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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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Effect of a multicomponent nutritional supplement on functional outcomes for Duchenne muscular dystrophy: A randomized controlled trial.
Davidson, ZE, Hughes, I, Ryan, MM, Kornberg, AJ, Cairns, AG, Jones, K, Hutchence, M, Sampaio, H, Morrison, M, Truby, H
Clinical nutrition (Edinburgh, Scotland). 2021;(7):4702-4711
Abstract
BACKGROUND & AIMS Duchenne muscular dystrophy (DMD) is an X-linked neuromuscular condition causing progressive muscle weakness and premature death. Whilst effective treatments such as gene therapy are developed, families often seek complementary therapies such as nutrition supplements to help their son maintain function; however, there is limited evidence supporting the use of nutritional supplements in DMD. This study aimed to compare the effect of a Standard nutritional supplement with an Enhanced nutritional supplement combining three nutriceuticals on functional outcomes in ambulatory boys with Duchenne muscular dystrophy (DMD). DESIGN A 50-week double blinded, randomized, controlled crossover trial was conducted in four Australian neuromuscular centres. Primary outcome measures were 6-min walk distance (6MWD) and community ambulation (StepWatch™ Activity Monitoring). Secondary outcome measures included body composition and quality of life. Serum 25-hydroxyvitamin D was measured. RESULTS Twenty-seven boys completed the intervention. Traditional crossover analysis demonstrated the Enhanced supplement compared to the Standard supplement was associated with a difference of +12 (95% CI: -16, 40) metres in 6MWD, +0.5 (95% CI: -53, 54) inactive minutes per day and -95 (95% CI: -887, 696) steps per day. A mixed effect model indicated a potentially clinically important effect of the Enhanced supplement on the 6MWD of +31 (95% CI: -19, 81) metres. Mean serum 25 hydroxyvitamin D levels at week 50 was 94 (95% CI: 84, 104) nmol/L. There was no observable effect of either supplement regime on body composition or quality of life. CONCLUSIONS Whilst a positive effect of the Enhanced supplement on functional outcomes was observed, this finding was inconclusive due to the small sample size. The results do not support the use of combined nutritional supplements to improve body composition or quality of life in DMD. A dose of 2000 IU vitamin D was an adequate dose to raise serum 25-hydroxyvitamin D over 50 weeks. CLINICAL TRIAL REGISTRY Registry #: ACTRN12610000462088, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12610000462088.
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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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A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial.
Freedland, SJ, Howard, L, Allen, J, Smith, J, Stout, J, Aronson, W, Inman, BA, Armstrong, AJ, George, D, Westman, E, et al
Prostate cancer and prostatic diseases. 2019;(3):428-437
Abstract
PURPOSE The objective of this study was to test a low-carbohydrate diet (LCD) plus walking to reduce androgen deprivation therapy (ADT)-induced metabolic disturbances. MATERIALS AND METHODS This randomized multi-center trial of prostate cancer (PCa) patients initiating ADT was designed to compare an LCD (≤20g carbohydrate/day) plus walking (≥30 min for ≥5 days/week) intervention vs. control advised to maintain usual diet and exercise patterns. Primary outcome was change in insulin resistance by homeostatic model assessment at 6 months. To detect 20% reduction in insulin resistance, 100 men were required. The study was stopped early after randomizing 42 men due to slow accrual. Secondary outcomes included weight, body composition, lipids, and prostate-specific antigen (PSA). Changes from baseline were compared between arms using rank-sum tests. RESULTS At 6 months, LCD/walking reduced insulin resistance by 4% vs. 36% increase in control (p = 0.13). At 3 months, vs. control, LCD/walking arm significantly lost weight (7.8kg; p<0.001), improved insulin resistance (↑36%; p = 0.015), hemoglobin A1c (↓3.3%; p = 0.01), high-density lipoprotein (HDL) (↑13%; p = 0.004), and triglyceride (↓37%; p = 0.036). At 6 months, weight loss (10.6kg; p<0.001) and HDL (↑27%; p = 0.003) remained significant. LCD/walking preserved total body bone mineral count (p = 0.025), reduced fat mass (p = 0.002), lean mass (p = 0.036), and percent body fat (p = 0.004). There were no differences in PSA. Limitations include the effect of LCD, weight loss vs. walking instruction are indistinguishable, and small sample size. CONCLUSIONS In an underpowered study, LCD/walking did not improve insulin sensitivity at 6 months. Given most secondary outcomes were improved at 3 months with some remaining improved at 6 months and a secondary analysis showed that LCD/walking reduced insulin resistance over the study, supporting future larger studies of LCD/walking intervention to reduce ADT-induced disturbances.
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Minimal effect of walking before dinner on glycemic responses in type 2 diabetes: outcomes from the multi-site E-PAraDiGM study.
Rees, JL, Chang, CR, François, ME, Marcotte-Chénard, A, Fontvieille, A, Klaprat, ND, Dyck, RA, Funk, DR, Snydmiller, G, Bastell, K, et al
Acta diabetologica. 2019;(7):755-765
Abstract
AIM: To examine the effect of walking before dinner on 24-h glycemic control in individuals with type 2 diabetes using the standardized multi-site Exercise-Physical Activity and Diabetes Glucose Monitoring (E-PAraDiGM) Protocol. METHODS Eighty participants were studied under two conditions (exercise vs. non-exercise control) separated by 72 h in a randomized crossover design. Each condition lasted 2 days during which standardized meals were provided. Exercise consisted of 50 min of treadmill walking at 5.0 km/h before the evening meal, while control involved 50 min of sitting. The primary outcome measure was mean glucose during the 24-h period following exercise (or sitting) measured by continuous glucose monitoring. RESULTS Of the 80 participants who were initially randomized, 73 completed both exercise and control. Sixty-three participants [29 males, 34 females; age = 64 ± 8 years, body mass index = 30.5 ± 6.5 kg/m2 and HbA1c = 51 ± 8 mmol/mol (6.8 ± 0.7%), mean ± SD] complied with the standardized diets and had complete continuous glucose monitoring data. Exercise did not affect mean 24-h glucose compared to control (0.03 mmol/L; 95% CI - 0.17, 0.22, P = 0.778) but individual differences between conditions ranged from - 2.8 to +1.8 mmol/L. Exercise did not affect fasting glucose, postprandial glucose or glucose variability. Glucose concentrations measured by continuous glucose monitoring were reduced during the 50 min of walking in exercise compared to sitting in control (- 1.56 mmol/L; 95% CI - 2.18, - 0.95, p < 0.001). CONCLUSION Contrary to previous acute exercise studies, 50 min of walking before dinner in the E-PAraDiGM protocol did not affect 24-h glucose profiles. However, highly heterogeneous responses to exercise were observed. TRIAL REGISTRATION NCT02834689.
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[Effect of a Physical activity program on self-esteem in subjects with chronic diseases. 'Pas a Pas' community intervention trial].
Villalobos, F, Vinuesa, A, Pedret, R, Reche, A, Domínguez, E, Arija, V, ,
Atencion primaria. 2019;(4):236-244
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AIM: To evaluate the effectiveness of a 9 months of supervised Physical Activity (PA) Program with sociocultural activities, on self-esteem and its association on the control of chronic diseases in adult primary care users. DESIGN Multicenter, randomized, controlled community intervention. LOCATION 4 Primary care centers in Reus-Tarragona, Spain. PARTICIPANTS 364 subjects, randomized to the Control Group (CG=104) and Intervention Group (IG=260). INTERVENTION Supervised walking program of 120min/week with sociocultural activities once a month. MAIN MEASUREMENTS At baseline and at post-intervention we assessed: PA (IPAQ-S), self-esteem (Rosenberg scale) and cardiovascular indicators: smoking, systolic (SBP) and diastolic (DBP) blood pressure, serum LDL and HDL cholesterol, and serum glucose. Sociodemographic characteristics and diagnostic of chronic diseases are recorded. RESULTS The Program increased the PA in the IG (P=.001), while it decreased in the CG (P=.002), and also the self-esteem in the group of participants (1.28 points, P=.006) and in the groups with diagnoses of hypertension (1.60 points, P=.005), dyslipidemia (1.62 points, P=.012), excess weight (1.24 points, P=.011) or anxiety/depression (1.53 points, P=.045), assessed by multivariate statistical models. The increase in self-esteem during the intervention decreased SBP -0.5mmHg (P=.030) in the hypertension group, regardless of baseline SBP and the effect of the intervention. CONCLUSION The PA program increased the PA and self-esteem in adult primary care users. The increase of self-esteem improved the control of SBP in hypertensive patients.
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A prospective study of physical activity and fecundability in women with a history of pregnancy loss.
Russo, LM, Whitcomb, BW, Mumford, SL, Hawkins, M, Radin, RG, Schliep, KC, Silver, RM, Perkins, NJ, Kim, K, Omosigho, UR, et al
Human reproduction (Oxford, England). 2018;(7):1291-1298
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STUDY QUESTION Is physical activity (PA) associated with fecundability in women with a history of prior pregnancy loss? SUMMARY ANSWER Higher fecundability was related to walking among overweight/obese women and to vigorous PA in women overall. WHAT IS KNOWN ALREADY PA may influence fecundability through altered endocrine function. Studies evaluating this association have primarily utilized Internet-based recruitment and self-report for pregnancy assessment and have yielded conflicting results. STUDY DESIGN, SIZE, DURATION This is a secondary analysis of the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial (2007-2011), a multisite, randomized controlled trial of preconception-initiated low-dose aspirin. PARTICIPANTS/MATERIALS, SETTING, METHODS Healthy women (n = 1214), aged 18-40 and with 1-2 prior pregnancy losses, were recruited from four US medical centers. Participants were followed for up to six menstrual cycles while attempting pregnancy and through pregnancy for those who became pregnant. Time to hCG detected pregnancy was assessed using discrete-time Cox proportional hazard models to estimate fecundability odds ratios (FOR) adjusted for covariates, accounting for left truncation and right censoring. MAIN RESULTS AND THE ROLE OF CHANCE The association of walking with fecundability varied significantly by BMI (P-interaction = 0.01). Among overweight/obese women, walking ≥10 min at a time was related to improved fecundability (FOR = 1.82, 95% CI: 1.19, 2.77). In adjusted models, women reporting >4 h/wk of vigorous activity had significantly higher fecundability (FOR = 1.69, 95% CI: 1.24, 2.31) compared to no vigorous activity. Associations of vigorous activity with fecundability were not significantly different by BMI (P-interaction = 0.9). Moderate activity, sitting, and International Physical Activity Questionnaire (IPAQ) categories were not associated with fecundability overall or in BMI-stratified analyses. LIMITATIONS, REASONS FOR CAUTION Some misclassification of PA levels as determined by the short form of the IPAQ is likely to have occurred, and may have led to non-differential misclassification of exposure in our study. Information on diet and change in BMI was not collected and may have contributed to some residual confounding in our results. The generalizability of our results may be limited as our population consisted of women with a history of one or two pregnancy losses. WIDER IMPLICATIONS OF THE FINDINGS These findings provide positive evidence for the benefits of PA in women attempting pregnancy, especially for walking among those with higher BMI. Further study is necessary to clarify possible mechanisms through which walking and vigorous activity might affect time-to-pregnancy. STUDY FUNDING/COMPETING INTEREST(S): This work was funded by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors report no conflicts of interest in this work. TRIAL REGISTRATION NUMBER #NCT00467363.
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Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis.
Rogers, LQ, Courneya, KS, Anton, PM, Hopkins-Price, P, Verhulst, S, Robbs, RS, Vicari, SK, McAuley, E
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2017;(2):321-326
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BACKGROUND Most breast cancer survivors do not meet physical activity recommendations. Understanding mediators of physical activity behavior change can improve interventions designed to increase physical activity in this at-risk population. PURPOSE Study aims were to determine the 3-month Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention effects on social cognitive theory constructs and the mediating role of any changes on the increase in accelerometer-measured physical activity previously reported. METHODS Post-treatment breast cancer survivors (N = 222) were randomized to BEAT Cancer or usual care. Assessments occurred at baseline, 3 months (M3), and 6 months (M6). Adjusted linear mixed model analysis of variance determined intervention effects on walking self-efficacy, outcome expectations, goal setting, and perceived barrier interference at M3. Path analysis determined mediation of intervention effects on physical activity at M6 by changes in social cognitive constructs during the intervention (i.e., baseline to M3). RESULTS BEAT Cancer significantly improved self-efficacy, goals, negative outcome expectations, and barriers. Total path analysis model explained 24 % of the variance in M6 physical activity. There were significant paths from randomized intervention group to self-efficacy (β = 0.15, p < .05) and barriers (β = -0.22, p < .01). Barriers demonstrated a borderline significant association with M6 physical activity (β = -0.24, p = .05). No statistically significant indirect effects were found. CONCLUSIONS Although BEAT Cancer significantly improved social cognitive constructs, no significant indirect effects on physical activity improvements 3 months post-intervention were observed (NCT00929617).
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Community Weight Loss to Combat Obesity and Disability in At-Risk Older Adults.
Rejeski, WJ, Ambrosius, WT, Burdette, JH, Walkup, MP, Marsh, AP
The journals of gerontology. Series A, Biological sciences and medical sciences. 2017;(11):1547-1553
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BACKGROUND Among older, overweight, and obese adults with either cardiovascular disease or the metabolic syndrome, reduced mobility and loss of leg strength are important risk factors for morbidity, disability, and mortality. It is unclear whether community-based approaches to weight loss may be an effective solution to this public health challenge. METHODS An 18-month three-site, randomized controlled trial conducted by YMCA staff, with blinded assessors, enrolled 249 older, overweight, and obese adults with either cardiovascular disease or metabolic syndrome with randomization to three interventions: weight loss alone (WL), weight loss + aerobic training (WL + AT), and weight loss + resistance training (WT + RT). The dual primary outcomes were 400-m walk time in seconds and knee extensor strength in Newton meters. RESULTS All groups lost weight from baseline: average baseline adjusted change of -6.1% (95% confidence interval [CI]: -7.5 to -4.7) for WL only, -8.6% (95% CI: -10.0 to -7.2) for WL + AT, and -9.7% (95% CI: -11.1 to -8.4) for WL + RT. Combined, the two physical activity + WL training groups had greater improvement in walk time than WL alone (mean difference 16.9 seconds [95% CI: 9.7 to 24.0], p < .0001). Baseline adjusted change in knee extensor strength was no greater with WL + RT than WL + AT (mean difference -3.6 Nm [95% CI: -7.5 to 0.3], p = .07). CONCLUSIONS At risk, older, overweight and obese adults can achieve clinically significant reductions in body weight with community-based weight loss programs. The change in percent weight loss and improvements in mobility are significantly enhanced when either RT or AT is combined with dietary WL.
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Walking Away from Type 2 diabetes: a cluster randomized controlled trial.
Yates, T, Edwardson, CL, Henson, J, Gray, LJ, Ashra, NB, Troughton, J, Khunti, K, Davies, MJ
Diabetic medicine : a journal of the British Diabetic Association. 2017;(5):698-707
Abstract
AIMS: This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. METHODS Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. RESULTS Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. CONCLUSIONS A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months.