PAGAT gel dosimetry for everyone: gel production, measurement and evaluation.

Polymer gel (PG) dosimetry is a valuable tool to measure complex dose distributions in 3D with a high spatial resolution. However, due to complex protocols that need to be followed for in-house produced PGs and the high costs of commercially available gels, PG gels are only rarely applied in quality assurance procedures worldwide. In this work, we provide an introduction to perform highly standardized dosimetric PG experiments using PAGAT (PolyAcrylamide Gelatine gel fabricated at ATmospheric conditions) dosimetry gel. PAGAT gel can be produced at atmospheric conditions, at low costs and is evaluated using magnetic resonance imaging (MRI). The conduction of PG experiments is described in great detail including the gel production, treatment planning, irradiation, MRI evaluation and post-processing procedure. Furthermore, a plugin in an open source image processing tool for post-processing is provided free of charge that allows a standardized and reproducible analysis of PG experiments.

A randomized study to evaluate the effect of exercise on fatigue in people with relapsing-remitting multiple sclerosis treated with fingolimod.

BACKGROUND: Fatigue is a major symptom of multiple sclerosis (MS) in patients, and it has been shown to improve with physical exercise. Although fingolimod might lessen fatigue, it is unclear how patients treated with fingolimod react to physical activity regarding fatigue. OBJECTIVE: This study evaluated the effect of an exercise intervention on fatigue in relapsing-remitting MS patients receiving fingolimod. METHODS: People with MS (PwMS) were randomized to either a structured internet-based exercise program (e-training) or no e-training intervention. The primary endpoint was the change in the Modified Fatigue Impact Scale (mFIS) after six months. RESULTS: The primary analysis showed no statistically significant difference between groups in the mFIS change. Subgroup analyses revealed a beneficial effect of physical exercise for PwMS with low aerobic capacity and with low aerobic capacity plus more severe fatigue. The incidence of adverse events was similar in both groups. No cardiovascular events were reported. The majority of PwMS were relapse free. CONCLUSION: Physical exercise benefits on fatigue may depend on the physical capacity of the patient and requires individualized training. Consistent with previous studies, these results suggest that physical exercise generally does not impose a risk and that this holds true also for patients receiving fingolimod.Trial registration: ClinicalTrials.gov, NCT01490840.

Secukinumab is superior to fumaric acid esters in treating patients with moderate-to-severe plaque psoriasis who are naive to systemic treatments: results from the randomized controlled PRIME trial.

BACKGROUND: Secukinumab is a fully human antibody that neutralizes interleukin-17A. It has significant efficacy and a favourable safety profile in moderate-to-severe plaque psoriasis and psoriatic arthritis. OBJECTIVES: To compare secukinumab with fumaric acid esters (FAEs) in a randomized controlled trial. METHODS: In this 24-week, randomized, open-label, multicentre study with blinded assessment, patients with moderate-to-severe plaque psoriasis, naive to systemic treatments, were randomized to receive secukinumab 300 mg subcutaneously or oral FAEs. The primary end point was ≥ 75% improvement from baseline Psoriasis Area and Severity Index score (PASI 75 response) at week 24, and missing patients were considered responders if they were responders at the time of dropout. RESULTS: In total 202 patients were randomized and 200 were treated with at least one dose. Outcomes at week 24 were available for 147 and imputed for 53 patients. Discontinuations were mostly due to adverse events, and occurred more frequently in the FAE group (1·9% vs. 40·0%). At week 24, significantly more patients receiving secukinumab compared with FAEs achieved PASI 75 response (89·5% vs. 33·7%, P < 0·001), PASI 90 response (75·2% vs. 18·9%, P < 0·001) and Dermatology Life Quality Index 0 or 1 response (71·4% vs. 25·3%, P < 0·001). CONCLUSIONS: Secukinumab demonstrated superior efficacy to FAEs in patients with psoriasis over a 24-week period.

[Internet-based "e-training" as exercise intervention for health promotion: results from 2 intervention studies]. / Internetbasiertes "e-Training" als Bewegungs-intervention zur Gesundheitsförderung: Ergebnisse aus 2 Interventionsstudien.

BACKGROUND AND AIMS: Internet-based interventions open a chance to improve the sustainability of rehabilitation in general and of exercise therapy in particular. The internet can be the sole intervention component on the one hand as well as a supportive tool for a traditional "Face-to-Face" intervention on the other hand. In this article, 2 studies in the setting of health promotion are outlined. Those studies evaluated an e-Training program in different administration forms. METHODS: Study 1: 90 adults with a sedentary lifestyle were randomized into 3 treatment groups: Group fitness ("Face-to-Face"), individually supervised training ("Face-to-Face") and e-Training (internet-based). The respective intervention took place across 3 months and each continued for a maintenance phase of 4 months. Muscular fitness, sports activities and health-related quality of life were assessed at 3 points in time: right before the intervention, after the first 3 months, and finally, after the maintenance -phase. Study 2: 509 adults with a high self-rated risk of recurrent back pain participated in the intervention "Rückengesundheit ERlangen", which lasted for 6 months: a combined program with its content delivered "Face-to-Face" and via e-Training. The analysis was conducted in a pre-post design without control group. Several psychosocial outcome variables were assessed (e.g., fear-avoidance beliefs/FABQ-D) and the cardio-pulmonary endurance capacity. RESULTS: In study 1 and in study 2, significant improvements over time in all intervention groups were measured in nearly all of the dependent variables, with the exception of the physical component summary of health-related quality of life (HRQL) (SF-36) in study 1, as well as its mental component summary (SF-36) and the endurance capacity in study 2. In study 1, the graphical comparison (confidence interval) of e-Training with the "Face-to-Face" interventions shows a similar efficacy of both of them. A gender-specific evaluation reveals that the mental component of HRQL in women is significantly more improved by the group fitness intervention than by e-Training. Study 2 shows significant positive changes in the pre-post comparison regarding psychosocial risk factors of the chronification of back pain and for men significant improvements of the endurance capacity. However, no causal link could be established because of the -limitation of the study design.

Multiple sclerosis relapses are not associated with exercise.

Since multiple sclerosis (MS) often affects physically active young individuals, it is important to know if exercise can result in increased disease activity. Therefore we used a self-report questionnaire to examine the relationship of different levels of sports activity and relapses in 632 patients with MS. In order to analyse whether subjective recall might have biased the results, we performed, in a subgroup of our sample, an objective assessment of clinical data and physical fitness parameters. We were unable to find any association between sports activity and clinical relapses in either of the two analyses. The group with highest activity even shows the lowermost mean values, standard deviations and range concerning the number of relapses. Our data suggest that physical activity has no significant influence on clinical disease activity.

Exercise and fractures in postmenopausal women: 12-year results of the Erlangen Fitness and Osteoporosis Prevention Study (EFOPS).

UNLABELLED: This trial is the first exercise study that focuses on fracture incidence as a primary study endpoint. Although we marginally failed to determine significant effects on "overall" fracture risk (p = .074) or rate ratio (p = .095), our findings further increased the evidence that exercise relevantly prevents fractures in the elderly. INTRODUCTION: The purpose of this study is to determine the effect of strictly supervised long-term exercise training on "overall" fracture incidence and bone mineral density (BMD) in postmenopausal osteopenic women. METHODS: Eighty-five early postmenopausal (1-8 years), osteopenic women living in the area of Erlangen-Nuremberg, Germany without any medication or diseases affecting bone metabolism were assessed after 12 years of supervised exercise (EG) or unvarying lifestyle (control, CG). Exercisers were encouraged to perform two group sessions/week and two home training sessions/week. Calcium and vitamin D supplementation was provided for both groups. "Overall" fractures were determined by questionnaires and structured interviews. The BMD was assessed at lumbar spine and proximal femur by dual-energy X-ray absorptiometry. RESULTS: "Overall" fracture risk ratio in the EG was 0.32 (95% confidence interval (CI), 0.08 to 1.05; p = .074), and the rate ratio for "overall" fractures was 0.38 (95% CI, 0.11 to 1.15; p = .095). BMD changes at lumbar spine (EG, -0.8%; 95% CI, 0.8% to -2.7% vs. CG, -4.0%; 95% CI, -2.4% to -5.7%; p = .011) and femoral neck (EG, -3.7%; 95% CI, -2.4% to -5.0% vs. CG, -6.7%; 95% CI, -5.3% to -8.2%; p = .003) significantly differed between both groups. CONCLUSION: Although we marginally failed to determine significant effects on overall fracture risk or rate ratio, our study increased the body of evidence for the fracture prevention efficiency of exercise programs, with special regard on bone strength (as assessed by bone mineral density measurement). Future studies should focus on subjects more prone to fractures to generate enough statistical power to clearly determine this issue.

[Effect of whole body vibration on the neuromuscular performance of females 65 years and older. One-year results of the controlled randomized ELVIS study]. / Effekte von Ganzkörpervibrationen auf die neuromuskuläre Leistungsfähigkeit von Frauen über dem 65. Lebensjahr. Einjahresergebnisse der kontrollierten randomisierten ELVIS-Studie.

Sarcopenia is linked to an increased risk of morbidity and mortality in the aging. Whole body vibration (WBV) exercises are currently discussed as a "gentle" alternative to conventional exercises to improve muscle mass. The present study scrutinized whether a multipurpose (exercise) training program using WBV can improve muscle mass and neuromuscular capacity, while lowering fall risk. A total of 151 postmenopausal women were randomized into three groups: exercise group (TG), exercise group with vibration (VTG), and fitness control group (CG). The TG group participated in an exercise program including leg strengthening training twice a week over 12 months, while the VTG carried out an identical program with the leg exercises performed under WBV. Despite a positive trend regarding lean body mass in the two exercise groups, there was no difference between groups. Both exercise groups showed a significant increase (vs. KG) in trunk strength. An improvement in both exercise groups was also measured with respect to leg strength, but only the VTG showed significant differences compared to the CG. In addition, a significant lower risk of falls compared with the CG was evident only in VTG.