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Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study.
Castelnovo, G, Gerlach, O, Freedman, MS, Bergmann, A, Sinay, V, Castillo-Triviño, T, Kong, G, Koster, T, Williams, H, Gafson, AR, et al
CNS drugs. 2021;(9):1009-1022
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Abstract
BACKGROUND Prolonged-release fampridine (PR-FAM) 10-mg tablet twice daily is the only approved pharmacological treatment for improvement of walking ability in adults with multiple sclerosis (MS). LIBERATE assessed the safety/effectiveness of PR-FAM in the real-world. OBJECTIVES The aim of this study was to collect additional safety data, including the incidence rate of seizures and other adverse events (AEs) of interest, from patients with MS taking PR-FAM in routine clinical practice (including patients aged ≥ 65 years and those with pre-existing cardiovascular risk factors). Other objectives included change over time in patient-reported evaluation of physical and psychological impact of MS while taking PR-FAM, and change over time in physician-reported assessment of walking ability in MS patients taking PR-FAM. METHODS Patients with MS newly prescribed PR-FAM were recruited (201 sites, 13 countries). Demographic/safety data were collected at enrolment through 12 months. Physician-rated Clinical Global Impression of Improvement (CGI-I) scores for walking ability, and Multiple Sclerosis Impact Scale-29 (MSIS-29) were assessed. RESULTS Safety analysis included 4646 patients with 3534.8 patient-years of exposure; median (range) age, 52.6 (21-85) years, 87.3% < 65 years, and 65.7% women. Treatment-emergent AEs (TEAEs) were reported in 2448 (52.7%) patients, and serious TEAEs were reported in 279 (6.0%) patients, of whom 37 (< 1%) experienced treatment-emergent serious AEs (TESAEs) considered related to PR-FAM. AEs of special interest (AESI) occurred in 1799 (38.7%) patients, and serious AESI in 128 (2.8%) patients. Seventeen (< 1%) patients experienced actual events of seizure. Overall, 1158 (24.9%) patients discontinued treatment due to lack of efficacy. At 12 months, a greater proportion of patients on-treatment had improvement from baseline in CGI-I for walking ability versus those who discontinued (61% vs. 11%; p < 0.001). MSIS-29 physical impact score improved significantly for patients on-treatment for 12 months versus those who discontinued (mean change, baseline to 12 months: - 9.99 vs. - 0.34 points; p < 0.001). Results were similar for MSIS-29 psychological impact. CONCLUSION No new safety concerns were identified in this real-world study, suggesting that routine risk-minimization measures are effective. CGI-I and MSIS-29 scores after 12 months treatment with PR-FAM treatment show clinical benefits consistent with those previously reported. TRIAL REGISTRATION ClinicalTrials.gov: NCT01480063.
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Active and sedentary bouts in people after stroke and healthy controls: An observational study.
Hassett, L, Ada, L, Hellweg, S, Paul, S, Alzahrani, M, Dean, C
Physiotherapy research international : the journal for researchers and clinicians in physical therapy. 2020;(3):e1845
Abstract
BACKGROUND AND PURPOSE Understanding how both active and sedentary time is accumulated in people after stroke may help to better target interventions to reduce stroke recurrence. This study aimed to determine the difference between stroke and healthy controls in (a) time spent in sedentary and active behaviour, (b) frequency of short and long active and sedentary bouts and (c) time spent in short and long active and sedentary bouts. METHODS Analysis of secondary outcomes from a cross-sectional study. Participants were 42 community-dwelling people after stroke and 21 age-matched healthy controls. An activity monitor was used to collect free-living active and sedentary behaviour. Total active (standing and walking) and sedentary (lying, reclining and sitting) time was calculated in minutes per day. Bouts were categorized as short (<5 min, 5-15 min, 15-30 min) or long (>30 min). The frequency of and time spent in each bout were calculated. RESULTS Relative to wear time, the stroke group spent 10% (95% confidence interval [CI] 3 to 17) more time in sedentary behaviour and had fewer long active bouts than the healthy controls. The stroke group spent 7% (95% CI 1-13) less time in long active bouts and 11% (95% CI 2-20) more time in long sedentary bouts than the healthy controls. CONCLUSIONS Community-dwelling people after stroke spent less time in active behaviour and accumulated more sedentary time in bouts longer than 30 min compared with healthy controls. Increasing active time and breaking up long sedentary time warrants investigation in people after stroke.
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A trajectory analysis of daily step counts during a physician-delivered intervention.
Cooke, AB, Rahme, E, Defo, AK, Chan, D, Daskalopoulou, SS, Dasgupta, K
Journal of science and medicine in sport. 2020;(10):962-967
Abstract
OBJECTIVES Higher steps are associated with lower mortality and cardiovascular event rates. We previously demonstrated that tailored physician-delivered step count prescriptions successfully increased steps/day in adults with type 2 diabetes mellitus (T2DM) and/or hypertension. In the present analysis, we examined patterns of step count change and the factors that influence different responses. DESIGN Longitudinal observational study METHODS Active arm participants (n=118) recorded steps/day. They received a step count prescription from their physician every 3-4 months. We computed mean steps/day and changes from baseline for sequential 30-day periods. Group-based trajectory modeling was applied. RESULTS Four distinct trajectories of mean steps/day emerged, distinguishable by differences in baseline steps/day: sedentary (19%), low active (40%), somewhat active (30%) and active (11%). All four demonstrated similar upward slopes. Three patterns emerged for the change in steps from baseline: gradual decrease (30%), gradual increase with late decline (56%), and rapid increase with midpoint decline (14%); thus 70% had an increase from baseline. T2DM (odd ratios [OR]: 3.7, 95% CI 1.7, 7.7) and age (OR per 10-year increment: 2, 95% CI 1.3, 2.8) were both associated with starting at a lower baseline but participants from these groups were no less likely than others to increase steps/day. CONCLUSIONS T2DM and older age were associated with lower baseline values but were not indicators of likelihood of step count increases. A physician-delivered step count prescription and monitoring strategy has strong potential to be effective in increasing steps irrespective of baseline counts and other clinical and demographic characteristics.
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Caloric consumption during early mobilisation of mechanically ventilated patients in Intensive Care Units.
Nydahl, P, Schuchhardt, D, Jüttner, F, Dubb, R, Hermes, C, Kaltwasser, A, Mende, H, Müller-Wolff, T, Rothaug, O, Schreiber, T
Clinical nutrition (Edinburgh, Scotland). 2020;(8):2442-2447
Abstract
OBJECTIVE To evaluate a) the magnitude of the increase in caloric consumption due to early mobilisation of patients with mechanical ventilation (MV) in Intensive Care Units (ICU) as part of routine care, b) whether there are differences in caloric consumption due to active or passive mobilisation, and c) whether early mobilisation in routine care would lead to additional nutritional requirements. DESIGN Prospective, observational, multi-centre study. SETTING Medical, surgical and neurological ICUs from three centres. PATIENTS Patients on MV in ICU who were mobilised out of bed as part of routine care. MEASUREMENTS AND MAIN RESULTS Caloric consumption was assessed in 66 patients by indirect calorimetry at six time points: (1) lying in bed 5-10 min prior to mobilisation, (2) sitting on the edge of the bed, (3) standing beside the bed, (4) sitting in a chair, (5) lying in bed 5-10 min after mobilisation, and (6) 2 h after mobilisation. Differences in caloric consumption in every mobilisation level vs. the baseline of lying in bed were measured for 5 min and found to have increased significantly by: +0.4 (Standard Deviation (SD) 0.59) kcal while sitting on the edge of the bed, +1.5 (SD 1.26) kcal while standing in front of the bed, +0.7 (SD 0.63) kcal while sitting in a chair (all p < 0.001). Active vs. passive transfers showed a higher, but non-significant consumption. A typical sequence of mobilisation including sitting on edge of the bed, standing beside the bed, sitting in a chair (20 min) and transfer back into bed, would require an additional 4.56 kcal compared to caloric consumption without mobilisation. CONCLUSIONS Based on this data, routine mobilisation of MV patients in ICU increases caloric consumption, especially in active mobilisation. Nevertheless, an additional caloric intake because of routine mobilisation does not seem to be necessary.
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Prospectively Reallocating Sedentary Time: Associations with Cardiometabolic Health.
Yates, T, Edwardson, CL, Henson, J, Zaccardi, F, Khunti, K, Davies, MJ
Medicine and science in sports and exercise. 2020;(4):844-850
Abstract
PURPOSE This study aimed to investigate whether prospectively reallocating time away from sedentary behavior (SB) into different physical activity intensities is associated with 12-month change to cardiometabolic health in a cohort at high risk of type 2 diabetes (T2DM). METHODS Participants with known risk factors for T2DM were recruited from primary care (Leicestershire, United Kingdom) as part of the Walking Away from Type 2 Diabetes trial (n = 808). Participants were followed up at 12, 24, and 36 months. SB, light-intensity physical activity (LPA) and moderate-to-vigorous intensity physical activity (MVPA) were measured objectively by accelerometer. Postchallenge glucose, triglycerides, HDL cholesterol, systolic blood pressure, and waist circumference were analyzed individually and combined into a clustered cardiometabolic risk score (CMRS). Associations of changing SB over each consecutive 12-month period were analyzed taking account of repeated measures. RESULTS Reallocating 30 min from SB to LPA was associated with 0.21-cm (95% confidence interval, 0.03-0.38 cm) reduction in waist circumference, 0.09-mmol·L (0.04-0.13 mmol·L) reduction in 2-h glucose, 0.02-mmol·L (0.00-0.04 mmol·L) reduction in triglycerides, and 0.02 (0.01-0.03) reduction in CMRS. Every 30-min reallocation from SB to MVPA was associated with 1.23-cm (0.68-1.79 cm) reduction in waist circumference, 0.23-mmol·L (0.10-0.36 mmol·L) reduction in 2-h glucose, 0.04-mmol·L (0.00-0.09 mmol·L) reduction in triglycerides, and 0.07 (0.04-0.11) reduction in CMRS. Reallocating 30 min from LPA into MVPA was also associated with 1.02-cm (0.43-1.60 cm) reduction in waist circumference, 0.16-mmol·L (0.02-0.30 mmol·L) reduction in 2-h glucose, and 0.05 (0.01-0.09) reduction in CMRS. CONCLUSION Over 12 months, reallocating time away from SB into LPA or MVPA was associated with improved cardiometabolic health in a population at risk of T2DM, with the greatest benefits observed for MVPA.
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Heart Rate Recovery, Physical Activity Level, and Functional Status in Subjects With COPD.
Morita, AA, Silva, LKO, Bisca, GW, Oliveira, JM, Hernandes, NA, Pitta, F, Furlanetto, KC
Respiratory care. 2018;(8):1002-1008
Abstract
BACKGROUND A normal heart rate reflects the balance between the sympathetic and parasympathetic autonomic nervous system. When the difference between heart rate at the end of an exercise test and after 1 min of recovery, known as the 1-min heart rate recovery, is ≤ 12 beats/min, this may indicate an abnormal delay. We sought to compare physical activity patterns and subjects' functional status with COPD with or without delayed 1-min heart rate recovery after the 6-min walk test (6MWT). METHODS 145 subjects with COPD (78 men, median [interquartile range (IQR)] age 65 [60-73] y, body mass index 25 [21-30] kg/m2, FEV1 45 ± 15% predicted) were underwent the following assessments: spirometry, 6MWT, functional status, and physical activity in daily life (PADL). A delayed heart rate recovery of 1 min was defined as ≤ 12 beats/min. RESULTS Subjects with delayed 1-min heart rate recovery walked a shorter distance in the 6MWT compared to subjects without delayed heart rate recovery (median [IQR] 435 [390-507] m vs 477 [425-515] m, P = .01; 81 [71-87] vs 87 [79-98]% predicted, P = .002). Regarding PADL, subjects with delayed heart rate recovery spent less time in the standing position (mean ± SD 185 ± 89 min vs 250 ± 107 min, P = .002) and more time in sedentary positions (472 ± 110 min vs 394 ± 129 min, P = .002). Scores based on the self-care domain of the London Chest Activity of Daily Living questionnaire and the activity domain of the Pulmonary Functional Status and Dyspnea questionnaire were also worse in the group with delayed heart rate recovery (6 ± 2 points vs 5 ± 2 points; P = .039 and 29 ± 24 points vs 19 ± 17 points; P = .037, respectively). CONCLUSIONS Individuals with COPD who exhibit delayed 1-min heart rate recovery after the 6MWT exhibited worse exercise capacity as well as a more pronounced sedentary lifestyle and worse functional status than those without delayed heart rate recovery. Despite its assessment simplicity, heart rate recovery after the 6MWT can be further explored as a promising outcome in COPD.
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Neighborhood educational disparities in active commuting among women: the effect of distance between the place of residence and the place of work/study (an ACTI-Cités study).
Perchoux, C, Nazare, JA, Benmarhnia, T, Salze, P, Feuillet, T, Hercberg, S, Hess, F, Menai, M, Weber, C, Charreire, H, et al
BMC public health. 2017;(1):569
Abstract
BACKGROUND Active transportation has been associated with favorable health outcomes. Previous research highlighted the influence of neighborhood educational level on active transportation. However, little is known regarding the effect of commuting distance on social disparities in active commuting. In this regard, women have been poorly studied. The objective of this paper was to evaluate the relationship between neighborhood educational level and active commuting, and to assess whether the commuting distance modifies this relationship in adult women. METHODS This cross-sectional study is based on a subsample of women from the Nutrinet-Santé web-cohort (N = 1169). Binomial, log-binomial and negative binomial regressions were used to assess the associations between neighborhood education level and (i) the likelihood of reporting any active commuting time, and (ii) the share of commuting time made by active transportation modes. Potential effect measure modification of distance to work on the previous associations was assessed both on the additive and the multiplicative scales. RESULTS Neighborhood education level was positively associated with the probability of reporting any active commuting time (relative risk = 1.774; p < 0.05) and the share of commuting time spent active (relative risk = 1.423; p < 0.05). The impact of neighborhood education was greater at long distances to work for both outcomes. CONCLUSIONS Our results suggest that neighborhood educational disparities in active commuting tend to increase with commuting distance among women. Further research is needed to provide geographically driven guidance for health promotion intervention aiming at reducing disparities in active transportation among socioeconomic groups.
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Sitting time and physical activity after stroke: physical ability is only part of the story.
English, C, Healy, GN, Coates, A, Lewis, LK, Olds, T, Bernhardt, J
Topics in stroke rehabilitation. 2016;(1):36-42
Abstract
BACKGROUND Understanding factors that influence the amount of time people with stroke spend sitting and being active is important to inform the development of targeted interventions. OBJECTIVE To explore the physical, cognitive, and psychosocial factors associated with daily sitting time and physical activity in people with stroke. METHOD Secondary analysis of an observational study (n = 50, mean age 67.2 ± 11.6 years, 33 men) of adults at least 6 months post-stroke. Activity monitor data were collected via a 7-day, continuous wear (24 hours/day) protocol. Sitting time [total, and prolonged (time in bouts of ≥ 30 minutes)] was measured with an activPAL3 activity monitor. A hip-worn Actigraph GT3X+ accelerometer was used to measure moderate-to-vigorous-intensity physical activity (MVPA) time. Univariate analyses examined relationships of stroke severity (National Institutes of Health Stroke Scale), physical [walking speed, Stroke Impact Scale (SIS) physical domain score], cognitive (Montreal Cognitive Assessment), and psychosocial factors (living arrangement, SIS emotional domain score) with sitting time, prolonged sitting time, and MVPA. RESULTS Self-reported physical function and walking speed were negatively associated with total sitting time (r = - 0.354, P = 0.022 and r = - 0.361, P = 0.011, respectively) and prolonged sitting time (r = - 0.5, P = 0.001 and - 0.45, P = 0.001, respectively), and positively associated with MVPA (r = 0.469, P = 0.002 and 0.431, P = 0.003, respectively). CONCLUSIONS Physical factors, such as walking ability, may influence sitting and activity time in people with stroke, yet much of the variance in daily sitting time remains unexplained. Large prospective studies are required to understand the drivers of activity and sitting time.
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Glycemic control during consecutive days with prolonged walking exercise in individuals with type 1 diabetes mellitus.
van Dijk, JW, Eijsvogels, TM, Nyakayiru, J, Schreuder, TH, Hopman, MT, Thijssen, DH, van Loon, LJ
Diabetes research and clinical practice. 2016;:74-81
Abstract
AIMS: Despite its general benefits for health, exercise complicates the maintenance of stable blood glucose concentrations in individuals with type 1 diabetes. The aim of the current study was to examine changes in food intake, insulin administration, and 24-h glycemic control in response to consecutive days with prolonged walking exercise (∼8h daily) in individuals with type 1 diabetes. METHODS Ten individuals with type 1 diabetes participating in the worlds' largest walking event were recruited for this observational study. Simultaneous measurements of 24-h glycemic control (continuous glucose monitoring), insulin administration and food intake were performed during a non-walking day (control) and during three subsequent days with prolonged walking exercise (daily distance 40 or 50km). RESULTS Despite an increase in daily energy (31±18%; p<0.01) and carbohydrate (82±71g; p<0.01) intake during walking days, subjects lowered their insulin administration by 26±16% relative to the control day (p<0.01). Average 24-h blood glucose concentrations, the prevalence of hyperglycemia (blood glucose >10 mmol/L) and hypoglycemia (blood glucose <3.9mmol/L) did not differ between the control day and walking days (p>0.05 for all variables). The prolonged walking exercise was associated with a modest increase in glycemic variability compared with the control day (p<0.05). CONCLUSION Prolonged walking exercise allows for profound reductions in daily insulin administration in persons with type 1 diabetes, despite large increments in energy and carbohydrate intake. When taking such adjustments into account, prolonged moderate-intensity exercise does not necessarily impair 24-h glycemic control.
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Cognitive-Motor Related Brain Activity During Walking: Differences Between Men and Women With Multiple Sclerosis.
Hebert, JR, Kindred, JH, Bucci, M, Tuulari, JJ, Brenner, LA, Forster, JE, Koo, PJ, Rudroff, T
Archives of physical medicine and rehabilitation. 2016;(1):61-6
Abstract
OBJECTIVE To determine if sex differences in glucose uptake, a marker of brain activity, are present in brain regions that facilitate walking performance in persons with multiple sclerosis (MS). DESIGN Cross-sectional, observational pilot. SETTING University laboratory. PARTICIPANTS Positron emission tomography with fluorine-18-labeled deoxyglucose (FDG) was performed on persons with MS and healthy controls (4 men and 4 women per group; N=16) after a 15-minute walking test. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURE Brain activity was quantified as the mean standardized uptake value (SUV). RESULTS The mean SUV was significantly lower in the thalamus (P=.029) and cerebellum (P=.029) for men with MS compared with women with MS, but not for the prefrontal (P=.057) or frontal (P=.057) cortices. Similar nonsignificant trends were found for healthy controls. No mean SUV group × sex interaction effects were found between the MS and healthy control groups (all P>.05). CONCLUSIONS To our knowledge, this is the first study of brain activity sex differences based on FDG uptake in persons with MS during walking. Significantly less FDG uptake in the thalamus and cerebellum brain regions important for walking performance was found in men with MS compared with women with MS; however, these comparisons were not significantly different in the healthy control group. No differences in FDG uptake were found between the MS and healthy control groups in any of the brain regions examined. Results from this study provide pilot data for larger studies aimed at identifying underlying mechanisms responsible for accelerated disability in men with MS.