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PubMedDate not supplied

Comparison of nasal cannulas and the OxyArm in patients requiring chronic domiciliary oxygen therapy.

OBJECTIVES: The present study was designed to compare the performance of a new oxygen delivery device, the OxyArm (OA) (Southmedic Inc, Canada), with a standard nasal cannula (NC) (Salter-Style 1600, Salter Labs, USA) for both oxygen delivery and patient preference in patients on long-term oxygen therapy (LTOT). DESIGN AND SETTING: Randomized crossover study conducted in an outpatient setting. PATIENTS AND METHODS: Twenty-five clinically stable LTOT patients were randomly assigned to an oxygen device (NC or OA) sequence. The baseline saturation level was determined, and patients were then treated at oxygen flow rates of 2 L/min, 3 L/min, 4 L/min, 5 L/min, 6 L/min and 7 L/min for 10 min each while at rest. Patients were then crossed over to the second device and the procedure was repeated. Oximetry values were then obtained following a 5 min walk test using the same device sequence. Lastly, the patients were sent home for a four-week home OA trial, after which, they filled out a questionnaire. RESULTS: This sample of patients was primarily elderly ex-smokers with severe chronic obstructive pulmonary disease on oxygen therapy for the majority of the day. The primary findings were that the OA and NC were equally effective in delivering oxygen to patients and maintaining their oxygen saturation at both rest (P = 0.82) and during a 5 min walk test (P = 0.83). A patient's personal experience and comfort were identified as the most important factors in deciding on an oxygen device. Most patients felt that the OA was most suited for oxygen therapy while at rest. CONCLUSIONS: The OA proved to be similar to the NC in delivering oxygen and maintaining saturation in patients on LTOT. The OA is one of the few alternatives to using NCs for these patients and, with its current design, appears to be most suited for resting conditions.

Aged↗

PubMed2002

Effects of formoterol and ipratropium bromide in COPD: a 3-month placebo-controlled study.

The aim of this study was to compare the effects of formoterol, ipratropium bromide and a placebo on walking distance, lung function, symptoms and quality of life (QoL) in chronic obstructive pulmonary disease (COPD) patients. A total of 183 patients (mean age 64 yrs, 86 female) with moderate-to-severe nonreversible COPD participated in this randomised, double-blind, parallel-group study. After a 2-week placebo run-in, patients were randomised to formoterol Turbuhaler 18 microg b.i.d. (delivered dose), ipratropium bromide 80 microg t.i.d. via a pressurised metered dose inhaler, or placebo for 12 weeks. Inhaled short-acting beta2-agonists were allowed as relief medication and inhaled glucocorticosteroids were allowed at a constant dose. The primary variable was walking distance in the shuttle walking test (SWT). Baseline mean SWT distance was 325 m, mean forced expiratory volume in one second (FEV1) was 40% predicted. Clinically significant improvements in SWT (>30 m) were seen in 41, 38 and 30% of formoterol, ipratropium and placebo patients, respectively (not significant). Mean increases from run-in were 19, 17 and 5 m in the formoterol, ipratropium and placebo groups, respectively. Both active treatments significantly improved FEV1, forced vital capacity, peak expiratory flow and daytime dyspnoea score compared with placebo. Formoterol reduced relief medication use compared with placebo. Neither active treatment improved QoL. Formoterol and ipratropium improved airway function and symptoms, without significant improvements in the shuttle walking test.

Adrenergic beta-Agonists↗

PubMed2001

Severe pulmonary hypertension: data from the Swiss Registry.

BACKGROUND: Severe pulmonary hypertension (PH) is a rare disease with a dismal prognosis if untreated. Progress in diagnosis and in the development of effective therapeutic options has created new interest in this pathology. There are, however, only limited data on the prevalence of severe PH unrelated to chronic left ventricular failure or COPD, on the associated conditions and on the parameters with a prognostic impact. With the aid of a retrospective registry we have collected data from 5 centres in Switzerland and attempted to answer the above questions. METHODS: Data on patients with PH from 4 university facilities (Zurich, Basle, Geneva and Lausanne) and one well-defined geographical area (Ticino) were retrospectively collected and analysed up to December 1999. Clinical and haemodynamic parameters and associated diseases were noted. We were also interested in the age distribution of the patients and the year of diagnosis of PH. RESULTS: We found 106 patients with severe PH (43 men, 63 women, median age 43 years); 79% were in NYHA class III or IV. There was a steep rise in diagnosis of PH after 1995. In 74% PH was either primary or associated with collagen vascular disease or thromboembolic disease. By the end of the observation period 30% of the patients had died. The best distinguishing parameters between surviving patients and those who eventually died were the 6-minute walking test (363 vs. 235 metres, p = 0.002), the NYHA class (II vs III/IV, p = 0.015), and mixed venous saturation (66.5 vs. 57.9%, p = 0.006). Therapy consisted of calcium antagonists in 18% and of (inhaled) prostanoids, chiefly iloprost, in 33%. Seven patients underwent lung transplantation. CONCLUSIONS: We conclude that PH is diagnosed more often as diagnostic and therapeutic options improve; that primary forms, and those associated with collagen vascular disease and with chronic venous thromboembolism, make up three-quarters of the aetiologies; and that the 6-minute walking test, the functional class and mixed venous saturation are the best prognostic parameters.

Adolescent↗

PubMed1995

Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery.

OBJECTIVE: To determine the safety and effectiveness of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. METHODS: High risk patients were defined as those presenting with severe left ventricular dysfunction with an ejection fraction less than 35%, severe ventricular arrhythmias, incomplete revascularization, abnormal response to a standard walking test or significant (grade 3/4) valvular regurgitation persisting postoperatively. Eighty patients (mean age 58.5 +/- 8.9 years) were randomly assigned to two groups. The experimental group (n = 37) received a home program of aerobic training with an intensity gradually increasing from 1.5 to 4.0 multiples of resting oxygen consumption (METs). This program was started at discharge from the hospital and lasted eight weeks. The control group (n = 43) received general guidelines for progressive increase of their activity level. Functional capacity was measured at discharge by the 6 min walking test and between the sixth and eighth week following discharge by a symptom-limited exercise test, according to the Naughton protocol. RESULTS: No cardiovascular complications occurred during the training program. At the final evaluation, there was no significant difference between the experimental and control groups regarding aerobic capacity (5.1 +/- 1.8 versus 4.9 +/- 1.6 METs respectively, P = 0.61), nor peak rate-pressure product (22.8 +/- 4.9 versus 23.6 +/- 5.2 beats/min x mmHg x 10(3) respectively, P = 0.54).

Aged↗

PubMed1990

Objectifying exercise ischemia in peripheral vascular disease: a study in 120 patients.

This study presents the results of transcutaneous oxygen pressure (TcPO2) monitoring during a treadmill test walk performed in the early stages of peripheral obliterative vascular disease. The study population consisted of a first group of 50 known arteriopathic patients presenting, on questioning, with intermittent claudication; a second group of 50 known arteriopathic patients void of any symptoms of intermittent claudication; and a third group, which was a control cohort of 20 nonarteriopathic, nonclaudicating patients. Though resting TcPO2 cannot be used to aid the clinical diagnosis of exercise ischemia it may be useful in revealing asymptomatic chronic resting ischemia (9% of cases in this series). On the other hand, a posteffort (recovery phase) fall in TcPO2 had a predictive positive diagnostic accuracy for ischemia on exercise in 99% of the cases reported here versus 87% for clinical appraisal. In the light of these results, TcPO2 measurements coupled to a treadmill test walk perfectly ascertain exercise ischemia in arteriopathic patients, whether asymptomatic or not, and avoid the false-positive results obtained by clinical evaluation.

Aged↗

PubMed2004

The effects of strength training on gait in adolescents with cerebral palsy.

PURPOSE: This study was designed to examine the effects of strength training on gait velocity, cadence, step length, and energy expenditure as well as the distance ambulated during a three-minute walk test in adolescents with cerebral palsy (CP) and to provide an assessment of subjects' preference for exercising in a community fitness setting. METHODS: Seven adolescents with CP participated in a six-week strengthening program. Two subjects performed the program at a local fitness center, and five participated at a local high school gym. Subjects, aged 12 to 20 years, were evaluated before and after intervention for trunk and lower extremity muscle strength, gait velocity, cadence, step length, energy expenditure, and the distance ambulated during a three-minute walk test. Data were analyzed using the nonparametric, Wilcoxon signed-rank test. RESULTS: All five dependent variables were found to change significantly after the intervention period. CONCLUSION: Strength training is an important aspect of physical therapy intervention in general, and this study suggests that it is also an effective intervention for the population of adolescents with CP. In addition, all subjects provided subjective feedback supporting their preference for completing the strengthening program in a fitness center or school gym as opposed to exercising during a typical physical therapy session.

Journal Article↗

PubMed2005

The role of levodopa in the management of dementia with Lewy bodies.

BACKGROUND: One of the core clinical features of dementia with Lewy bodies (DLB) is extrapyramidal syndrome (EPS). Levodopa is currently the gold standard oral therapy for Parkinson's disease (PD), but its use in DLB has been tempered by concerns of exacerbating neuropsychiatric symptoms. AIM: To assess the efficacy and tolerability of L-dopa in managing EPS in DLB and to compare the motor response with that seen in PD and PD with dementia (PDD). METHOD: EPS assessment consisted of the Unified Parkinson's Disease Rating Scale, motor subsection (UPDRS III), and finger tapping and walking tests. Patients with DLB were commenced on L-dopa. After 6 months, patients were examined in the "off" state, given L-dopa and assessed for motor responses. Identical assessments were performed in patients with PD and PDD also receiving L-dopa. RESULTS: Acute L-dopa challenge in 14 DLB patients yielded a mean 13.8% (p = 0.02) improvement in UPDRS III score, compared with 20.5% in PD (n = 28, p < 0.0001) and 23% in PDD (n = 30, p<0.0001) respectively. Finger tapping scores increased (12.3% v 20% and 23%), while walking test scores decreased (32% v 41% and 67%). Of the DLB patients, 36% were classified as "responders" on L-dopa challenge, compared with 70% of the PDD and 57% of the PD patients. Nineteen DLB patients were treated for 6 months with L-dopa (mean daily dose 323 mg). Two withdrew prematurely with gastrointestinal symptoms and two with worsening confusion. CONCLUSION: L-dopa was generally well tolerated in DLB but produced a significant motor response in only about one third of patients. Younger DLB cases were more likely to respond to dopaminergic treatment.

Administration, Oral↗

PubMed1993

Assessment of quality of life as observed from the baseline data of the Studies of Left Ventricular Dysfunction (SOLVD) trial quality-of-life substudy.

The improvement of aspects of a patient's quality of life may be as important as prolonging survival in evaluating clinical trials of heart failure. The purpose of this study was to analyze the psychometric properties of the baseline measures from the quality-of-life substudy from the Studies of Left Ventricular Dysfunction (SOLVD) trial. The measures included the 6-Minute Walk Test, Dyspnea Scale, Living with Heart Failure, Physical Limitations, Psychologic Distress and Health Perceptions, as reported by both patients and staff. Cognitive functioning, such as Vocabulary, Digit Span and Trails Making, was also assessed. Patients were classified as New York Heart Association class I (n = 158) versus II or III (n = 150). The internal consistencies (i.e., reliabilities) of the self-report measures were high, except for the Health Perceptions of Class II or III patients. Reliability of the SOLVD quality-of-life battery was confirmed by significantly better life quality among New York Heart Association class I patients versus class II or III patients combined on the Walk Test, Physical Limitations, Dyspnea, Living with Heart Failure, Psychologic Distress and staff perceptions of patient health. In accordance with prior studies, the measures were uncorrelated with left ventricular ejection fraction. By demonstrating strong internal consistencies, reliability based on physician reports, and independence of ejection fraction levels, use of this quality-of-life assessment battery in this and other clinical trials of compromised ventricular functioning is supported.

Attitude to Health↗

PubMed2003

Relief of drug refractory angina by biventricular pacing in heart failure.

Since cardiac resynchronization therapy (CRT) improves LV function at the cost of low energetic expenditure, the authors hypothesized that it may increase the threshold of drug refractory angina in selected patients with CHF and CAD who are not amenable to myocardial revascularization. From October 1999 to April 2002, 75 patients with CHF and CAD were treated with CRT. Drug refractory angina occurred nearly daily in 8 of the 75 patients. The mean age of these eight men was 71 years, mean NYHA functional Class 3.4 +/- 0.5, mean QRS duration (QRSd) 168 +/- 20 ms, and mean left ventricular ejection fraction (LVEF) 0.29 +/- 0.4. Diffuse CAD not amenable to myocardial revascularization was confirmed on angiography. At baseline, no patient was able to complete a 6-minute walk test because of angina. In the 6 months before CRT, the mean number of hospitalizations per patient for management of CHF or angina was 3.1 +/- 0.3. All patients underwent successful CRT. Mean QRSd decreased to 141 +/- 16 ms (P = 0.01 vs baseline). After 9 +/- 6.1 months, LVEF increased to 0.317 +/- 0.028 (P = 0.03 vs baseline), while the NYHA class decreased to 2.6 +/- 0.5 (P = 0.02 vs baseline). All patients also experienced a marked decrease in angina episodes, from a mean of 8.3 +/- 11.6 to 0.6 +/- 1.3 episodes/week (P < 0.05), and completed a 6-minute walk test, covering a mean distance of 337 +/- 68 m (vs 237 +/- 136 m at baseline, P = 0.007). No further hospitalization was necessary. The beneficial effects of CRT on overall cardiac function may include a better control of angina in severely symptomatic patients.

Aged↗

PubMed1996

Effect of nebulized fenoterol on spirometry, dyspnea sensation changes during exercise in patients with chronic obstructive pulmonary disease.

Airflow limitation impairs exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Bronchodilators have been shown to increase exercise tolerance in patients with COPD by mechanisms yet unclarified. We studied the effect of nebulized fenoterol (0.5 mg/ml) on the 6-minute walking test (WT) 60 mins after a control WT using a nebulized saline control in 16 patients with moderate to severe COPD. Before and immediately after each WT, the FEV1, FVC, O2, Saturation and dyspnea score (Borg breathlessness score,[BS]) were measured. Fenoterol had no significant effect on pre-exercise spirometry in our patients but maintained a significantly higher level of FEV1 (0.9 +/- 0.1L, p < 0.0001) and FVC (2.0 +/- 0.2L, p < 0.01) immediately after exercise than that after saline control nebulization (0.7 +/- 0.1L, 1.8 +/- 0.2L, respectively). Fenoterol significantly (p < 0.01) increased walking distance (WD) from 201.3 +/- 22.2m to 238.9 +/- 22.2m, but no difference was found in BS and oxygen saturation. The decline in FEV1 following the WT was shown to have an inverse relationship (r = - 0.74, p < 0.002) with the WD improvement (delta WD). Those who walked farther after fenoterol inhalation felt less dyspnea after exercise, also with an inverse correlation (r = -0.61, p < 0.02). These results suggest that fenoterol may improve exercise capacity by preventing airflow deterioration during exercise in patients with COPD. We also recommend the 6-minute walking test in the routine clinical assessment of COPD patients to evaluate the symptomatic benefit offered by betamimetic bronchodilators.

Adrenergic beta-Agonists↗

PubMed2004

[Lung function and exercise tolerance after treatment with salmeterol or ipratropium bromide in chronic obstructive pulmonary disease].

The aim of this study was to compare the effects of 6 months therapy with salmeterol or ipratropium bromide on lung function (resting and dynamic parameters), exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). In open, randomised study patients at visit 1 were included into trial, at visit 2 and, after 6 months therapy, at visit 3 lung function measured by a pressure body plethysmography, exercise tolerance was investigated by 6 minute walking test and dyspnoea was analysed by the means of Borg scale. We studied 24 patients (18 males, 6 females, range age 45-76 yrs, mean: 60.2+/-10.46) with stable COPD. 13 subjects (mean FEV1 = 63.61% predicted, SD = 15.66%) received salmeterol (2 x 50 microg/day) and 11 subjects (mean FEV1 = 62.52% predicted, SD = 12.39%) received ipratropium bromide (4 x 40 microg/day). There were no significant changes in lung function parameters (FEV1, VC, Rtot, TLC, RV and RV%TLC) after 6 months therapy with both drugs, but the treatment with salmeterol significantly improves exercise tolerance in 6 minute walking test (p=0.048) and Borg dyspnea ratings (p=0.008).

Aged↗

PubMed1987

Grading of dyspnoea and walking speed in cardiac disease and in chronic airflow obstruction.

A five-point dyspnoea scale (modified MRC questionnaire) and 12-minute walking test were used to compare the relationship between subjective assessment of dyspnoea and objective measurement of disability in patients with chronic airflow limitation, cardiac disease, and normal subjects. There was no overall difference in exercise performance between the cardiac and respiratory groups. There was a significant correlation between vital capacity and exercise performance, and the slope of the regression line was similar in the two groups. There was no correlation between vital capacity and exercise performance in the group of normal subjects. The five-point dyspnoea scale predicts similar levels of performance in the 12-minute walking test whether the dyspnoea is a result of cardiac or respiratory disease.

Adult↗

PubMedDate not supplied

Radionuclide monitoring of left ventricular function after sublingual nifedipine administration at rest and during moderate physical activity.

BACKGROUND: This study investigates the acute effects of nifedipine administration on left ventricular (LV) function in patients with different degrees of heart failure at a fixed heart rate under resting conditions and during moderate physical activity. METHODS AND RESULTS: Eleven patients with non-rate-responsive DDD pacemakers were studied. According to baseline LV ejection fraction, patients were divided into 2 groups: 6 patients with an ejection fraction of less than 50% (group 1) and 5 patients with an ejection fraction of 50% or more (group 2). LV function was monitored by a radionuclide system (Vest) at rest and during moderate physical activity (10-minute walk test) before and after sublingual nifedipine administration (10 mg). In all patients, both the systolic blood pressure and diastolic blood pressure were significantly reduced (P <.05) 6 minutes after nifedipine administration. In group 1, end-diastolic volume and ejection fraction decreased after 3 minutes and remained significantly lower (P <.05) than resting values until 10 minutes after drug administration, whereas end-systolic volume was unchanged. In group 2, nifedipine induced a minor decrease in end-diastolic volume and a slight but not significant decrease in ejection fraction and end-systolic volume. During the walk test, nifedipine induced similar changes in all parameters of cardiac performance in both groups. CONCLUSIONS: In patients with impaired LV function, acute nifedipine administration has a negative effect on cardiac performance, which occurs before blood pressure reduction. On the other hand, during moderate physical activity, nifedipine does not affect the improvement in LV function.

Administration, Sublingual↗

PubMed2002

[Lung volume reduction surgery for emphysema. Long term results].

We prospectively analyzed 19 patients submitted to lung volume reduction surgery (LVRS). Mean age 54 years. Fourteen patients, with predominant emphysema of upper lobes, were approached through a median sternotomy. Five patients with predominant lower lobes lesions, were approached through a bilateral anterolateral thoracotomy. Surgery consisted in resection of 20 to 30% of lung volume corresponding to areas of severe parenchymal destruction by stapling suture additioned with bovine pericardium. Changes in lung function and physical performance were evaluated by FEV1, FVC and RV, 6 minutes walk test and dyspnea index according to Medical Research Council at 3, 12, 24, 36 and 48 months. Variance analysis with correction of Bonferroni was performed. One patient died of acute myocardial infarction. There was a significant average improvement in all parameters measured at 3, 12, 24 and 36 months with regard to preoperative values. Comparing the preoperative and 3 months values, there was an increment in FEV1 from 0.94 +/- 0.37 (31% of predicted) to 1.35 +/- 0.40 L (45%) (p < 0.05), in FVC from 2.24 +/- 0.69 (54%) to 3.05 +/- 0.80 L (75%) (p < 0.05) and in 6 minutes walk test from 395 +/- 66 to 517 +/- 50 mts (p < 0.001). There was also a decrease in the RV of 4.78 +/- 1.14 L (284%) to 3 +/- 0.68 L (180%) (p < 0.001) and in dyspnea index of 3.34 +/- 0.82 to 0.53 +/- 0.53 (p < 0.001). The percentage of average increment in FEV1 was 53% at 3 months (n = 18), 72% at 12 months (n = 13), 58% at 24 months (n = 10), 53% at 36 months (n = 6) and 60% at 48 months (n = 3). LVRS can be performed with acceptable morbidity and mortality in highly selected emphysematous patients. Decrease of dyspnea and improvement in physical performance reach a maximum between 3 and 12 months and may remain so after four years.

Adult↗

PubMed2000

Bilateral versus single lung transplantation for chronic obstructive pulmonary disease: intermediate-term results.

BACKGROUND: There is controversy regarding the transplant procedure of choice in chronic obstructive pulmonary disease. We reviewed our intermediate-term outcomes with single lung transplantation (SLT) versus bilateral lung transplantation (BLT). METHODS: We retrospectively reviewed 130 patients with chronic obstructive pulmonary disease: 84 underwent SLT, 46 BLT. The mean age was 51.1 +/- 1.2 years for those who underwent BLT and 56.2 +/- 0.7 years for those who underwent SLT (p < 0.0001). Male patients represented 65% of the BLT group and 46% of the SLT group (p = 0.04). Spirometry and 6-minute walk tests were obtained preoperatively and at 3- to 6-month intervals. Posttransplant survival and survival from time of onset of bronchiolitis obliterans syndrome were calculated by Kaplan-Meier method. The mean follow-up was 32.4 months. RESULTS: The 90-day mortality rate was 13.0% For BLT and 15.5% for SLT (p = 0.71). Actuarial survival rates at 1, 3, and 5 years were 82.6%, 74.6%, and 61.9% for BLT and 72.2%, 63.4%, and 57.4% for SLT; the favorable survival trend with BLT did not achieve statistical significance. There were no differences in preoperative spirometry or 6-minute walk tests. The improvements in forced expiratory volume in one second, forced vital capacity (FVC), and 6 MWT were significantly greater following BLT. The incidence of bronchiolitis obliterans syndrome was 22.4% in SLT and 22.2% in BLT; survival following onset of bronchiolitis obliterans syndrome was similar. CONCLUSIONS: For patients with chronic obstructive pulmonary disease, BLT is associated with superior lung function, exercise tolerance, and a trend toward enhanced survival. Younger candidates may be best suited for BLT. Given the limited donor lungs, SLT remains the preferred alternative for all other patients.

Bronchiolitis Obliterans↗

PubMed2006

[Clinical, functional and hemodynamic features of patients with pulmonary arterial hypertension].

BACKGROUND: Pulmonary Arterial Hypertension is a rare, progressive and devastating disease with severe consequences in quality of life and survival. AIM: A clinical, functional and hemodynamic assessment of patients with pulmonary arterial hypertension and categorization according to severity. MATERIAL AND METHODS: Prospective registry of patients with arterial pulmonary hypertension, hemodynamically defined. Clinical evaluation was performed using World Health Organization functional score (I to IV) and Borg dyspnea scale. Six minute walking test, echocardiography and right heart catheterization were used for functional and hemodynamic assessment. Intravenous Adenosine was used to assess vascular reactivity during the hemodynamic evaluation. RESULTS: Twenty nine patients were included (25 women, age range 16-72 years). Pulmonary hypertension was idiopathic in 11, associated to connective tissue disease in seven, associated to congenital heart disease in nine and associated to chronic thromboembolism in two. The mean lapse of symptoms before assessment was 2.9 years and 100% had dyspnea (Borg 5.1). Functional class I, II, III and IV was observed in 0, 5, 21 and 3 patients respectively. Six minutes walking test was 378+/-113 m. Mean pulmonary pressure was 59.4+/-12.2 mmHg, cardiac index was 2.57+/-0.88 and pulmonary vascular resistance index: 1798.4+/-855 (dyne.sec)/cm5. Nine patients had a mean pulmonary arterial pressure >55 mmHg and a cardiac index <2.1, considered as bad prognosis criteria. Adenosine test was positive in 17%. CONCLUSIONS: This group of patients with Pulmonary Arterial Hypertension was mainly conformed by young females, with a moderate to severe disease.

Adenosine↗

PubMed1998

Effect of clonidine on heart rate variability in congestive heart failure.

In patients with congestive heart failure, abnormal heart rate variability is a predictor of total mortality and sudden cardiac death. Drugs that improve heart rate variability may have a potential role for improving the survival among these patients. The effects of clonidine were studied in 24 patients with congestive heart failure, sinus rhythm, a left ventricular ejection fraction <0.40, and systolic blood pressure > 115 mm Hg. A 6-minute corridor walk test and 24-hour Holter monitoring were performed before and 42+/-24 days after initiation of clonidine therapy (Catapres-TTS patch, mean dose: 0.33+/-0.21 mg). Changes in other medications used at baseline were not allowed. One patient died suddenly. Two patients did not complete the protocol due to worsening congestive heart failure, which required changes in medications, 1 patient discontinued due to hypotension, and 2 for personal reasons. Among the 18 patients who completed the protocol, the mean RR interval of sinus beats increased from 760+/-106 to 822+/-125 ms (p=0.001) and the distance covered during the 6-minute walk test increased from 1,148+/-277 to 1,255+/-359 feet (p=0.042). Systolic blood pressure decreased from 139+/-15 to 119+/-10 mm Hg (p <0.0001). The following increases were noted in the heart rate variability measurements: high-frequency power in 0.15 to 0.40 Hz: 4.58+/-1.07 to 4.94+/-1.17 In (ms), p=0.002; SD: 47.0+/-16.9 to 52.5+/-18.4 ms, p=0.034; SD of the mean of all RR intervals in 24 hours: 116+/-94 to 130+/-19 ms, p=0.033; SD of all 5-minute mean RR intervals: 106+/-44 to 124+/-66 ms, p=0.042; root-mean square of difference of successive RR intervals: 28.8+/-10.7 to 34.1+/-14.2 ms, p=0.017. Clonidine improves heart rate variability in the patients with congestive heart failure by increasing the parasympathetic tone. It is well tolerated by most patients with heart failure and may have a beneficial effect on exercise capacity.

Adrenergic alpha-Agonists↗

PubMed2005

Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial.

OBJECTIVES: To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain. DESIGN: Multicentre randomised controlled trial. SETTING: 15 secondary care orthopaedic and rehabilitation centres across the United Kingdom. PARTICIPANTS: 349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion. INTERVENTION: Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy. MAIN OUTCOME MEASURE: The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure. RESULTS: 176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was -4.1 (95% confidence interval -8.1 to -0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures. CONCLUSIONS: Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.

Adolescent↗