[black small square] EFFECTS OF WRITTEN ACTION PLAN ADHERENCE ON COPD EXACERBATION RECOVERY
Bischoff EWMA, Hamd DH, Sedeno M, Benedetti A, Schermer TRJ, Bernard S, Maltais F, Bourbeau J
Thorax. 2011;66:26-31. Published online first October 30, 2010; doi: 10.1136/thx.2009.127621
Background: The effects of written action plans on recovery from exacerbations of chronic obstructive pulmonary disease (COPD) have not been well studied. The aims of this study were to assess the effects of adherence to a written action plan on exacerbation recovery time and unscheduled healthcare utilisation and to explore factors associated with action plan adherence.
Methods: This was a 1-year prospective cohort study embedded in a randomised controlled trial. Exacerbation data were recorded for 252 patients with COPD who received a written action plan for prompt treatment of exacerbations with the instructions to initiate standing prescriptions for both antibiotics and prednisone within 3 days of exacerbation onset. Following the instructions was defined as adherence to the action plan.
Results: From the 288 exacerbations reported by 143 patients, start dates of antibiotics or prednisone were provided in 217 exacerbations reported by 119 patients (53.8% male, mean age 65.4 years, post-bronchodilator forced expiratory volume in 1 s (FEV1) 43.9% predicted). In 40.1% of exacerbations, patients adhered to their written action plan. Adherence reduced exacerbation recovery time with statistical (p = 0.0001) and clinical (-5.8 days) significance, but did not affect unscheduled healthcare utilisation (OR 0.94, 95% CI 0.49 to 1.83). Factors associated with an increased likelihood of adherence were influenza vaccination, cardiac comorbidity, younger age and lower FEV1 as percentage predicted.
Conclusions: This study shows that adherence to a written action plan is associated with a reduction in exacerbation recovery time by prompt treatment. Knowing the factors that are associated with proper and prompt utilisation of an action plan permits healthcare professionals to better focus their self-management support on appropriate patients.
Editor's Comment. Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a major impact on health status as well as healthcare costs; prompt recognition and treatment may produce useful improvements in both these areas. One possible way of intervening early in AECOPD is by providing written action plans to patients that list cardinal warning symptoms (increased dyspnea, sputum volume, sputum color) and direct intervention (antibiotics, systemic corticosteroids).
The current study examined an embedded cohort, in a larger clinical trial, and identified 288 exacerbations in 143 patients. Unfortunately 24.7% of these lacked sufficient data and were excluded. Of the remaining 217, the action plan was strictly adhered to in only 40.1% events, with a looser adherence definition increasing this to 60.3%. Comparing those who adhered to the written plan with those who did not, there was a significant reduction in the days it took to recover (5.8 days, P = .0001), and this was seen even in those who adhered to only part of the plan (antibiotics or corticosteroids). More severe disease (lower FEV1), previous influenza immunization (a possible motivation marker), and cardiac comorbidity and younger age, predicted greater adherence. Adherence did not correlate with healthcare use between exacerbations.
Overall this is good evidence in favor of such an approach, but the study is compromised by its lack of randomization and by a very large proportion that could not be included because of incomplete data. A more definitive study needs to be done, but this certainly seems to be a big step in the right direction. -SK
[black small square] A RANDOMISED TRIAL OF DOMICILIARY, AMBULATORY OXYGEN IN PATIENTS WITH COPD AND DYSPNOEA BUT WITHOUT RESTING HYPOXAEMIA
Moore RP, Berlowitz DJ, Denehy L, Pretto JJ, Brazzale DJ, Sharpe K, Jackson B, McDonald CF
Thorax. 2011;66:32-37. Published online first September 29, 2010; doi: 10.1136/thx.2009.132522
Background: Patients with chronic obstructive pulmonary disease (COPD) who are not severely hypoxaemic at rest may experience significant breathlessness on exertion, and ambulatory oxygen is often prescribed in this circumstance despite a lack of conclusive evidence for benefit. This study aimed to determine whether such patients benefit from domiciliary ambulatory oxygen and, if so, which factors may be associated with benefit.
Methods: This was a 12 week, parallel, double-blinded, randomised, placebo-controlled trial of cylinder air versus cylinder oxygen, provided at 6 l/min intranasally, for use during any activity provoking breathlessness. Patients underwent baseline measurements of arterial blood gases and lung function. Outcome measures assessed dyspnoea, health-related quality of life, mood disturbance, functional status and cylinder utilisation. Data were analysed on an intention-to-treat basis, p <= 0.05.
Results: 143 subjects (44 female), mean +/- SD age 71.8 +/- 9.8 years, forced expiratory volume in 1 s (FEV1) 1.16 +/- 0.51 litres, PaO2 9.5 +/- 1.1 kPa (71.4 +/- 8.5 mm Hg) were randomised, including 50 patients with exertional desaturation to <= 88%. No significant differences in any outcome were found between groups receiving air or oxygen. Statistically significant but clinically small improvements in dyspnoea and depression were observed in the whole study group over the 12 weeks of the study.
Conclusion: In breathless patients with COPD who do not have severe resting hypoxaemia, domiciliary ambulatory oxygen confers no benefits in terms of dyspnoea, quality of life or function. Exertional desaturation is not predictive of outcome. Intranasal gas (either air or oxygen) may provide a placebo benefit.
Editor's Comment. This study is important and highly relevant. It addresses a question dealt with daily in respiratory practice as well as in rehabilitation programs: should one prescribe oxygen supplementation to patients with chronic obstructive pulmonary disease (COPD) who have exertional dyspnea but no resting hypoxemia?
This study is large and suitably powered, with 143 patients with moderate to severe airflow obstruction, randomized to receive room air or oxygen intranasally at 6 L/min during all dyspnea-provoking activity, using identical appearing equipment. In keeping with earlier studies, this one confirms a lack of short-term benefit with supplemental oxygen-an observation that holds true even in the 50 patients who showed exertional desaturation accompanying their dyspnea. This lack of benefit was concordantly seen in several domains, and even subgroup analyses failed to identify any meaningful impact that might justify more targeted oxygen prescription. Not unexpectedly, significant but clinically small improvements in dyspnea and depression were observed in the whole study group, using oxygen or room air, over the 12 weeks of the study.
This study does not answer issues relating to the risk of cardiac events or long-term questions such as prolongation of survival, reduction of exacerbation frequency, or the risk of developing pulmonary hypertension. However, the biological possibility (and plausibility) of such benefit seems farfetched in the absence of the more likely short-term gains that this study was designed to identify. Clinical practice should be driven by studies such as this one. -SK
[black small square] EFFECTS OF AEROBIC AND RESISTANCE TRAINING ON HEMOGLOBIN A1C LEVELS IN PATIENTS WITH TYPE 2 DIABETES: A RANDOMIZED CONTROLLED TRIAL
Church TS, Blair SN, Cocreham S, Johannsen N, Johnson W
JAMA. 2010;304(20):2253-2262. doi:10.1001/jama.2010.1710
Context: Exercise guidelines for individuals with diabetes include both aerobic and resistance training although few studies have directly examined this exercise combination.
Objective: To examine the benefits of aerobic training alone, resistance training alone, and a combination of both on hemoglobin A1c (HbA1c) in individuals with type 2 diabetes.
Design, Setting, and Participants: A randomized controlled trial in which 262 sedentary men and women in Louisiana with type 2 diabetes and HbA1c levels of 6.5% or higher were enrolled in the 9-month exercise program between April 2007 and August 2009.
Intervention: Forty-one participants were assigned to the nonexercise control group, 73 to resistance training 3 days a week, 72 to aerobic exercise in which they expended 12 kcal/kg per week; and 76 to combined aerobic and resistance training in which they expended 10 kcal/kg per week and engaged in resistance training twice a week.
Results: The study included 63.0% women and 47.3% nonwhite participants who were a mean (SD) age of 55.8 years (8.7 years) with a baseline HbA1c level of 7.7% (1.0%). Compared with the control group, the absolute mean change in HbA1c in the combination training exercise group was -0.34% (95% confidence interval [CI], -0.64% to -0.03%; P = .03). The mean changes in HbA1c were not statistically significant in either the resistance training (-0.16%; 95% CI, -0.46% to 0.15%; P = .32) or the aerobic (-0.24%; 95% CI, -0.55% to 0.07%; P = .14) groups compared with the control group. Only the combination exercise group improved maximum oxygen consumption (mean, 1.0 mL/kg per min; 95% CI, 0.5-1.5, P < .05) compared with the control group. All exercise groups reduced waist circumference from -1.9 to -2.8 cm compared with the control group. The resistance training group lost a mean of -1.4 kg fat mass (95% CI, -2.0 to -0.7 kg; P < .05) and combination training group lost a mean of -1.7 (-2.3 to -1.1 kg; P < .05) compared with the control group.
Conclusions: Among patients with type 2 diabetes mellitus, a combination of aerobic and resistance training compared with the nonexercise control group improved HbA1c levels. This was not achieved by aerobic or resistance training alone.
[black small square] EFFECT OF AN INTENSIVE EXERCISE INTERVENTION STRATEGY ON MODIFIABLE CARDIOVASCULAR RISK FACTORS IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS: A RANDOMIZED CONTROLLED TRIAL: THE ITALIAN DIABETES AND EXERCISE STUDY (IDES)
Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S
Arch Int Med. 2010:170(20):1794-1803.
Background: This study aimed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity (PA) and improving hemoglobin A1c(HbA1c) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM).
Methods: Of 691 eligible sedentary patients with T2DM and the metabolic syndrome, 606 were enrolled in 22 outpatient diabetes clinics across Italy and randomized by center, age, and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling (exercise group) vs counseling alone (control group) for 12 months. End points included HbA1c level (primary) and other cardiovascular risk factors and coronary heart disease risk scores (secondary).
Results: The mean (SD) volume of PA (metabolic equivalent hours per week) was significantly higher (P < .001) in the exercise (total PA [nonsupervised conditioning PA + supervised PA], 20.0 [0.9], and nonsupervised, 12.4 [7.4]) vs control (10.0 [8.7]) group. Compared with the control group, supervised exercise produced significant improvements (mean difference [95% confidence interval]) in physical fitness; HbA1c level (-0.30% [-0.49% to -0.10%]; P < .001); systolic (-4.2 mm Hg [-6.9 to -1.6 mm Hg]; P = .002) and diastolic (-1.7 mm Hg [-3.3 to -1.1 mm Hg]; P = .03) blood pressure; high-density lipoprotein (3.7 mg/dL [2.2 to 5.3 mg/dL]; P < .001) and low-density lipoprotein (-9.6 mg/dL [-15.9 to -3.3 mg/dL]; P = .003) cholesterol level; waist circumference (-3.6 cm [-4.4 to -2.9 cm]; P < .001); body mass index; insulin resistance; inflammation; and risk scores. These parameters improved only marginally in controls.
Conclusions: This exercise intervention strategy was effective in promoting PA and improving HbA1c and cardiovascular risk profile. Conversely, counseling alone, though successful in achieving the currently recommended amount of activity, was of limited efficacy on cardiovascular risk factors, suggesting the need for a larger volume of PA in these high-risk subjects.
Trial Registration isrctn.org Identifier: ISRCTN04252749
Editor's Comment: Two studies on Type 2 diabetes mellitus (T2D) have been selected this month. These studies are good representations of most of the literature on the effects of exercise on T2D. Generally, it is well-accepted that exercise and physical activity are not only beneficial in the treatment of T2D but are in fact cornerstones of efficacious treatment. This is not news, but these two studies establish some findings that may be of interest and use to cardiac rehabilitation professionals, and I suggest that both are worth reading.
Church et al used a design that they have previously published with respect to randomizing and quantifying the amount of exercise in intervention groups. They randomized participants (N = 262) into control, aerobic (AT), resistance (RT), and combined aerobic-resistance (CT) training groups. They matched exercise between groups at 12 kcal/kg/week (10 kcal/kg/week in the RT group). Church et al reported actual exercise levels across all intervention groups were a mean of 140 minutes per week. They report a 70% adherence level. Results demonstrated that HbA1c was reduced significantly only in the CT group. The results are important because during the study, all groups received ongoing medical care that included medication adjustments. The control group increased use of diabetic medications, whereas the CT group decreased use. Thus, despite therapeutic efforts in the control group to control blood glucose (and therefore HbA1c), the level of improvement in the CT group was significantly better than in the control group. Exercising groups reduced waist circumference, RT and CT groups also lost fat mass, and CT was the only group to lose weight.
The Italian Diabetes and Exercise Study used a larger group of participants (N = 606) randomized to an exercise-counseling group and a counseling-alone (control) group. The exercise group was supervised twice per week. Training consisted of 150 minutes per week of cardiovascular endurance training supplemented with 4 basic resistance training exercises. They report an 80% adherence rate. This study reports significant decreases in HbA1c and waist circumference in the exercise group. It is interesting to note that the reduction in HbA1c was similar to that in Church et al's study. Additionally, the exercise group demonstrated significant improvements in insulin resistance, systolic blood pressure, diastolic blood pressure, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, body mass index, and high sensitivity c-reactive protein level. The control group improved fasting blood glucose, waist circumference, blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels. It is important to note that adjustments in medication were ongoing throughout this study. Despite active medical therapy and an accompanying significant decrease in fasting blood glucose, there was no accompanying decrease in HbA1c in the control group. Furthermore, both metformin and insulin use increased in the control group, whereas their use decreased in the exercise group. This article has an accompanying editorial that is interesting and also worth reading. -JLR