biweekly classroom instruction and discussions on respiratory therapy, medical aspects of lung disease, clinical pharmacology, and diet, but no exercise training. Both groups received extensive physiological and psychosocial evaluation before and after the intervention. Six months after enrollment, patients randomly assigned to the rehabilitation program showed significant increases in exercise endurance, whereas patients randomly assigned to control program showed nonsignificant increases. Improvement in self-efficacy was correlated with improvements in exercise endurance.

Self-Efficacy Expectations Predict Survival for Patients With Chronic Obstructive Pulmonary Disease

The validity of self-efficacy expectations as predictors of mortality was evaluated for 119 patients with chronic obstructive pulmonary disease (COPD). Patients completed 4 physiological measures that represent common clinical indicators of disease severity: (a) forced expiratory volume in 1 s (FEV1.0), (b) arterial blood gas measurement of resting partial pressure of oxygen (PaO2), (c) single-breath diffusing capacity (DLCO), and (d) maximum oxygen uptake (VO2max) during exercise. In addition, self-reported self-efficacy expectation for walking on a treadmill was measured. Self-efficacy was a significant univariate predictor of 5-year survival. However, when controlling for FEV1.0 in multivariate survival analysis, self-efficacy had only a marginal effect. We concluded that simple self-report scales could provide significant information about health status.

An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation

RATIONALE Pulmonary rehabilitation (PR) has demonstrated physiological, symptom-reducing, psychosocial, and health economic benefits for patients with chronic respiratory diseases, yet it is underutilized worldwide. Insufficient funding, resources, and reimbursement; lack of healthcare professional, payer, and patient awareness and knowledge; and additional patient-related barriers all contribute to the gap between the knowledge of the science and benefits of PR and the actual delivery of PR services to suitable patients. OBJECTIVES The objectives of this document are to enhance implementation, use, and delivery of pulmonary rehabilitation to suitable individuals worldwide. METHODS Members of the American Thoracic Society (ATS) Pulmonary Rehabilitation Assembly and the European Respiratory Society (ERS) Rehabilitation and Chronic Care Group established a Task Force and writing committee to develop a policy statement on PR. The document was modified based on feedback from expert peer reviewers. After cycles of review and revisions, the statement was reviewed and formally approved by the Board of Directors of the ATS and the Science Council and Executive Committee of the ERS. MAIN RESULTS This document articulates policy recommendations for advancing healthcare professional, payer, and patient awareness and knowledge of PR, increasing patient access to PR, and ensuring quality of PR programs. It also recommends areas of future research to establish evidence to support the development of an updated funding and reimbursement policy regarding PR. CONCLUSIONS The ATS and ERS commit to undertake actions that will improve access to and delivery of PR services for suitable patients. They call on their members and other health professional societies, payers, patients, and patient advocacy groups to join in this commitment.

Sleep-disordered Breathing in Hispanic/Latino Individuals of Diverse Backgrounds. The Hispanic Community Health Study/Study of Latinos

RATIONALE Hispanic/Latino populations have a high prevalence of cardiovascular risk factors and may be at risk for sleep-disordered breathing (SDB). An understanding of SDB among these populations is needed given evidence that SDB increases cardiovascular risk. OBJECTIVES To quantify SDB prevalence in the U.S. Hispanic/Latino population and its association with symptoms, risk factors, diabetes, and hypertension; and to explore variation by sex and Hispanic/Latino background. METHODS Cross-sectional analysis from the baseline examination of the Hispanic Community Health Study/Study of Latinos. MEASUREMENTS AND MAIN RESULTS The apnea-hypopnea index (AHI) was derived from standardized sleep tests; diabetes and hypertension were based on measurement and history. The sample of 14,440 individuals had an age-adjusted prevalence of minimal SDB (AHI ≥ 5), moderate SDB (AHI ≥ 15), and severe SDB (AHI ≥ 30) of 25.8, 9.8, and 3.9%, respectively. Only 1.3% of participants reported a sleep apnea diagnosis. Moderate SDB was associated with being male (adjusted odds ratio, 2.7; 95% confidence interval, 2.3-3.1), obese (16.8; 11.6-24.4), and older. SDB was associated with an increased adjusted odds of impaired glucose tolerance (1.7; 1.3-2.1), diabetes (2.3; 1.8-2.9), and hypertension. The association with hypertension varied across background groups with the strongest associations among individuals of Puerto Rican and Central American background. CONCLUSIONS SDB is prevalent in U.S. Latinos but rarely associated with a clinical diagnosis. Associations with diabetes and hypertension suggest a large burden of disease may be attributed to untreated SDB, supporting the development and evaluation of culturally relevant detection and treatment approaches.

Regular walking and long-term maintenance of outcomes after pulmonary rehabilitation.

BACKGROUND Empirical evidence supports the role of exercise as part of pulmonary rehabilitation in improving symptoms of breathlessness (dyspnea), health-related quality of life, and exercise tolerance among patients with chronic lung disease. However, many studies show that these initial benefits tend to diminish 12 to 18 months after rehabilitation. Given the importance of exercise (ie, walking) during rehabilitation, we examined whether patient adherence to regular walking enhanced the long-term maintenance of functional benefits gained from an 8-week pulmonary rehabilitation program. METHODS One hundred twenty-three patients with moderate to severe chronic lung disease completed an 8-week pulmonary rehabilitation program and participated in a 12-month maintenance intervention trial. Measures of weekly walking, lung function, self-efficacy for walking, dyspnea during activities of daily living, exercise capacity (6-minute walk test, 6MW), perceived breathlessness after the 6MW, and health-related quality of life were obtained at postrehabilitation, and at 6, 12, and 24 months after completing pulmonary rehabilitation. Regular walkers were defined as those active on most days or every single day of the week on the average throughout the 24-month period, whereas irregular walkers walked on some days, rarely, or not at all. RESULTS The effects of the maintenance program on average frequency of walking were nonsignificant, with 44% of the maintenance patients and 38% of the standard care patients classified as regular walkers. There were no significant differences between walking groups on gender, healthcare utilization over the 24-month follow-up period, and postrehabilitation measures of lung function, 6MW distance, perceived breathlessness after 6MW, health-related quality of life, dyspnea, or age. Repeated measures analyses of variance using a 2 x 4 mixed model approach were applied to examine group differences and changes in outcomes over time. Overall, participants decreased in 6MW distance (P <.001), reported increases in perceived breathlessness after the 6MW (P <.05), and decreased in overall health-related quality of life (P <.001) from postrehabilitation to 24 months. Regular walkers reported significantly better health-related quality of life (P <.05) as compared to irregular walkers, averaging across time points. Irregular walkers declined significantly more than regular walkers on measures of shortness of breath during activities of daily living (P <.01) and walking self-efficacy (P <.001) from postrehabilitation to 24 months. CONCLUSIONS Findings suggest that participation in regular exercise such as walking after completing pulmonary rehabilitation is associated with slower declines in overall health-related quality of life and walking self-efficacy as well as less progression of dyspnea during activities of daily living. Regular exercise after rehabilitation may be protective against increases in dyspnea symptoms and perceived limitations in walking which are both characteristic of progressing chronic lung disease.

Longitudinal change in the BODE index predicts mortality in severe emphysema.

RATIONALE The predictive value of longitudinal change in BODE (Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity) index has received limited attention. We hypothesized that decrease in a modified BODE (mBODE) would predict survival in National Emphysema Treatment Trial (NETT) patients. OBJECTIVES To determine how the mBODE score changes in patients with lung volume reduction surgery versus medical therapy and correlations with survival. METHODS Clinical data were recorded using standardized instruments. The mBODE was calculated and patient-specific mBODE trajectories during 6, 12, and 24 months of follow-up were estimated using separate regressions for each patient. Patients were classified as having decreasing, stable, increasing, or missing mBODE based on their absolute change from baseline. The predictive ability of mBODE change on survival was assessed using multivariate Cox regression models. The index of concordance was used to directly compare the predictive ability of mBODE and its separate components. MEASUREMENTS AND MAIN RESULTS The entire cohort (610 treated medically and 608 treated surgically) was characterized by severe airflow obstruction, moderate breathlessness, and increased mBODE at baseline. A wide distribution of change in mBODE was seen at follow-up. An increase in mBODE of more than 1 point was associated with increased mortality in surgically and medically treated patients. Surgically treated patients were less likely to experience death or an increase greater than 1 in mBODE. Indices of concordance showed that mBODE change predicted survival better than its separate components. CONCLUSIONS The mBODE demonstrates short- and intermediate-term responsiveness to intervention in severe chronic obstructive pulmonary disease. Increase in mBODE of more than 1 point from baseline to 6, 12, and 24 months of follow-up was predictive of subsequent mortality. Change in mBODE may prove a good surrogate measure of survival in therapeutic trials in severe chronic obstructive pulmonary disease. Clinical trial registered with www.clinicaltrials.gov (NCT 00000606).

Minimal clinically important difference for the UCSD Shortness of Breath Questionnaire.

PURPOSE A minimal clinically important difference (MCID) is important in evaluating clinical measures such as health-related quality of life (HRQOL) instruments. The purpose of this analysis is to evaluate MCID for the UCSD Shortness of Breath Questionnaire (SOBQ). METHODS We examined measures of disease-specific and generic HRQOL in 164 subjects with chronic lung disease before and after pulmonary rehabilitation. Subjects completed 2 disease-specific [SOBQ, Chronic Respiratory Questionnaire (CRQ)], and 2 generic HRQOL measures [RAND-36 and Quality of Well-Being Scale (QWB)]. The MCID was calculated using 3 methods: effect size, standard error of the measurement (SEM), and comparison between the SOBQ and CRQ Dyspnea scores. RESULTS HRQOL measures correlated moderately with measures of maximum exercise tolerance but not with lung function (FEV1, FVC). HRQOL and exercise capacity improved significantly after pulmonary rehabilitation. A change of 5 units for the SOBQ appears to be a reasonable MCID for this instrument. The calculated MCIDs for the CRQ (0.47/item) and QWB (0.031) were consistent with established change scores. CONCLUSIONS The MCID calculated using an SEM approach for the SOBQ, CRQ, and QWB meets clinical expectations for these instruments. HRQOL measures provide information that is complementary and distinct from physiological measures.