A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project.

BackgroundIn nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents.MethodsA three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated.DiscussionThis study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations.Trial registrationThe trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217)

Supplementary Material for: Effects of Wearable Sensor-Based Balance and Gait Training on Balance, Gait, and Functional Performance in Healthy and Patient Populations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

<p><b><i>Background:</i></b> Wearable sensors (WS) can accurately measure body motion and provide interactive feedback for supporting motor learning. <b><i>Objective:</i></b> This review aims to summarize current evidence for the effectiveness of WS training for improving balance, gait and functional performance. <b><i>Methods:</i></b> A systematic literature search was performed in PubMed, Cochrane, Web of Science, and CINAHL. Randomized controlled trials (RCTs) using a WS exercise program were included. Study quality was examined by the PEDro scale. Meta-analyses were conducted to estimate the effects of WS balance training on the most frequently reported outcome parameters. <b><i>Results:</i></b> Eight RCTs were included (Parkinson <i>n</i> = 2, stroke <i>n</i> = 1, Parkinson/stroke <i>n</i> = 1, peripheral neuropathy <i>n</i> = 2, frail older adults <i>n</i> = 1, healthy older adults <i>n</i> = 1). The sample size ranged from <i>n</i> = 20 to 40. Three types of training paradigms were used: (1) static steady-state balance training, (2) dynamic steady-state balance training, which includes gait training, and (3) proactive balance training. RCTs either used one type of training paradigm (type 2: <i>n</i> = 1, type 3: <i>n</i> = 3) or combined different types of training paradigms within their intervention (type 1 and 2: <i>n</i> = 2; all types: <i>n</i> = 2). The meta-analyses revealed significant overall effects of WS training on static steady-state balance outcomes including mediolateral (eyes open: Hedges' <i>g</i> = 0.82, CI: 0.43-1.21; eyes closed: <i>g</i> = 0.57, CI: 0.14-0.99) and anterior-posterior sway (eyes open: <i>g</i> = 0.55, CI: 0.01-1.10; eyes closed: <i>g</i> = 0.44, CI: 0.02-0.86). No effects on habitual gait speed were found in the meta-analysis (<i>g</i> = -0.19, CI: -0.68 to 0.29). Two RCTs reported significant improvements for selected gait variables including single support time, and fast gait speed. One study identified effects on proactive balance (Alternate Step Test), but no effects were found for the Timed Up and Go test and the Berg Balance Scale. Two studies reported positive results on feasibility and usability. Only one study was performed in an unsupervised setting. <b><i>Conclusion:</i></b> This review provides evidence for a positive effect of WS training on static steady-state balance in studies with usual care controls and studies with conventional balance training controls. Specific gait parameters and proactive balance measures may also be improved by WS training, yet limited evidence is available. Heterogeneous training paradigms, small sample sizes, and short intervention durations limit the validity of our findings. Larger studies are required for estimating the true potential of WS technology.</p

The association of basic and challenging motor capacity with mobility performance and falls in young seniors

Background: Understanding the association between motor capacity (MC) (what people can do in a standardized environment), mobility performance (MP) (what people actually do in real-life) and falls is important for early detection of and counteracting on functional decline, particularly in the rapidly growing population of young seniors. Therefore, this study aims to 1) explore the association between MC and MP, and between MC and falls, and 2) investigate whether challenging MC measures are better associated with MP and falls than basic MC measures. Methods: Basic (habitual gait speed, Timed Up-and-Go) and challenging (fast gait speed, Community Balance &amp; Mobility Scale) MC measures were performed in 169 young seniors (61\u201370 years). MP was assessed using one-week sensor-monitoring including time being sedentary, light active, and at least moderately active. Falls in the previous six months were reported. Associations and discriminative ability were calculated using correlation, regression and receiver operating curve analysis. Results: Mean age was 66.4 (SD 2.4) years (50.6 % women). Small to moderate associations (r = 0.06 120.31; p &lt; .001\u2013.461) were found between MC, MP and falls. Challenging MC measures showed closer associations with MP and falls (r = 0.10 120.31; p &lt; .001\u2013.461) compared to basic (r = 0.06 120.22; p = .012\u2013.181), remained significant in three out of four regression models explaining 2.5\u20138.6 % of the variance, and showed highest discriminative ability (area under the curve = 0.59 120.70) in all analyses. Conclusions: Challenging MC measures are closer associated with mobility performance and falls as compared to basic MC measures in young seniors. This indicates the importance of applying challenging motor capacity assessments in young seniors. On the same note, small to moderate associations imply a need for an assessment of both MC and MP in order to capture the best possible MC and the actual daily-life MP in young seniors

Zafirlukast improves asthma control in patients receiving high-dose inhaled corticosteroids

Not all asthma can be adequately controlled, despite the use of high-dose inhaled corticosteroids. Because cysteinyl-leukotrienes (Cys-LT) have been implicated in the pathogenesis of asthma, we hypothesized that the leukotriene receptor antagonist zafirlukast, in combination with high-doses of inhaled corticosteroids, might be efficacious in severe asthma. In a double-blind, parallel group study, 368 chronic adult asthmatic patients treated with inhaled corticosteroids (1,000 to 4,000 μg/d), who had a predefined level of asthma symptoms during the run in period of the study, were randomly assigned to receive additional treatment with a high dose of zafirlukast (80 mg twice daily) (n = 180) or placebo (n = 188) for 6 wk. Compared with placebo, zafirlukast produced a significant improvement over baseline in the primary study endpoint of mean morning peak expiratory flow rate (PEFR) (18.7 L/min versus 1.5 L/min, p &lt; 0.001), as well as in evening PEFR (p &lt; 0.01), FEV1 (p &lt; 0.05), daytime symptom score (p &lt; 0.001), and β2-agonist use (p &lt; 0.001). Furthermore, zafirlukast significantly reduced the risk of an exacerbation of asthma (odds ratio [OR]: 0.61; 95% confidence interval [CI]: 0.38 to 0.99) and the risk of patients requiring a further increase in asthma controller therapy (OR: 0.4; 95% CI; 0.2 to 0.8). In conclusion, in patients taking high-dose inhaled corticosteroids, zafirlukast improves pulmonary function and asthma symptoms, and reduces the risk of an asthma exacerbation, suggesting that the contribution of leukotrienes to asthma symptoms and exacerbations is not adequately controlled by high-dose inhaled corticosteroids