Background We compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults. Methods HER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50–100 mg/day) plus erenumab placebo (topiramate group). The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint. Results Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13–0.27; p < 0.001). Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06–3.71; p < 0.001). No new safety signals occurred. Conclusions Erenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate. Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539
BackgroundAlthough resistance exercise interventions have been shown to be beneficial in prefrail or frail older adults it remains unclear whether there are residual effects when the training is followed by a period of detraining. The aim of this study was to establish the sustainability of a muscle power or muscle strength training effect in prefrail older adults following training and detraining.Methods69 prefrail community-dwelling older adults, aged 65–94 years were randomly assigned into three groups: muscle strength training (ST), muscle power training (PT) or controls. The exercise interventions were performed for 60 minutes, twice a week over 12 weeks. Physical function (Short Physical Performance Battery=SPPB), muscle power (sit-to-stand transfer=STS), self-reported function (SF-LLFDI) and appendicular lean mass (aLM) were measured at baseline and at 12, 24 and 36 weeks after the start of the intervention.ResultsFor the SPPB, significant intervention effects were found at 12 weeks in both exercise groups (ST: p = 0.0047; PT: p = 0.0043). There were no statistically significant effects at 24 and 36 weeks. In the ST group, the SPPB declined continuously after stop of exercising whereas the PT group and controls remained unchanged. No effects were found for muscle power, SF-LLFDI and aLM.ConclusionsThe results showed that both intervention types are equally effective at 12 weeks but did not result in statistically significant residual effects when the training is followed by a period of detraining. The unchanged SPPB score at 24 and 36 weeks in the PT group indicates that muscle power training might be more beneficial than muscle strength training. However, more research is needed on the residual effects of both interventions. Taken the drop-out rates (PT: 33%, ST: 21%) into account, muscle power training should also be used more carefully in prefrail older adults.Trial registrationThis trial has been registered with clinicaltrials.gov (NCT00783159)
A complex falls prevention program in a primary care setting was effective in reducing falls and fall-related injuries in community dwelling older adults at risk.
Physical exercise is effective in improving functional outcomes in persons with multiple sclerosis (pwMS). We evaluated the feasibility and effectiveness of internet-based exercise training (e-training) for pwMS on health-related quality of life (HrQoL). Secondary outcomes were muscle strength, aerobic capacity, lung function, physical activity, and fatigue. This is a randomised, controlled trial with a wait-list control group. Data were collected at baseline, after three and six months, and analysed using a hybrid linear model. One-hundred twenty-six pwMS participated in the home-based aerobic (1×/week) and strength training (2×/week) intervention that was supervised and documented via an internet-platform. The intervention group received e-training for six months, and the control group received e-training after a three months waiting period. Significant differences between the groups were only observed for muscle strength (knee flexion (effect size ES = 0.3, p = 0.003), knee extension (ES = 0.24, p = 0.015)), peak expiratory flow (ES = 0.2, p = 0.039), and sports activity (ES = 0.33, p = 0.001) after three months. E-training had no effect on HrQoL but did on muscle strength, lung function, and physical activity. It is a promising and feasible approach to facilitate large-scale, yet individual, training support.
In team sports, sensorimotor impairments resulting from previous injuries or muscular fatigue have been suggested to be factors contributing to an increased injury risk. Although it has been widely shown that physical fatigue affects static postural sway, it is still questionable as to what extent these adaptations are relevant for dynamic, sports-related situations. The objective of this study was to determine the effects of whole-body and localized fatigue on postural control in stable and unstable conditions. Nineteen male team handball players were assessed in 2 sessions separated by 1 week. Treadmill running and single-leg step-up exercises were used to induce physical fatigue. The main outcome measures were center of pressure (COP) sway velocity during a single-leg stance on a force plate and maximum reach distances of the star excursion balance test (SEBT). The COP sway velocity increased significantly (p < 0.05) after general (+47%) and localized fatigue (+10%). No fatigue effects were found for the SEBT. There were no significant correlations between COP sway velocity and SEBT mean reach in any condition. The results showed that although fatigue affects static postural control, sensorimotor mechanisms responsible for regaining dynamic balance in healthy athletes seem to remain predominantly intact. Thus, our data indicate that the exclusive use of static postural sway measures might not be sufficient to allow conclusive statements regarding sensorimotor control in the noninjured athlete population.
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