A randomized trial investigating an exercise program to prevent reduction of bone mineral density and impairment of motor performance during treatment for childhood acute lymphoblastic leukemia. Controlled trial of calcitriol in hemodialysis patients. Long-term comparative trial of conventional postural drainage and percussion versus positive expiratory pressure physiotherapy in the treatment of cystic fibrosis. [Physical therapy in patients with COPD and tracheobronchial instability--comparison of 2 oscillating PEP systems (RC-Cornet, VRP1 Desitin). Results of a randommized prospective study of 90 patients]. Treatment of idiopathic pulmonary fibrosis with etanercept: an exploratory, placebo-controlled trial. Extracorporeal shock wave therapy for lateral epicondylitis--a double blind randomised controlled trial. A nurse-led cardiac rehabilitation programme improves health behaviours and cardiac physiological risk parameters: evidence from Chengdu, China. [Course of Severe COPD with and without Physiotherapy with the RC-Cornet(R)]. Effect of short term intensive multitherapy on carotid intima-media thickness in patients with newly diagnosed type 2 diabetes mellitus.
Reduced bone mineral density (BMD), altered body composition, impaired motor performance and passive ankle dorsiflexion are side effects of acute lymphoblastic leukemia (ALL) treatment. We performed a randomized study investigating whether an exercise program could prevent these side effects.
                At diagnosis we randomized 51 ALL patients (median age: 5.4 years) into a group receiving a 2-year exercise program or a control group receiving standard care. BMD of total body (BMD(TB)), lumbar spine (BMD(LS)) and body composition were measured using dual energy X-ray absorptiometry, motor performance with Bayley Scales of Infant Development or Movement-ABC, and passive ankle dorsiflexion with a goniometer. The investigator was blinded to the randomization.
                Body fat increased equally during treatment in both groups. One year after cessation of therapy more rapid decline of excessive body fat was observed in the intervention group than in the controls (P = 0.01). Lean body mass, BMD(TB) and BMD(LS) of both groups decreased equally during treatment and increased equally thereafter. Both groups showed a similar decrease in passive ankle dorsiflexion and motor performance during treatment. Adherence to the intervention program varied considerably. Adherence to intervention: 11% of children exercised daily, 37% > once a week, 16% once weekly, 36% < once a week.
                The exercise program was not more beneficial than standard care in preventing reduction in BMD, motor performance and passive ankle dorsiflexion than standard care, most likely due to unsatisfactory compliance. Increased BMI and body fat in the intervention group normalized faster after cessation of chemotherapy.
                Copyright 2009 Wiley-Liss, Inc. We report on a 5-year, prospective, double-blind trial of 1,25 dihydroxycholecalciferol (calcitriol) versus placebo in 76 hemodialysis patients without biochemical or radiological evidence of bone disease. Calcitriol, 1 microgram daily, regularly induced hypercalcemia. Doses of 0.25 microgram daily or less proved satisfactory in most patients. During calcitriol treatment, plasma calcium concentration was significantly higher and serum parathyroid hormone concentration significantly lower than on placebo. There was no difference in the rates of development or of progression of vascular calcification in the two groups. Significantly more patients on placebo (17 vs. 6, p less than 0.05) developed a sustained elevation of plasma alkaline phosphatase concentration. Calcitriol appeared to protect against the development of histological evidence of osteitis fibrosa but not of osteomalacia, but accumulation of aluminum in bone occurred during the study. We conclude that calcitriol delays and may prevent the development of osteitis fibrosa in patients receiving regular hemodialysis and may reasonably be prescribed routinely in hemodialysis patients without biochemical or radiological abnormality, unless there is a substantial prospect of early renal transplantation. We report the results of a long-term comparative trial of physiotherapy by the positive expiratory pressure (PEP) technique with a PEP mask (Astra Meditec) versus conventional postural drainage and percussion (PD&P). Forty patients, ages 6 to 17 years, with Shwachman scores between 52 and 93, attending the cystic fibrosis clinic were enrolled in the study and randomly assigned to one of two groups. Group A (control) continued to perform physiotherapy by using PD&P for a 1-year period, whereas patients assigned to group B performed physiotherapy with the PEP technique for the same period. Compliance with physiotherapy was closely monitored for both groups throughout the study. Clinical status and pulmonary function (forced vital capacity [FVC], FEV1, and FEF25-75) were measured at 3-month intervals. Group B (PEP) demonstrated improved pulmonary function in all parameters as measured by change in percent predicted value for age, gender, and height. The changes in pulmonary function over the study period were: FVC, +6.57; FEV1, +5.98; and FEF25-75, +3.32. This improvement was significantly different from that of group A (PD&P) whose pulmonary function declined in all parameters (FVC, -2.17; FEV1, -2.28; FEF25-75, -0.24). The differences between treatment groups were statistically significant for the changes in FVC (p = 0.02) and FEV(1) (p = 0.04). Our results indicate that for our patients with cystic fibrosis, pulmonary physiotherapy with the PEP technique was superior to conventional physiotherapy with the PD&P technique. In a randomized prospective study in 90 patients with COAD and tracheo-bronchial instability 3 groups were formed. Group 1: Therapy as group 3+ Physiotherapy with VRP1 Desitin, Group 2: Therapy as group 3+ Physiotherapy with RC-Cornet, Group 3: Control group: daily 40 mg prednisolon i.v., 2 x theophylline i.v. in relation to serum levels and 3 x inhalation of beta 2+ parasympathicolytic with a compressor inhaler. Therapy group 1 and 2 received the same drug and inhalation therapy as the controls. Controls of lung function before and after physiotherapy and visual analog scales for dyspnoea, cough, sputum and acceptance of the physiotherapy were performed at days 1, 4 and 7. With RC-Cornet the residual volume decreases statistically significant in comparison to VRP1 Desitin. Hyperventilation is also statistically significant smaller in RC-Cornet compared to VRP1 Desitin. The subjective improvement of sputum, dyspnoea and acceptance of the method of physiotherapy was statistically significant better for RC-Cornet. Regarding cough the significance was just failed by p < 0.055. RC-Cornet is a comfortable, effective, small accepted tool for the long term physiotherapy of patients with COAD and tracheobronchial instability. An efficacious medical therapy for idiopathic pulmonary fibrosis (IPF) remains elusive.
                To explore the efficacy and safety of etanercept in the treatment of IPF.
                This was a randomized, prospective, double-blind, placebo-controlled, multicenter exploratory trial in subjects with clinically progressive IPF. Primary endpoints included changes in the percentage of predicted FVC and lung diffusing capacity for carbon monoxide corrected for hemoglobin (Dl(CO(Hb))) and change in the alveolar to arterial oxygen pressure difference P(a-a)(O(2)) at rest from baseline over 48 weeks.
                Eighty-eight subjects received subcutaneous etanercept (25 mg) or placebo twice weekly as their sole treatment for IPF. No differences in baseline demographics and disease status were detected between treatment groups; the mean time from first diagnosis was 13.6 months and mean FVC was 63.9% of predicted. At 48 weeks, no significant differences in efficacy endpoints were observed between the groups. A nonsignificant reduction in disease progression was seen in several physiologic, functional, and quality-of-life endpoints among subjects receiving etanercept. There was no difference in adverse events between treatment groups.
                In this exploratory study in patients with clinically progressive IPF, etanercept was well tolerated. Although there were no differences in the predefined endpoints, a decreased rate of disease progression was observed on several measures. Further evaluation of TNF antagonists in the treatment of IPF may be warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 00063869). Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach to the treatment of a number of soft tissue complaints. Whilst benefit has been demonstrated in calcific tendinitis, evidence is lacking for benefit in the management of non-calcific rotator cuff disorders.
                To perform a double-blind placebo controlled trial of moderate dose ESWT in chronic lateral epicondylitis.
                Adults with lateral epicondylitis were randomised to receive either active treatment (1500 pulses ESWT at 0.12 mJ/ mm2) or sham therapy, monthly for three months. All were assessed before each treatment and one month after completion of therapy. Outcome measures consisted of visual analogue scores for pain in the day and at night.
                Seventy-five subjects participated and there were no significant differences between the two groups at baseline. The mean duration of symptoms was 15.9 and 12 months in the ESWT and sham groups, respectively. Both groups showed significant improvements from two months. No significant difference existed between the groups with respect to the degrees of change in pain scores over the study period. In the ESWT group the mean (SD, range) pain score was 73.4 (14.5, 38-99) at baseline and 47.9 (31.4, 3-100) at three months. In the sham group the mean (SD, range) pain score was 67.2 (21.7, 12-100) at baseline and 51.5 (32.5, 3-100) at three months. At three months, 50% improvement from baseline was noted in 35% of the ESWT group and 34% of the sham group with respect to pain.
                There appears to be a significant placebo effect of moderate dose ESWT in subjects with lateral epicondylitis but there is no evidence of added benefit of treatment when compared to sham therapy. The aim of this study was to examine the effect of a cardiac rehabilitation programme on health behaviours and physiological risk parameters in patients with coronary heart disease in Chengdu, China.
                Epidemiological studies indicate a dose-, level- and duration-dependent relationship exists between cardiac behavioural and physiological risks and coronary heart disease incidence as well as subsequent cardiac morbidity and mortality. Cardiac risk factor modification has become the very primary goal of modern cardiac rehabilitation programmes.
                A randomized controlled trial was conducted. Coronary heart disease patients (n = 167) who met the sampling criteria in two tertiary medical centres in Chengdu, south-west China, were randomly assigned to either an intervention group (the cardiac rehabilitation programme) or control group (the routine care). The change of health behaviours (walking performance, step II diet adherence, medication adherence, smoking cessation) and physiological risk parameters (serum lipids, blood pressure, body weight) were assessed to evaluate the programme effect.
                Patients in the intervention group demonstrated a significantly better performance in walking, step II diet adherence, medication adherence; a significantly greater reduction in serum lipids including triglyceride, total cholesterol, low-density lipoprotein; and significantly better control of systolic and diastolic blood pressure at three months. The majority of these positive impacts were maintained at six months. The effect of the programme on smoking cessation, body weight, serum high-density lipoprotein, was not confirmed.
                A cardiac rehabilitation programme led by a nurse can significantly improve the health behaviours and cardiac physiological risk parameters in coronary heart disease patients. Nurses can fill significant treatment gaps in the risk factor management of patients with coronary heart disease.
                This study raises attention regarding the important roles nurses can play in cardiac rehabilitation and the unique way for nurses to meet the rehabilitative care needs of coronary heart disease patients. Furthermore, the hospital-home bridging nature of the programme also created a model for interfacing the acute care and community rehabilitative care. The efficacy of respiratory physiotherapy by combined-PEP (RC-Cornet(R) in combined-PEP-position) was evaluated in a long-term study with the following set up.
                Randomized prospective clinical trial over 2 years in 50 patients with severe COPD (12 f, 38 m, 63,1 y, FEV 1 41 %, DLCO 51 % of the normal). Patients were without infection and exsmokers at begin of the trial. One group was treated only by drug therapy (theophylline, salmeterol, ipratropiumbromide, systemic steroids 5 mg prednisolone equivalent). The second group received the same drug therapy plus physical therapy with the RC-Cornet(R) (oscillating PEP; in combined PEP-position) 3 times daily at least for 5 minutes or whenever needed. Lung function data were controlled every 3 month during first year and every 4 month in the second year. The compliance was checked by theophylline and cortisol blood levels, inspection of the functionality of the RC-Cornet(R) and by questioning the patient about compliance with the therapy.
                TGV (% of normal) and airway resistance (measured by bodyplethysmography) decreased significantly in contrast to the "mere" drug therapy (p < 0.0177, p < 0.0179). VC (% of normal) increased significant p < 0.0179 in the RC-Cornet(R) therapy group. In this group significantly less patients (13/24) needed antibiotics in comparison to the "mere" drug group (Chi-Quadrat p < 0.0004). Also the need for hospital care was significantly less in the RC-Cornet(R) group (5/12) in comparison to the drug therapy group (Chi-Quadrat < 0.000765). The length of hospital stay in the two groups was not significantly different: 16.2 +/- 6.3 days in the RC-Cornet(R)-group and 18.3 +/- 4.7 days in the drug therapy-group.
                This study proves the efficacy of respiratory physiotherapy with combined-PEP in addition to drug therapy in the management of COPD-patients. Controlling plasma glucose levels, blood pressure and lipid levels is proven to reduce the risk of vascular complications in patients with type 2 diabetes mellitus. This has prompted intensive multitherapy targeted at several macrovascular risk factors. Carotid intima-media thickness (cIMT) is a reliable measure of early atherosclerosis. We sought to determine whether a 6-month intensive mutiltherapy program resulted in better goal attainment than usual care and its effect on the development of cIMT among patients with newly diagnosed type 2 diabetes mellitus.
                The study randomly assigned 220 patients with newly diagnosed type 2 diabetes mellitus to intensive or traditional therapy groups. The clinical parameters, such as fasting plasma glucose, total cholesterol, triglyceride, blood pressure, body weight and insulin were assessed at the baseline and after the 6-month therapy. cIMT of the patients was also obtained.
                The average levels of fasting plasma glucose, hemoglobin A1c, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the intensive group were significantly lower than those in the control group at the end of 6-month treatment. By 6 months, a higher proportion of patients in the intensive therapy group than in the control group attained goals for fasting plasma glucose (FPG), TC, LDL-C and hemoglobin A1c. With intensive multherapy the level of carotid intima-media thickness in the intensive therapy group was lower than that in the control group ((0.88 +/- 0.26) mm vs (0.96 +/- 0.22) mm, P < 0.01).
                The evidence from this clinical trial demonstrates that intensive glucose, lipid and blood pressure control in patients with newly diagnosed type 2 diabetes is associated with diabetic macrovascular benefits. Intensive multitherapy allows more patients to achieve aims of control and may reduce macrovascular complications and delay disease progression.
Calcimimetic treatment of SHPT leads to significant improvements in biochemical parameters that observational studies have shown to be associated with increased mortality, cardiovascular risk and osteitis fibrosa, but patient-based benefits have not yet been demonstrated in trials. For patients with SHPT, the benefits of calcimimetics over standard therapy remain uncertain until further RCTs become available.