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Objectives: This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA. Design: Cross-sectional study with post hoc analysis of a randomised controlled study. Setting: University Hospital, Sweden. Participants 79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test. Intervention: The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care. Outcome measures Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test. Results: Multiple regression analyses showed that age (standardised beta -0.33, 95% CI -3.8 to -1.05, p<0.001), sex (-0.24, 95% CI -66.9 to -8.0, p=0.014), no comorbidity (-0.16, 95% CI -55.5 to 5.4, p=0.11), baseline BMI (-0.29, 95% CI -8.1 to -1.6, p=0.004), baseline 6 min walk test (-0.55, 95% CI -0.5 to -0.3, p<0.001) were associated with changes in 6 min walk test 3 months after the stroke event. The regression model described 36% of the variance in changes in the 6 min walk test. Conclusions: Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Objectives: This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA. Design: Cross-sectional study with post hoc analysis of a randomised controlled study. Setting: University Hospital, Sweden. Participants 79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test. Intervention: The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care. Outcome measures Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test. Results: Multiple regression analyses showed that age (standardised beta -0.33, 95% CI -3.8 to -1.05, p<0.001), sex (-0.24, 95% CI -66.9 to -8.0, p=0.014), no comorbidity (-0.16, 95% CI -55.5 to 5.4, p=0.11), baseline BMI (-0.29, 95% CI -8.1 to -1.6, p=0.004), baseline 6 min walk test (-0.55, 95% CI -0.5 to -0.3, p<0.001) were associated with changes in 6 min walk test 3 months after the stroke event. The regression model described 36% of the variance in changes in the 6 min walk test. Conclusions: Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Objectives: This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA. Design: Cross-sectional study with post hoc analysis of a randomised controlled study. Setting: University Hospital, Sweden. Participants 79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test. Intervention: The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care. Outcome measures Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test. Results: Multiple regression analyses showed that age (standardised beta -0.33, 95% CI -3.8 to -1.05, p<0.001), sex (-0.24, 95% CI -66.9 to -8.0, p=0.014), no comorbidity (-0.16, 95% CI -55.5 to 5.4, p=0.11), baseline BMI (-0.29, 95% CI -8.1 to -1.6, p=0.004), baseline 6 min walk test (-0.55, 95% CI -0.5 to -0.3, p<0.001) were associated with changes in 6 min walk test 3 months after the stroke event. The regression model described 36% of the variance in changes in the 6 min walk test. Conclusions: Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Objectives: This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA. Design: Cross-sectional study with post hoc analysis of a randomised controlled study. Setting: University Hospital, Sweden. Participants 79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test. Intervention: The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care. Outcome measures Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test. Results: Multiple regression analyses showed that age (standardised beta -0.33, 95% CI -3.8 to -1.05, p<0.001), sex (-0.24, 95% CI -66.9 to -8.0, p=0.014), no comorbidity (-0.16, 95% CI -55.5 to 5.4, p=0.11), baseline BMI (-0.29, 95% CI -8.1 to -1.6, p=0.004), baseline 6 min walk test (-0.55, 95% CI -0.5 to -0.3, p<0.001) were associated with changes in 6 min walk test 3 months after the stroke event. The regression model described 36% of the variance in changes in the 6 min walk test. Conclusions: Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Objectives: This study aimed to identify factors related to changes in walking performance in individuals 3 months after a stroke or TIA. Design: Cross-sectional study with post hoc analysis of a randomised controlled study. Setting: University Hospital, Sweden. Participants 79 individuals, 64 (10) years, 37% women, who were acutely hospitalised because of stroke or TIA between November 2016 and December 2018. Inclusion criteria were patients aged 18 or above and the major eligibility criterion was the ability to perform the 6 min walking test. Intervention: The intervention group received standard care plus daily mobile phone text messages (short message service) with instructions to perform regular outdoor walking and functional leg exercises in combination with step counting and training diaries. The control group received standard care. Outcome measures Multivariate analysis was performed and age, sex, group allocation, comorbidity, baseline 6 min walk test, body mass index (BMI), cognition and chair-stand tests were entered as possible determinants for changes in the 6 min walk test. Results: Multiple regression analyses showed that age (standardised beta -0.33, 95% CI -3.8 to -1.05, p<0.001), sex (-0.24, 95% CI -66.9 to -8.0, p=0.014), no comorbidity (-0.16, 95% CI -55.5 to 5.4, p=0.11), baseline BMI (-0.29, 95% CI -8.1 to -1.6, p=0.004), baseline 6 min walk test (-0.55, 95% CI -0.5 to -0.3, p<0.001) were associated with changes in 6 min walk test 3 months after the stroke event. The regression model described 36% of the variance in changes in the 6 min walk test. Conclusions: Post hoc regression analyses indicated that younger age, male sex, lower BMI and shorter 6 min walk test at baseline and possible no comorbidity contributed to improvement in walking performance at 3 months in patients with a recent stroke or TIA. These factors may be important when planning secondary prevention actions.

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management., Funding Agencies|Empros Pharma AB

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management., Funding Agencies|Empros Pharma AB

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management., Funding Agencies|Empros Pharma AB

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management.

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management., Funding Agencies|Empros Pharma AB

Objective The aim of this study was to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (denoted EMP16) on relative body weight after 26 weeks compared with placebo. Methods The randomized, double-blind, placebo-controlled trial had a 26-week treatment period, with dose escalation up to 6 weeks. Participants, adults between ages 18 and 75 years, with BMI >= 30 kg/m(2) or >= 28 kg/m(2) with risk factors, were randomly assigned to EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo. The primary end point was relative weight loss from baseline to week 26 assessed in participants with at least one post-baseline weight measurement. Results Of 156 randomized participants, 149 constituted the intention-to-treat population. The mean (95% CI) estimated treatment difference to placebo in relative weight loss after 26 weeks in the intention-to-treat population was -4.70% (-6.16% to -3.24%; p < 0.0001) with EMP16-120/40 and -5.42% (-6.60% to -4.24%; p < 0.0001) with EMP16-150/50. Conclusions This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management., Funding Agencies|Empros Pharma AB

OBJECTIVE: To evaluate whetherdaily mobile-phone delivered messages with training instructions during three months increase physical activity and overall mobility in patients soon after stroke or transient ischemic attack. DESIGN: Randomised controlled trial with intention-to-treat analyses. SETTING: University hospital. Data collection from November 2016 until December2018. SUBJECTS: Seventy-nine patients (mean (SD) age 63.9 (10.4) years, 29 were women) were allocated to either intervention (n = 40) or control group (n = 39). Participants had to be independent (modified Ranking Scale ⩽2) and able to perform the six-minute walking test at discharge from the hospital. INTERVENTIONS: The intervention group received standard care and daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care; that is, primary care follow-up. MAIN MEASURES: Walking performance by six-minute walking test (m), lower body strength by five times chair-stand test (s), the short physical performance battery (0-12 points) and 10-metres walk test (m/s) were assessed at baseline and after three months. RESULTS: The estimated median difference in the six-minute walking test was in favour of the intervention group by 30 metres (95% CI, 55 to 1; effect size 0.64; P = 0.037) and in the chair-stand test by 0.88 seconds (95% CI, 0.02 to 1.72; effect size 0.64; P = 0.034). There were no differences between groups on the short physical performance battery or in 10-metres walking time. CONCLUSIONS: Three months of daily mobile phone text messages with guided training instructions improved composite mobility measures; that is, walking performanceand lower body strength. CLINICAL TRIAL REGISTRY: The study is registered with ClinicalTrials.gov, number NCT02902367.

OBJECTIVE: To evaluate whetherdaily mobile-phone delivered messages with training instructions during three months increase physical activity and overall mobility in patients soon after stroke or transient ischemic attack. DESIGN: Randomised controlled trial with intention-to-treat analyses. SETTING: University hospital. Data collection from November 2016 until December2018. SUBJECTS: Seventy-nine patients (mean (SD) age 63.9 (10.4) years, 29 were women) were allocated to either intervention (n = 40) or control group (n = 39). Participants had to be independent (modified Ranking Scale ⩽2) and able to perform the six-minute walking test at discharge from the hospital. INTERVENTIONS: The intervention group received standard care and daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care; that is, primary care follow-up. MAIN MEASURES: Walking performance by six-minute walking test (m), lower body strength by five times chair-stand test (s), the short physical performance battery (0-12 points) and 10-metres walk test (m/s) were assessed at baseline and after three months. RESULTS: The estimated median difference in the six-minute walking test was in favour of the intervention group by 30 metres (95% CI, 55 to 1; effect size 0.64; P = 0.037) and in the chair-stand test by 0.88 seconds (95% CI, 0.02 to 1.72; effect size 0.64; P = 0.034). There were no differences between groups on the short physical performance battery or in 10-metres walking time. CONCLUSIONS: Three months of daily mobile phone text messages with guided training instructions improved composite mobility measures; that is, walking performanceand lower body strength. CLINICAL TRIAL REGISTRY: The study is registered with ClinicalTrials.gov, number NCT02902367.

OBJECTIVE: To evaluate whetherdaily mobile-phone delivered messages with training instructions during three months increase physical activity and overall mobility in patients soon after stroke or transient ischemic attack. DESIGN: Randomised controlled trial with intention-to-treat analyses. SETTING: University hospital. Data collection from November 2016 until December2018. SUBJECTS: Seventy-nine patients (mean (SD) age 63.9 (10.4) years, 29 were women) were allocated to either intervention (n = 40) or control group (n = 39). Participants had to be independent (modified Ranking Scale ⩽2) and able to perform the six-minute walking test at discharge from the hospital. INTERVENTIONS: The intervention group received standard care and daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care; that is, primary care follow-up. MAIN MEASURES: Walking performance by six-minute walking test (m), lower body strength by five times chair-stand test (s), the short physical performance battery (0-12 points) and 10-metres walk test (m/s) were assessed at baseline and after three months. RESULTS: The estimated median difference in the six-minute walking test was in favour of the intervention group by 30 metres (95% CI, 55 to 1; effect size 0.64; P = 0.037) and in the chair-stand test by 0.88 seconds (95% CI, 0.02 to 1.72; effect size 0.64; P = 0.034). There were no differences between groups on the short physical performance battery or in 10-metres walking time. CONCLUSIONS: Three months of daily mobile phone text messages with guided training instructions improved composite mobility measures; that is, walking performanceand lower body strength. CLINICAL TRIAL REGISTRY: The study is registered with ClinicalTrials.gov, number NCT02902367.

The safety of a novel modified-release oral capsule with orlistat and acarbose (MR-OA) was investigated in 67 obese middle-aged White men with a body mass index of 32 to 40 kg/m2 or 30 to 32 kg/m2 plus waist circumference >102 cm. The purpose of this investigation was to compare MR-OA with the existing conventional orlistat regarding systemic safety defined as plasma orlistat concentration at the end of the treatment period of 14 days. Participants took the MR-OA fixed-dose combination formulation 3 times a day together with a major meal. Three different doses of MR-OA were evaluated-60/20, 90/30, and 120/40 (mg orlistat/mg acarbose)-as well as 1 reference group who received the conventional orlistat, Xenical, with 120 mg of orlistat. Blood plasma was sampled on days 1 and 14. The orlistat plasma concentrations of the MR-OA dose showed a delayed absorption and were lower compared with conventional orlistat at the end of the study. All doses were safe and well tolerated without any unexpected adverse events and no serious adverse events. The delay in the rise of orlistat plasma concentration indicates that the modified-release properties of the MR-OA formulation are effective. The systemic exposure of orlistat resulting from MR-OA was similar, albeit a bit lower than the conventional orlistat with 120 mg of orlistat. We can therefore assume that the safety profile regarding the orlistat moiety of MR-OA is comparable to the conventional orlistat and a promising approach for weight control in obese patients. Further clinical evaluation is underway.

Objectives To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke. Design Randomised controlled intervention study with per-protocol analyses. Setting University Hospital in Sweden. Participants Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) >= 18 years with good motor function (modified Rankin Scale <= 2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations. Interventions The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care. Main outcome measures Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months. Results Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (-1.30 kg, 95% CI -2.45 to -0.14; p=0.029, ES=0.41 vs -0.76 kg, 95% CI -1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol -0.65 mmol/L, 95% CI -1.10 to -0.2; p=0.06, ES: 0.5 vs -1.1 mmol/L, 95% CI -1.47 to -0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups. Conclusions No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived hea

The safety of a novel modified-release oral capsule with orlistat and acarbose (MR-OA) was investigated in 67 obese middle-aged White men with a body mass index of 32 to 40 kg/m2 or 30 to 32 kg/m2 plus waist circumference >102 cm. The purpose of this investigation was to compare MR-OA with the existing conventional orlistat regarding systemic safety defined as plasma orlistat concentration at the end of the treatment period of 14 days. Participants took the MR-OA fixed-dose combination formulation 3 times a day together with a major meal. Three different doses of MR-OA were evaluated-60/20, 90/30, and 120/40 (mg orlistat/mg acarbose)-as well as 1 reference group who received the conventional orlistat, Xenical, with 120 mg of orlistat. Blood plasma was sampled on days 1 and 14. The orlistat plasma concentrations of the MR-OA dose showed a delayed absorption and were lower compared with conventional orlistat at the end of the study. All doses were safe and well tolerated without any unexpected adverse events and no serious adverse events. The delay in the rise of orlistat plasma concentration indicates that the modified-release properties of the MR-OA formulation are effective. The systemic exposure of orlistat resulting from MR-OA was similar, albeit a bit lower than the conventional orlistat with 120 mg of orlistat. We can therefore assume that the safety profile regarding the orlistat moiety of MR-OA is comparable to the conventional orlistat and a promising approach for weight control in obese patients. Further clinical evaluation is underway.

Objectives To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke. Design Randomised controlled intervention study with per-protocol analyses. Setting University Hospital in Sweden. Participants Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) >= 18 years with good motor function (modified Rankin Scale <= 2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations. Interventions The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care. Main outcome measures Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months. Results Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (-1.30 kg, 95% CI -2.45 to -0.14; p=0.029, ES=0.41 vs -0.76 kg, 95% CI -1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol -0.65 mmol/L, 95% CI -1.10 to -0.2; p=0.06, ES: 0.5 vs -1.1 mmol/L, 95% CI -1.47 to -0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups. Conclusions No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived hea

The safety of a novel modified-release oral capsule with orlistat and acarbose (MR-OA) was investigated in 67 obese middle-aged White men with a body mass index of 32 to 40 kg/m2 or 30 to 32 kg/m2 plus waist circumference >102 cm. The purpose of this investigation was to compare MR-OA with the existing conventional orlistat regarding systemic safety defined as plasma orlistat concentration at the end of the treatment period of 14 days. Participants took the MR-OA fixed-dose combination formulation 3 times a day together with a major meal. Three different doses of MR-OA were evaluated-60/20, 90/30, and 120/40 (mg orlistat/mg acarbose)-as well as 1 reference group who received the conventional orlistat, Xenical, with 120 mg of orlistat. Blood plasma was sampled on days 1 and 14. The orlistat plasma concentrations of the MR-OA dose showed a delayed absorption and were lower compared with conventional orlistat at the end of the study. All doses were safe and well tolerated without any unexpected adverse events and no serious adverse events. The delay in the rise of orlistat plasma concentration indicates that the modified-release properties of the MR-OA formulation are effective. The systemic exposure of orlistat resulting from MR-OA was similar, albeit a bit lower than the conventional orlistat with 120 mg of orlistat. We can therefore assume that the safety profile regarding the orlistat moiety of MR-OA is comparable to the conventional orlistat and a promising approach for weight control in obese patients. Further clinical evaluation is underway.

Objectives To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke. Design Randomised controlled intervention study with per-protocol analyses. Setting University Hospital in Sweden. Participants Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) >= 18 years with good motor function (modified Rankin Scale <= 2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations. Interventions The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care. Main outcome measures Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months. Results Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (-1.30 kg, 95% CI -2.45 to -0.14; p=0.029, ES=0.41 vs -0.76 kg, 95% CI -1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol -0.65 mmol/L, 95% CI -1.10 to -0.2; p=0.06, ES: 0.5 vs -1.1 mmol/L, 95% CI -1.47 to -0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups. Conclusions No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived hea

The safety of a novel modified-release oral capsule with orlistat and acarbose (MR-OA) was investigated in 67 obese middle-aged White men with a body mass index of 32 to 40 kg/m2 or 30 to 32 kg/m2 plus waist circumference >102 cm. The purpose of this investigation was to compare MR-OA with the existing conventional orlistat regarding systemic safety defined as plasma orlistat concentration at the end of the treatment period of 14 days. Participants took the MR-OA fixed-dose combination formulation 3 times a day together with a major meal. Three different doses of MR-OA were evaluated-60/20, 90/30, and 120/40 (mg orlistat/mg acarbose)-as well as 1 reference group who received the conventional orlistat, Xenical, with 120 mg of orlistat. Blood plasma was sampled on days 1 and 14. The orlistat plasma concentrations of the MR-OA dose showed a delayed absorption and were lower compared with conventional orlistat at the end of the study. All doses were safe and well tolerated without any unexpected adverse events and no serious adverse events. The delay in the rise of orlistat plasma concentration indicates that the modified-release properties of the MR-OA formulation are effective. The systemic exposure of orlistat resulting from MR-OA was similar, albeit a bit lower than the conventional orlistat with 120 mg of orlistat. We can therefore assume that the safety profile regarding the orlistat moiety of MR-OA is comparable to the conventional orlistat and a promising approach for weight control in obese patients. Further clinical evaluation is underway.

Objectives To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke. Design Randomised controlled intervention study with per-protocol analyses. Setting University Hospital in Sweden. Participants Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) >= 18 years with good motor function (modified Rankin Scale <= 2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations. Interventions The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care. Main outcome measures Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months. Results Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (-1.30 kg, 95% CI -2.45 to -0.14; p=0.029, ES=0.41 vs -0.76 kg, 95% CI -1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol -0.65 mmol/L, 95% CI -1.10 to -0.2; p=0.06, ES: 0.5 vs -1.1 mmol/L, 95% CI -1.47 to -0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups. Conclusions No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived hea

The safety of a novel modified-release oral capsule with orlistat and acarbose (MR-OA) was investigated in 67 obese middle-aged White men with a body mass index of 32 to 40 kg/m2 or 30 to 32 kg/m2 plus waist circumference >102 cm. The purpose of this investigation was to compare MR-OA with the existing conventional orlistat regarding systemic safety defined as plasma orlistat concentration at the end of the treatment period of 14 days. Participants took the MR-OA fixed-dose combination formulation 3 times a day together with a major meal. Three different doses of MR-OA were evaluated-60/20, 90/30, and 120/40 (mg orlistat/mg acarbose)-as well as 1 reference group who received the conventional orlistat, Xenical, with 120 mg of orlistat. Blood plasma was sampled on days 1 and 14. The orlistat plasma concentrations of the MR-OA dose showed a delayed absorption and were lower compared with conventional orlistat at the end of the study. All doses were safe and well tolerated without any unexpected adverse events and no serious adverse events. The delay in the rise of orlistat plasma concentration indicates that the modified-release properties of the MR-OA formulation are effective. The systemic exposure of orlistat resulting from MR-OA was similar, albeit a bit lower than the conventional orlistat with 120 mg of orlistat. We can therefore assume that the safety profile regarding the orlistat moiety of MR-OA is comparable to the conventional orlistat and a promising approach for weight control in obese patients. Further clinical evaluation is underway.

Objectives To evaluate effects of mobile phone text-messaging exercise instructions on body composition, cardiometabolic risk markers and self-reported health at 3 months after stroke. Design Randomised controlled intervention study with per-protocol analyses. Setting University Hospital in Sweden. Participants Seventy-nine patients (mean (SD) age 64 (10) years, 37% female) >= 18 years with good motor function (modified Rankin Scale <= 2) and capable to perform 6 min walking test at hospital discharge were randomised to either intervention (n=40) or control group (n=39). Key exclusion criteria: subarachnoid bleeding, uncontrolled hypertension, severe psychiatric problems or cognitive limitations. Interventions The intervention group received beyond standard care, daily mobile phone instructional text messages to perform regular outdoor walking and functional leg exercises. The control group received standard care. Main outcome measures Fat mass and fat-free mass were estimated by bioelectric impedance analysis. Cardiometabolic risk factors like blood lipids, glycated haemoglobin and blood glucose were analysed at baseline and after 3 months. Results Both groups changed favourably in fat-free mass (1.83 kg, 95% CI 0.77 to 2.89; p=0.01, effect size (ES)=0.63 vs 1.22 kg, 95% CI 0.39 to 2.0; p=0.05, ES=0.54) and fat mass (-1.30 kg, 95% CI -2.45 to -0.14; p=0.029, ES=0.41 vs -0.76 kg, 95% CI -1.74 to 0.22; p=0.123, ES=0.28). Also, many cholesterol related biomarkers improved; for example, total cholesterol -0.65 mmol/L, 95% CI -1.10 to -0.2; p=0.06, ES: 0.5 vs -1.1 mmol/L, 95% CI -1.47 to -0.56; p>0.001, ES=0.8. However, there were no between-group differences. At 3 months, 94% and 86%, respectively, reported very good/fairly good health in the text messaging and control groups. Conclusions No clear effect of 3 months daily mobile phone delivered training instructions was detected on body composition, cardiovascular biochemical risk factors or self-perceived hea

Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m(-2) or BMIs 30 to 32 kg m(-2) and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.

Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m(-2) or BMIs 30 to 32 kg m(-2) and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.

Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m(-2) or BMIs 30 to 32 kg m(-2) and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.

Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m(-2) or BMIs 30 to 32 kg m(-2) and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.

Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m(-2) or BMIs 30 to 32 kg m(-2) and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.

Objective There is an unmet medical need for a safe and effective weight loss product with minimal systemic side-effects. In this study, the effect of a novel modified-release fixed-dose combination of orlistat and acarbose (MR-OA) was compared with conventional orlistat (CO) regarding tolerability, appetite and glucose metabolism. Methods Sixty-seven men with obesity, aged 24 to 60 years with body mass indexes (BMIs) 33 to 40 kg m(-2) or BMIs 30 to 32 kg m(-2) and waist circumference above 102 cm were included. They were randomized to either three different doses of the test formulation MR-OA (60 mg orlistat/20 mg acarbose, 90/30 and 120/40) or CO (Xenical, 120 mg orlistat) for a 2-week study of daily treatment. The participants spent days 1 and 14 at the clinical research centre where they received standardized meals, had blood sampling and filled in questionnaires regarding tolerability and appetite after meals. In days 2 to 13, the participants were at home and continued to fill in the questionnaires daily. Results In the MR-OA groups, reports of liquid and oily stools as well as faecal incontinence were fewer, whereas reports of gastric distension and flatulence were higher, compared with the CO group. More participants reported decreased hunger in the 90/30 and 120/40 MR-OA, and postprandial plasma glucose concentration was reduced in all MR-OA groups compared with CO. Conclusions This study shows that by using a modified-release dosage form, orlistat and acarbose can be combined without compromising tolerability. Furthermore, MR-OA shows promising effects regarding reduction of appetite and reduces postprandial glucose. Tolerability is coupled to compliance and thereby efficacy of a treatment; therefore, this novel combination MR-OA could be an effective approach for weight loss treatment. A follow-up study in a more diverse population and for a longer duration with weight loss as primary outcome variable is planned.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

Physical activity in community-living individuals after a stroke is usually scarce. This protocol describes a study that will evaluate a method to increase physical activity by performing a 3-month outdoor walking and muscle strengthening program and will examine the 3-month and 1-year effects of this program on individuals with acute stroke (AS) or transient ischemic attack (TIA). In a prospective randomized controlled trial in Uppsala, Sweden, 80 individuals with AS or TIA who maintained cognitive and motor function will be randomized into groups for continuous training for three months or for regular standard care. The training will be supervised by daily cellphone-delivered messages (short message services; SMS), and the intensity, duration and workload will be gradually increased. The primary outcome is a change in walking capacity according to the 6-Minute Walk Test and chair-rising at three months. Secondary outcomes include mobility, gait speed, handgrip strength, body composition (fat mass and muscle mass), biochemical risk-markers, health-related quality of life, and cardiovascular events. Adherence to the training program will be documented with a self-reported diary and step counts over two weeks. The major study started in November 2016, and results are expected in 2019. In a pilot study of 15 subjects post-stroke (mean-age 65 years), we observed improved walking capacity (increasing from 23 to 255 m) and chair-rising (decreasing 2.42 s) from baseline to three months. SMS-guided outdoor training will be tested as a potential therapeutic strategy to increase physical activity and thereby improve walking capacity and physical function following a stroke.

AIM: To investigate if occurrence of newly diagnosed exercise induced bronchoconstriction (EIB) would affect adolescents' ability to assess their physical activity. METHODS: 99 selected adolescents with and 47 adolescents without self-reported exercise induced dyspnea were included. All of the 146 adolescents then performed a standardized exercise challenge test on a treadmill with dry-air inhalation to detect EIB. Free living physical activity was assessed during seven days with both accelerometer (objective assessment) and a validated activity diary (subjective assessment). Height, weight and subjective sleep were recorded. RESULTS: Out of the 146 adolescents 49 were diagnosed with EIB. Forty-six of the adolescents with EIB (35 girls and 11 boys) and 84 of the control adolescents (45 girls and 39 boys) had complete 7 day activity diary and accelerometer data. There were no differences in age, BMI and sleep between EIB and control adolescents. Boys with EIB overestimated subjective assessment compared to objective assessment more than girls with EIB. No difference was seen between control boys and girls. Furthermore, boys with EIB reported a much higher frequency of high intensity exercise than girls with EIB, but no difference was observed between control boys and girls. CONCLUSION: Adolescent boys with newly diagnosed EIB overestimated their physical activity compared to EIB girls. Caution may thus be used when choosing methods measuring level of physical activity in this group and especially when investigating gender differences.

BACKGROUND: Concerns for the possibility of an excessive loss of fat-free mass (FFM) and resting metabolic rate (RMR) after bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) and duodenal switch (BPD/DS), have been raised. OBJECTIVES: This study aims to examine body composition and RMR in patients after RYGB and BPD/DS and in non-operated controls. METHODS: Body composition and RMR were studied with Bod Pod and indirect calorimetry in weight-stable RYGB (n = 15) and BPD/DS patients (n = 12) and compared with non-operated controls (n = 17). All patients were 30-55 years old and weight stable with BMI 28-35 kg/m(2). RESULTS: FFM% was 58% (RYGB), 61% (BPD/DS), and 58% (controls). Body composition did not differ after RYGB and BPD/DS compared to controls, despite 27 and 40% total body weight loss, respectively. No difference in RMR or RMR/FFM was observed (1539, 1617, and 1490 kcal/24 h; and 28.9, 28.4, and 28.8 kcal/24 h/kg). CONCLUSION: Weight-stable patients with BMI 28-35 kg/m(2) after RYGB and BPD/DS have a body composition and RMR similar to that of non-operated individuals within the same BMI interval.

Background: Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability. Objective: To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia. Design: A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention. Results: Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95% confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045. Conclusions: This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further in