7 research outputs found

    Effectiveness of a short-term and simple exercise training program for older adults

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    While there have been many studies determining the effectiveness of training programs to decrease fall risk in the elderly, most of them require special equipment, leader training, or major time commitments (more than 8 weeks, multiple times per week). Individuals older than 66 years old identified an exercise program offered at home, twice a week, lasting 10 or 30 minutes, and with no associated cost as being more attractive than other training program options offered (Franco et al., 2015). The objective of this study was to determine the effectiveness of a simple six-week exercise program on fall risk factors. Thirty-eight older adults were assigned to a Training Group or a Control Group. Investigator-led balance and lower extremity strength exercises were performed twice a week. Mobility, leg strength and postural sway were measured before and after the six weeks for both groups. A survey determined perceptions of participant abilities and fear of falling at three different times. Timed Up and Go times decreased (p = .008), leg strength increased (p = .022), and postural sway decreased in the anteroposterior direction and overall, for the Training Group (p < .05) while the Control group displayed no differences. Surveys administered determined no differences for the Control group, but the Training Group perceived that they had better balance, mobility, and leg strength and a decreased fear of falling (p < .05). This simple training program led to changes that would likely decrease fall risk and did so in an extremely short time

    Personalized Research on Diet in Ulcerative Colitis and Crohn\u27s Disease: A Series of N-of-1 Diet Trials

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    INTRODUCTION: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant\u27s baseline, usual diet (UD). METHODS: Across 19 sites, we recruited patients aged 7–18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets. RESULTS: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was \u3c1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was −0.3 (95% credible interval −1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not. DISCUSSION: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness

    Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn\u27s Disease: A Pragmatic Randomized Trial

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    BACKGROUND & AIMS: Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn\u27s disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. METHODS: Patients with pediatric Crohn\u27s disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12-36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. RESULTS: Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45-1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55-1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19-0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49-1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24-2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. CONCLUSIONS: Among adalimumab but not infliximab initiators, patients with pediatric Crohn\u27s disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. CLINICALTRIALS: gov, Number: NCT02772965

    Personalized Research on Diet in Ulcerative Colitis and Crohn\u27s Disease: A Series of N-of-1 Diet Trials

    No full text
    INTRODUCTION: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant\u27s baseline, usual diet (UD). METHODS: Across 19 sites, we recruited patients aged 7–18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets. RESULTS: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was \u3c1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was −0.3 (95% credible interval −1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not. DISCUSSION: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness
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