Search

Supplemental material, sj-pdf-2-cep-10.1177_03331024211053571 for Erenumab versus topiramate for the prevention of migraine ��� a randomised, double-blind, active-controlled phase 4 trial by Uwe Reuter, Marc Ehrlich, Astrid Gendolla, Axel Heinze, Jan Klatt, Shihua Wen, Peggy Hours-Zesiger, Jacqueline Nickisch, Christian Sieder, Christian Hentschke and Monika Maier-Peuschel in Cephalalgia

Supplemental material, sj-pdf-3-cep-10.1177_03331024211053571 for Erenumab versus topiramate for the prevention of migraine ��� a randomised, double-blind, active-controlled phase 4 trial by Uwe Reuter, Marc Ehrlich, Astrid Gendolla, Axel Heinze, Jan Klatt, Shihua Wen, Peggy Hours-Zesiger, Jacqueline Nickisch, Christian Sieder, Christian Hentschke and Monika Maier-Peuschel in Cephalalgia

Additional file 1. Description of the 15 units of BET (closed group) with an overview of contents: education about CLBP, education about physical activity, coping with pain, and exercises.

Additional file 2. Tables with results for all secondary outcomes. Unadjusted means for the primary outcome and each secondary outcome at t1 = start of BMR, t2 = end of BMR, t3 = 6 months; t4 = 12 months for each study group.

Anna Streber, Karim Abu-Omar, Christian Hentschke, Alfred Rütten Department of Sport Science and Sport, Faculty of Humanities, Social Sciences, and Theology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany Abstract: Prevention of dementia is a public health priority. Physical activity (PA) can reduce the risk of dementia, but the majority of people remain sedentary. We conducted a multicenter controlled study with older adults (60+years). We hypothesized that an evidence-based PA intervention – GEhen, Spielen und Tanzen Als Lebenslange Tätigkeiten – kompakt [walking, playing and dancing as lifelong activities-compact] (GESTALT-kompakt) – would lead to significantly larger improvements in PA levels (step counts/Fitbit Zip™), cognitive functions (DemTect) and social activities (Social Activity Log), compared to an active control group. Data were collected at baseline and after 3 and 12 months. The intervention group received a 12-week (1/week) multimodal and multicomponent PA program, which combined PA with cognitive and social activities. The control group received either regular gymnastics or cognitive training (1/week). A mixed linear model was chosen for analysis. A total of 87 older individuals were recruited in the GESTALT-kompakt study (68 females, average age =76.0 years, SD±9.2, range 52–95 years). Marginally significant differences were observed in the intervention group (n=57) in comparison to the control group (n=30), regarding improvements in PA (difference of mean changes =866.4 steps, p=0.055) after 3 months. However, their PA decreased to the baseline score value after 12 months (-866.0 steps, p=0.061). GESTALT-kompakt did not cause significant differences in cognitive functioning (-0.8620, p=0.074) and social activities (-0.2428, p=0.288) in comparison to the control intervention from T0 to T1. Sixteen (24.2%) study participants who finished T2 reported a negative life event during the follow-up period, which severely influenced their PA behavior. GESTALT-kompakt might be effective in increasing PA in the short term, but did not have a long-term impact on the PA levels, cognitive functions or social activities of the participants. We recommend PA programs with longer duration to change behavior in the long term. Keywords: aging, intervention, physical activity program, cognitive function, social activity, dementia

Prevention of dementia is a public health priority. Physical activity (PA) can reduce the risk of dementia, but the majority of people remain sedentary. We conducted a multicenter controlled study with older adults (60+ years). We hypothesized that an evidence-based PA intervention – GEhen, Spielen und Tanzen Als Lebenslange Tätigkeiten – kompakt [walking, playing and dancing as lifelong activities-compact] (GESTALT-kompakt) – would lead to significantly larger improvements in PA levels (step counts/Fitbit Zip™), cognitive functions (DemTect) and social activities (Social Activity Log), compared to an active control group. Data were collected at baseline and after 3 and 12 months. The intervention group received a 12-week (1/week) multimodal and multicomponent PA program, which combined PA with cognitive and social activities. The control group received either regular gymnastics or cognitive training (1/week). A mixed linear model was chosen for analysis. A total of 87 older individuals were recruited in the GESTALT-kompakt study (68 females, average age =76.0 years, SD ±9.2, range 52–95 years). Marginally significant differences were observed in the intervention group (n=57) in comparison to the control group (n=30), regarding improvements in PA (difference of mean changes =866.4 steps, p=0.055) after 3 months. However, their PA decreased to the baseline score value after 12 months (−866.0 steps, p=0.061). GESTALT-kompakt did not cause significant differences in cognitive functioning (−0.8620, p=0.074) and social activities (−0.2428, p=0.288) in comparison to the control intervention from T0 to T1. Sixteen (24.2%) study participants who finished T2 reported a negative life event during the follow-up period, which severely influenced their PA behavior. GESTALT-kompakt might be effective in increasing PA in the short term, but did not have a long-term impact on the PA levels, cognitive functions or social activities of the participants. We recommend PA programs with longer duration to change behavior in the long term.

Ellen Freiberger,1 Wolfgang A Blank,2 Johannes Salb,1 Barbara Geilhof,3 Christian Hentschke,1 Peter Landendoerfer,2 Martin Halle,3 Monika Siegrist31Institute of Sport Science and Sport Universität Erlangen-Nürnberg, Nuremberg, Germany; 2Institute of General Practice, Technische Universität München, Munich, Germany; 3Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Munich, GermanyPurpose: To study the feasibility of first, reaching functionally declined, but still independent older persons at risk of falls through their general practitioner (GP) and second, to reduce their physiological and psychological fall risk factors with a complex exercise intervention. We investigated the effects of a 16-week exercise intervention on physiological (function, strength, and balance) and psychological (fear of falling) outcomes in community-dwelling older persons in comparison with usual care. In addition, we obtained data on adherence of the participants to the exercise program.Methods: Tests on physical and psychological fall risk were conducted at study inclusion, and after the 16-week intervention period in the GP office setting. The 16-week intervention included progressive and challenging balance, gait, and strength exercise as well as changes to behavioral aspects. To account for the hierarchical structure in the chosen study design, with patients nested in GPs and measurements nested in patients, a three-level linear mixed effects model was determined for analysis.Results: In total, 33 GPs recruited 378 participants (75.4% females). The mean age of the participants was 78.1 years (standard deviation 5.9 years). Patients in the intervention group showed an improvement in the Timed-Up-and-Go-test (TUG) that was 1.5 seconds greater than that showed by the control group, equivalent to a small to moderate effect. For balance, a relative improvement of 0.8 seconds was accomplished, and anxiety about falls was reduced by 3.7 points in the Falls Efficacy Scale–International (FES-I), in the intervention group relative to control group. In total, 76.6% (N = 170) of the intervention group participated in more than 75% the supervised group sessions.Conclusion: The strategy to address older persons at high risk of falling in the GP setting with a complex exercise intervention was successful. In functionally declined, community-dwelling, older persons a complex intervention for reducing fall risks was effective compared with usual care.Keywords: complex exercise intervention, functional declined community-dwelling older persons

Falls and fall-related injuries are common in community-dwelling elderly people. Effective multifactorial fall prevention programs in the primary care setting may be a promising approach to reduce the incidence rate of falls.In a cluster randomized trial in 33 general practices 378 people living independently and at high risk of falling (65 to 94 years old; 285 women) were allocated to either a 16 week exercise-based fall prevention program including muscle strengthening and challenging balance training exercises, combined with a 12 week home-based exercise program (222 participants), or to usual care (156 participants). The main outcome was number of falls over a period of 12 months. Secondary outcomes were the number of fall-related injuries, physical function (Timed-Up-and-Go-Test, TUG, Chair-Stand-Test, CST, modified Romberg Test), and fear of falling.In the intervention group (n=222 patients in 17 general practices) 291 falls occurred, compared to 367 falls in the usual care group (n=156 patients in 16 general practices). We observed a lower incidence rate for falls in the intervention group (incidence rate ratio/IRR: 0.54; 95% confidence interval (CI): [0.35; 0.84], p=0.007) and for fall-related injuries (IRR: 0.66; [0.42; 0.94], p=0.033). Additionally, patients in the intervention group showed significant improvements in secondary endpoints (TUG: -2.39 s, [-3.91; -0.87], p=0.014; mRomberg: 1.70 s, [0.35; 3.04], p=0.037; fear of falling: -2.28 points, [-3.87; -0.69], p=0.022) compared to usual care.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.

ObjectivesThe aim of this study was to evaluate the mean heart rate and heart rate variability (HRV) required for diagnostic imaging of the coronary arteries simultaneously with thoracic computed tomography for noncardiac purposes, applying a high-pitch spiral image acquisition protocol for computed tomography angiography (CTA) using a dual-source system.BackgroundFor the primary prevention of coronary heart disease, screening methods to identify currently asymptomatic people who are at high risk for developing coronary heart disease are essential. Coronary CTA can rule out coronary artery stenoses with high negative predictive value.MethodsHigh-pitch thoracic computed tomography was performed in 111 consecutive patients (mean age 60.2 ± 11.5 years; range 37 to 81 years) using a dual-source system (2 × 128 0.6-mm sections, 38.4-mm collimation width, 0.28-s rotation time). Data acquisition was prospectively electrocardiographically triggered at 60% of the R-R interval using a pitch of 3.2. Image quality was evaluated using a 3-point scale (1 = excellent, 2 = moderate, 3 = poor).ResultsClose interobserver agreement for image quality scores of 1,998 evaluated coronary segments was found (κ = 0.93). Image quality was of diagnostic value in 828 of 1,739 segments (47.6%). In 29 of 111 patients (26%), diagnostic image quality was observed for all segments. Average heart rate and HRV were significantly (p < 0.001) higher in patients with at least 1 nondiagnostic coronary segment compared with those without. All patients with mean heart rates

Background Although 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. Methods 69 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. Results For 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. Conclusions The 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 registration This trial has been registered with clinicaltrials.gov (NCT00783159)